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“

Effectiveness of a diabetes education and self

management programme (DESMOND) for people with newly diagnosed type diabetes

mellitus! three year follow"up of a cluster

randomised controlled trial in primary care

BMJ 2012; 344 doi: http://dx.doi.org/10.1136/bmj.e2333 (Publihed 26 !pril

2012" #ite thi $: BMJ 2012;344:e2333

Kamlesh Khunti, professor of primary care diabetes and vascular

medicine1, Laura J Gray, lecturer of population and public healthsciences1,Timothy Skinner, director rural clinical school2, Marian E Carey,

national director !ESM"#! pro$ramme3, Kathryn %ealf, researchassistant3,&elen !allosso, research associate3, &arriet 'isher, research

assistant1, Michael Campbell, professor of medical statistics4, Simon &eller,professor of clinical diabetes5, Melanie J !avies, professor in diabetes

medicine6

(bstract

"b)ective To measure whether the benefits of a single education and selfmanagement structured programme for people with newly diagnosed type 2

diabetes mellitus are sustained at three years.

!esi$n Three year follow-up of a multicentre cluster randomised controlled trial in

primary care, with randomisation at practice leel.

Settin$ 2!" general practices in 13 primary care sites in the #nited $ingdom.

*articipants "31 of the %24 participants included in the original trial were eligiblefor follow-up. &iomedical data were collected on 6!4 '%2.6() and *uestionnaire

data on 513 '"!.1() participants.

+ntervention + structured group education programme for si hours deliered in

the community by two trained healthcare professional educators compared with

usual care.

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Main outcome measures The primary outcome was glycated haemoglobin'b+1c) leels. The secondary outcomes were blood pressure, weight, blood lipid

leels, smoing status, physical actiity, *uality of life, beliefs about illness,depression, emotional impact of diabetes, and drug use at three years.

%esults b+1c leels at three years had decreased in both groups. +fter ad/ustingfor baseline and cluster the difference was not significant 'difference 0!.!2, 5(

confidence interal 0!.22 to !.1"). The groups did not differ for the other biomedical and lifestyle outcomes and drug use. The significant benefits in the

interention group across four out of fie health beliefs seen at 12 months weresustained at three years '!.!1). epression scores and *uality of life did not

differ at three years.

Conclusion + single programme for people with newly diagnosed type 2 diabetes

mellitus showed no difference in biomedical or lifestyle outcomes at three yearsalthough there were sustained improements in some illness beliefs.

Trial re$istration urrent ontrolled Trials 78T91"%44!16.

+ntroduction

Type 2 diabetes mellitus is a serious, progressie condition presenting with chronichyperglycaemia, and its prealence is increasing globally. n the short term, type 2

diabetes may lead to symptoms and debility and in the long term to seriouscomplications, including blindness, renal failure, and amputation. :urthermore,

three *uarters of people with type 2 diabetes will die from cardioasculardisease.- Traditionally, treatment for the condition has centred on drug

interentions to stabilise hyperglycaemia and to manage cardioascular risfactors, including blood pressure and lipids, to preent associated symptoms and

reduce the ris of ascular complications oer time.. ;ong term follow-up datafrom the #nited $ingdom rospectie iabetes 7tudy has shown that despite early

successes, metabolic control progressiely worsens with time, warrantingeploration of alternatie approaches for long term management of type 2

diabetes./

+nyone with diabetes, including type 2 diabetes, has to mae multiple daily

choices about the management of their condition, such as appropriate dietaryintae, physical actiity, and adherence to drugs, often with minimal input from a

healthcare professional.0 n recent years, programmes to educate people about selfmanagement hae become the focus of attention among healthcare professionals

and are adocated for people with type 2 diabetes as a means to ac*uire the sillsnecessary for actie responsibility in the day to day self management of their

condition.1 2 3 4 5 n addition, it has been suggested that education on selfmanagement may play a piotal role in tacling beliefs about health and so

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improe metabolic control, concordance with drug decisions, ris factors, and*uality of life. - .

cellence guidelines for diabetes,0 national serice framewor fordiabetes,4 and the 2!11 *uality standards from 9>, adocate the proision of

self management education from diagnosis. The diabetes education and selfmanagement for ongoing and newly diagnosed '>7?@9) interention was one

of the first programmes to meet the *uality criteria for education programmes thatare listed by the epartment of ealth and iabetes #$ atient Aoring 7?@9 is currently aailable in 1!3 health organisations across the#nited $ingdom, 8epublic of reland, ngland

and 7cotland. 8andomisation too place at the leel of the general practice tominimise contamination between participants, with stratification by training status

and type of contract with the primary care organisation '

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the #niersity of 7heffield using 8andom ;og. +t each site a local coordinatoroersaw the trial, recruited and trained practices, and maintained contact with

practice staff. erformance of the sites and local coordinators was monitoredregularly, with each site receiing a isit before the trial and a minimum of one

monitoring isit per year. ractice staff sent biomedical data to the localcoordinator for forwarding to the central coordinating centre.

ndiiduals were referred within si wees of diagnosis to the study, with those inthe interention arm attending a structured education programme within 12 wees

of diagnosis. articipants in the original trial were ecluded if they were aged lessthan 1% years, had seere and enduring mental health problems, were not primarily

responsible for their own care, were unable to participate in a group programme'for eample, were housebound or unable to communicate in >nglish), or were

participating in another research study. 8ecruitment too place between @ctober

2!!4 and Banuary 2!!6. >eryone who consented to /oin the original trial waseligible for follow-up at three years unless they had withdrawn during the trial ortheir practice informed us they were no longer at the practice or that it would be

inappropriate to contact them 'for eample, owing to serious illness).

The intervention

The structured group education programme is based on a series of psychological

theories of learningC ;eenthalDs common sense theory,-- dual processtheory,-.and social learning theory.-/ The philosophy of the programme was

founded on patient empowerment, as eidenced in published wor.-0 -1

The interention was deised as a group education programme, with a written

curriculum suitable for a wide range of participants, deliered in a communitysetting, and integrated into routine care. 8egistered healthcare professionals

receied formal training to delier the programme and were supported by a *ualityassurance component of internal and eternal assessment to ensure consistency of

deliery. The programme was si hours long, delierable in either one full day ortwo half day e*uialents, and facilitated by two educators. ;earning was elicited

rather than taught, with the behaiour of the educators promoting a non-didacticapproach. ?ost of the curriculum focused on lifestyle factors, such as food

choices, physical actiity, and cardioascular ris factors. The programme actiates participants to consider their own personal ris factors and, in eeping with

theories of self efficacy, to choose a specific achieable goal to wor on. -/ The broad content of the curriculum and an oeriew of the *uality assurance hae

been reported elsewhere.2

The methods followed for the present study were similar to those of the original

trial. articipants were sent a postal *uestionnaire two wees before the three year

follow-up date. + reminder letter and further copy of the *uestionnaire were sent ifthe original *uestionnaire was not returned within three wees. ractices were

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contacted at the same time and ased to forward the most recent biomedicalmeasurements on the participants to see if differences to biomedical and

psychosocial outcomes could be sustained at three years.

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%esults

@f the %24 indiiduals who consented to tae part from the 2!" general practices'3%" control and 43" interention) to the original trial, "43 '!.2() were eligible

for follow-up at three years. @f those not eligible, 26 died, 44 withdrew from thestudy, 16 moed practice, and seen were identified by practices as being too ill to

follow up 'figure⇓). &iomedical data were collected on 6!4 '%2.6() of those

eligible. &iomedical data was proided for 332 '%5.6() participants in theinterention arm and 2"2 '".3() in the control arm. ostal *uestionnaires were

completed by 536 '"3.1() of those eligible. The leel of return for the*uestionnaires was 2 '"5.3() for the interention arm and 23" '6%.5() for the

control arm. Table 1⇓ compares the baseline characteristics of those who were and

were not successfully followed up at three years. The group on whom three year

follow-up data were obtained were older 'G!.!1) and had a lower weight'G!.!!4), body mass inde 'G!.!!4), waist circumference '!.!!1), and

depression score '!.!!1). Ahen taing into account the treatment group, nointeractions between responders and group were found for these outcomes.

'lo6 of participants throu$h trial

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Table

7aseline characteristics of participants 6ith type - diabetes 6ho 6ere or 6ere

not follo6ed up at three years8 9alues are means :standard deviations; unless

stated other6ise

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7iomedical outcomes

Table 2⇓ shows the mean '5( confidence interal) change in biomedical

outcomes in the study groups at three years. +cross all biomedical outcomes

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improements were seen in both groups, with no significant differences betweengroups at three years. The primary outcome, b+1c leel, did not differ

significantly between the groups. The obsered difference between interentiongroups was 0!.!2 '5( confidence interal 0!.22 to !.1") after ad/usting for

baseline and clustering. The intraclass correlation for b+1c at three years was !.!2'5( confidence interal !.!! to !.!%).

Table -

Chan$es in biomedical outcomes at three years

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+t three years, no statistical difference was seen in 1! year coronary heart disease

or cardioascular ris '#nited $ingdom rospectie iabetes 7tudy) between theinterention and control groups, with reductions obsered in both groups 'table 2).

Lifestyle outcomes

+ significant difference in the proportion of non-smoers was seen in faour of the

interention arm at 12 months. This difference was not maintained at three years. 9o difference in the leel of physical actiity between the groups was seen at three

years 'G!.5%, table 3⇓).

Table .

Summary of lifestyle outcomes at three years

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+llness beliefs, depression, problem areas in diabetes, and

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of the duration of their diabetes and of their ability to affect the course of theirdisease. 9o difference was seen between the groups for depression, problem areas

in diabetes scores, and *uality of life at three years 'see supplementary file on bm/.com for *uality of life data).

Table /

Scores for illness beliefs and hospital an=iety and depression scale

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!ru$s

+t three years the number of people taing oral antidiabetic agents as monotherapyor dual therapy or those taing insulin did not differ significantly between the

groups 'table 5⇓).

Table 0

!ru$s used by participants 6ith type - diabetes

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!iscussion

+fter three years the impact of a single structured education interention deliered

to people with newly diagnosed type 2 diabetes mellitus was not sustained for biomedical and lifestyle outcomes, although some changes in illness beliefs werestill apparent.

reiously we reported that compared with baseline at 12 months b+1c leelsdecreased by 01.4( '5( confidence interals 01.6( to 01.2() in the

interention group and by 01.21( '01.4!( to 01.!2() in the controlgroup.3 The present study showed a small increase in b+1c leels from the 12

month data= howeer, oerall the decreases in both the interention group '01.32(,01.5"( to 01.!6() and the control group '0!.%1(, 01.!2( to 0!.5() were

sustained at three years.

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+lthough this is reassuring compared with the long term follow-up results of the#nited $ingdom rospectie iabetes 7tudy, which reported a 1( increase in

b+1c leel oer four years in a newly diagnosed cohort,/ this is not entirelyunepected in the contet of the recent improements to the management and

*uality of care of type 2 diabetes after the introduction of the *uality outcomesframewor.-4 + pragmatic, cluster randomised study undertaen in primary care,

+T@9->urope, was unable to detect cardioascular benefit of multifactorialtherapy compared with routine care in people with type 2 diabetes detected by

screening. This is thought to be at least in part attributable to changes to nationalguidelines during the follow-up period of the trial, resulting in allocated treatments

of the interention and control group becoming more similar..5 The clear benefitsof an interention aboe routine care has become increasingly difficult to show in a

setting where outcome measures are often successfully treated to target fromdiagnosis. oweer, other important aspects of diabetes management are not

currently captured or incentiised by current targets, including self managementsills and empowerment, which were ealuated in this study.-4

+ report of the best methods for ealuating diabetes education identified four eyoutcomes associated with optimal ad/ustment to liing with diabetes, which

comprised nowledge and understanding, self management, self determination, and psychological ad/ustment, two of which were assessed in this study.. The

significant improements to four of the fie illness beliefs were sustained at threeyears and indicate a greater understanding by the participants of their diabetes andof their ability to affect the course of their diabetes. +lthough participants from the

interention group belieed their diabetes to be more serious and were more lielyto agree that they would hae diabetes for life, this had not caused them greater

distress about their diabetes, as eidenced by responses to the problem areas indiabetes *uestionnaire. :urther research is re*uired to ascertain how to translate

these into faourable biomedical outcomes in the longer term.

7ince the launch of the >7?@9 programme, numerous studies hae aimed toimproe self management in people with type 2 diabetes. + recent meta-analysis

assessing the impact of self management interentions in people with type 2

diabetes published before 2!!" reported improements to glycaemic control in people who receied self management treatment, with a small adantage of an

interention with an educational approach.- The results of the >7?@9interention published in 2!!% were not included in the meta-analysis. @f the

studies included in the reiew, only eight reported follow-up results at greater than12 months.

The >7?@9 interention for people with newly diagnosed type 2 diabetes was

always intended to be included within an ongoing model of education and clinicalcare, integrating life long learning, care planning, and treatment optimisation.

oweer, a ey aspect of the study design was to show at what point any benefitsof interention begin to diminish. urrently, our group are deeloping and

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implementing the >7?@9 ongoing module to ealuate the long termeffectieness of an ongoing self management interention in people with type 2

diabetes. The findings of these studies will help to determine the optimal contacttime and fre*uency of education sessions re*uired to sustain improements to

clinical outcomes through self management. The >7?@9 interention is lielyto remain cost effectie as the cost effectieness analysis of the >7?@9

interention using 12 month data was based on the assumption that obseredlifestyle changes and smoing cessation would not be sustained without an

ongoing maintenance interention.-5 Ae hae shown that deliery of the>7?@9 interention at diagnosis is beneficial for psychosocial outcomes.

+lthough these benefits are important it remains uncertain at what stage, if eer, biomedical benefits emerge in people with newly diagnosed type 2 diabetes and

whether in the longer term a relation between the two translates into more effectieself management to maintain glycaemic control. articipants may need further

education and ongoing support to successfully manage their condition and toachiee improements to clinical outcomes and self management behaiours longterm.

Comparison 6ith other studies

>idence of the long term impact of structured education interentions in people

with diabetes is currently lacing. The dose ad/ustment for normal eating'+:9>) interention deliered as a single structured education programme to a

group of adults with type 1 diabetes showed clinically significant improements tob+1c leels without an increase in seere hypoglycaemia at two years..- Euality

of life and improements to b+1c leels were maintained at four years... Theauthors suggest that follow-up support for this population group may create

additional benefits by helping people to identify routines to better integrate thisregimen into their lies.

The epert patient education ersus routine treatment 'I->8T) programmereported significant improements to b+1c leel at 14 months '0!.6( % !.1() in a

population with established type 2 diabetes, although long term results hae not yet

been reported../ articipants of the I->8T programme had a mean duration of6." years, compared with our newly diagnosed cohort in whom additional benefitsof an education programme were hard to show when medical outcomes were

aggressiely and successfully targeted. +n additional dissimilarity is that the I->8T interention was deliered oer si sessions with participants receiing

double the contact time as those of the >7?@9 interention, which may confer additional benefits.

The rethin organisation to improe education and outcomes '8@?>@)interention was deliered in a secondary care clinic setting in taly as a

continuous education programme. ;ong term outcomes at four years hae reportedfaourable clinical, cognitie, and psychological outcomes in a cohort with

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established type 2 diabetes..0 The interention comprised one hour educationsessions deliered on a three monthly basis, whereas the >7?@9 module was

deliered as a single interention inoling si hours of contact time, with nofurther reinforcement of the messages deliered. The 8@?>@ interention implies

that an ongoing model of education and care can result in improements to clinicaloutcomes. oweer, further research is re*uired to ascertain whether these results

are replicable out of the talian secondary care clinical setting.

+ self management interention deliered in a primary care setting in 7weden

showed an ad/usted difference in b+1c leel of 1.3"( '!.!!1) at fie years between interention and control groups..1 The interention group receied 1!

group sessions, two hours long, oer a period of nine months. The interention didnot hae a curriculum or agenda, and whether the impressie study results can be

replicated has yet to be determined.

+s with all educational interentions, >7?@9 is a comple interention,

which maes it difficult to ascertain the actie components contributing to positieeffects of the interention..2 @ne aspect of the >7?@9 interention is goal

setting, where the participant chooses one part of their care to wor at. The relatiesuccess of this component, as with others, is currently unnown in the >7?@9

interention. + randomised controlled trial that ealuated the impact of goal settingin self management education in people with type 2 diabetes recently reported that

at 12 months statistically significant faourable differences in b+1cleels wereseen in the interention group..3

Stren$ths and limitations of the study

The original >7?@9 trial has seeral strengths, which hae been discussed atlength preiously.3 n brief, the trial had a robust cluster randomised design, with

reasonably well matched participants in the control and interention groups, andthe study was successful in minimising contamination between practices.

mportantly, the interention was designed for consistent reproducibility of trainingand had a relatiely low up-front training inestment, enabling implementation

across other sites. +ll educators participating in the interention were fully trainedand *uality assured, ensuring generalisability of the findings in other >7?@9

studies and out of the research setting.

7tatistical analyses for this study were undertaen using intention to treat analysis,

minimising bias in the reported findings. oweer, our study may hae beenunderpowered to detect improements in clinical outcomes and as a result some of

our findings may be prone to type 2 error. 8esponse rates of the study were higherthan epected after three years of follow-up, with collection of biomedical data

achieed by %3( of participants and *uestionnaire data by "!(, minimising

missing data and the effect this may hae had on the interpretation of the studyresults. This compares positiely with other self management education

http://www.bmj.com/content/344/bmj.e2333#ref-35http://www.bmj.com/content/344/bmj.e2333#ref-35http://www.bmj.com/content/344/bmj.e2333#ref-36http://www.bmj.com/content/344/bmj.e2333#ref-37http://www.bmj.com/content/344/bmj.e2333#ref-38http://www.bmj.com/content/344/bmj.e2333#ref-18http://www.bmj.com/content/344/bmj.e2333#ref-18http://www.bmj.com/content/344/bmj.e2333#ref-35http://www.bmj.com/content/344/bmj.e2333#ref-36http://www.bmj.com/content/344/bmj.e2333#ref-37http://www.bmj.com/content/344/bmj.e2333#ref-38http://www.bmj.com/content/344/bmj.e2333#ref-18

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interentions that obtained long term follow-up data from 63( to %5( of theoriginal participants... .0 .1 Those who were followed up at three years were

older, healthier, and less depressed at baseline than those who were not followedup. This selection bias should be considered when interpreting the results, although

importantly there was no interaction with interention group. +dditionally, missingdata on indiiduals may hae less impact in a cluster randomised trial than in an

indiidually randomised trial.

+ weaness of our study was lac of power to find differences in hard end points

and that significant differences in mortality or cardioascular eents were unlielyto be detected in this study. n reality, interention studies that report decreases in

cardioascular mortality and morbidity in people with type 2 diabetes re*uirelonger follow-up..4 /5 7tudies designed with sufficient power to detect differences

in these important outcomes will proide aluable information to shape the model

of future diabetes care. + non-response bias was detected in this study, withresponders being older, less oerweight 'according to body mass inde and waistcircumference), and reporting more depressie symptoms.

Conclusion

n a cohort of adults with newly diagnosed type 2 diabetes a single, si hourstructured programme in self management did not offer sustained benefits in

biomedical outcome measures and lifestyle outcomes at three years, but somechanges to illness beliefs were sustained. The results support a programme of an

ongoing model of education, although the optimum interal and contact time needsfurther ealuation. oweer, we recognise that additional support through

increased contact time and fre*uency may incur additional benefit throughimportant improements to biomedical outcomes, and further research to establish

this is needed. :uture studies need to incorporate a longer follow-up period togenerate understanding of interention effects oer time.

#hat is already $nown on this topic

•

The diabetes national serice framewor and 9> *uality standards promote structured education for all from diagnosis of diabetes

• #ntil now no studies hae ealuated the long term impact of attending an

education interention

#hat this study adds

• ifferences in biomedical and lifestyle outcomes at 12 months from a

structured group education programme for patients with newly diagnosed

type 2 diabetes were not sustained at three years, although illness beliefsremained significant

http://www.bmj.com/content/344/bmj.e2333#ref-33http://www.bmj.com/content/344/bmj.e2333#ref-33http://www.bmj.com/content/344/bmj.e2333#ref-35http://www.bmj.com/content/344/bmj.e2333#ref-36http://www.bmj.com/content/344/bmj.e2333#ref-39http://www.bmj.com/content/344/bmj.e2333#ref-40http://www.bmj.com/content/344/bmj.e2333#ref-33http://www.bmj.com/content/344/bmj.e2333#ref-35http://www.bmj.com/content/344/bmj.e2333#ref-36http://www.bmj.com/content/344/bmj.e2333#ref-39http://www.bmj.com/content/344/bmj.e2333#ref-40

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• The results support the model of an ongoing education programme, although

the optimum interal and contact time needs further ealuation

#otes

Cite this as> BMJ 2!12=344Ce2333

'ootnotes

• Ae than the 9ational nstitute for ealth 8esearch ollaboration for

;eadership in +pplied ealth 8esearch and areJ;eicestershire,

9orthamptonshire, and 8utland, and the &iomedical 8esearch #nit.

•

ontributorsC $$ was the principal inestigator of the three year follow-upstudy and drafted the paper. ;< analysed the data and drafted the paper. T7 was

inoled in the conception of the >7?@9 programme and reiewed the paper.?> was the pro/ect manager of the 12 months >7?@9 trial and reiewed the

paper. $8 collated the data. was senior researcher and collated data anddrafted the paper. : drafted the paper. ? was inoled in the design, analysis,

and interpretation of the data. 7 was inoled in the conception of the>7?@9 programme and reiewed the paper. ?B was the principal

inestigator for the >7?@9 trial, designed the trial, and reiewed the paper.

• :undingC This study was funded by a grant from iabetes #$ secured by a

/oint team from ;eicester #niersity and the #niersity ospitals of ;eicester 97 Trust. The writing of the report and the decision to submit the article for

publication was entirely independent of the funder. The study funder had no inputinto the study design or analysis, nor the interpretation of data.

• ompeting interestsC +ll authors hae completed the ?B> uniform

disclosure form at www.icm/e.orgKcoiLdisclosure.pdf 'aailable on re*uest fromthe corresponding author) and declareC no support from any company for the

submitted wor= no financial relationships with any companies that might hae aninterest in the submitted wor in the preious three years= no other relationships or

actiities that could appear to hae influenced the submitted wor.

• >thical approalC This study was approed by the untingdon local research

ethics committee and was carried out in accordance with the principles of the 16

elsini declaration.

• ata sharingC 9o additional data aailable.

This is an open-access article distributed under the terms of the reatie ommons

+ttribution 9on-commercial ;icense, which permits use, distribution, and

reproduction in any medium, proided the original wor is properly cited, the use

http://www.icmje.org/coi_disclosure.pdfhttp://www.icmje.org/coi_disclosure.pdf

8/19/2019 Blok 22 Tugas

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is non commercial and is otherwise in compliance with the license.7eeChttpCKKcreatiecommons.orgKlicensesKby-ncK2.!K and httpCKKcreatiecommons.or

gKlicensesKby-ncK2.!Klegalcode .

%eferences1. ↵

?assi-&enedetti ?. The cost of diabetes type ii in >uropeC the @>-2

study. iabetologia 2!!2=/0C71-4.

@pen#rlross8ef?edlineAeb of 7cience

2. ↵

Tapp 8, 7haw B, Mimmet , eds. omplications of diabetes. nC nternational diabetes

federation, ed. iabetes atlas. 2nd ed.nternational iabetes :ederation, 2!!3.

3. ↵

9orris 7, 9ichols , aspersen , ngelgau ?, Bac ;. ncreasing diabetes

self management education in community settings. + systematic reiew.+m B re

?ed2!!2=--C3-66.


4. ↵

#$ rospectie iabetes 7tudy

8/19/2019 Blok 22 Tugas

15/22

". ↵

9ational nstitute for ealth and linical >cellence.

8/19/2019 Blok 22 Tugas

16/22

15. ↵

9ational nstitute for ealth and linical >cellence 7?@9) programme for people with newly

diagnosed type 2 diabetesC cluster randomised controlled trial. &?B 2!!%=..1C41-5.

@pen#rl+bstractK:8>> :ull Tet

1. ↵

$hunti $, 7inner T, eller 7, arey ?, allosso , aies ?. &iomedical, lifestyle

and psychosocial characteristics of people newly diagnosed with type 2 diabetesC

baseline data from the >7?@9 randomiFed controlled trial. iabet

?ed2!!%=-0C1454-61.


2!. ↵

8/19/2019 Blok 22 Tugas

17/22

?inet ;, ?oller 7, Hach A, Aagner ;, enrisen B. ?ediating the effect of self-care

management interention in type 2 diabetesC a meta-analysis of 4" randomised

controlled trials. atient >duc ouns2!1!=35C2-41.


22. ↵

;eenthal , ?eyer , 9erenF . The common-sense representation of illness danger.

ontributions to medical psychology. ergamon, 1%!.

23. ↵

haien 7, Aood A, >agly +. rinciples of persuasion. nC iggih >$+, ed. 7ocial

psychologyC handboo of basic principles. > :ull Tet

26. ↵

+nderson 8. atient empowerment and the traditional medical model. + case of

irreconcilable differencesN iabetes are15=3C412-5.

@pen#rl:8>> :ull Tet

2". ↵

7inner T, owells ;, dgar $, ?c>illy +, Bohansson +. eelopment,

reliability and alidity of the diabetes illness representations *uestionnaireC four studies

with adolescents. iabet ?ed2!!3=-5C2%3-.


2%. ↵

Aelch

8/19/2019 Blok 22 Tugas

18/22

@pen#rl+bstractK:8>> :ull Tet

2. ↵

+lshamsan 8, ?illett , ?a/eed +, $hunti $. as pay for performance improed the

management of diabetes in the #nited $ingdomN rimary are iabetes2!1!=/C"3-%.

@pen#rlross8ef?edline

3!. ↵

ffect of early intensie multifactorial therapy on 5-year cardioascular outcomes in

indiiduals with type 2 diabetes detected by screening '+T@9->urope)C a cluster-

randomised trial. ;ancet2!11=.23C156-6".


31. ↵

>genmann , olagiuri 8. @utcomes and indicators for diabetes educationJa national

consensus position. iabetes +ustralia, 2!!".

32. ↵

The +:9> 7tudy ating) structured education to promote intensie insulin therapy in adults with

sub-optimally controlled type 1 diabetes. iabet 8es lin ract2!1!=34C22-.

@pen#rlross8ef?edline

34. ↵

eain T, ade B, Ailliams 8, 8T rogramme maes a difference. iabet ?ed2!!6=-.C44-54.


35. ↵

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Trento ?,

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>fetiitas pendidian diabetes dan program

mana/emen diri ' >7?@9 ) bagi orang-orang yang

baru didiagnosis diabetes melitus tipe 2 C tiga tahun

tinda lan/ut dari cluster terontrol secara aca percobaan dalam perawatan primer

Translate abstra

Tu/uanC

#ntu menguur apaah manfaat dari program pendidian dan mana/emen diriterstrutur tunggal bagi penderita diabetes melitus tipe 2 yang baru terdiagnosis

dipertahanan pada tiga tahun .

esainC

Tiga tahun tinda lan/ut dari cluster multisenter aca terontrol dalam

perawatan primer , dengan pengacaan pada tingat prate .

engaturan 2!" prate umum di 13 loasi perawatan primer di nggris .

eserta "31 dari %24 peserta termasu dalam persidangan asli yang memenuhi

syarat untu tinda lan/ut . ata biomedis diumpulan pada 6!4 ' %2,6 ( ) dan

uesioner data pada 513 ' "!,1 ( ) peserta .nterensiC

rogram pendidian elompo terstrutur selama enam /am disampaian

dalam masyaraat dengan dua pendidi profesional esehatan yang terlatih

dibandingan dengan perawatan biasa .

asil penguuran utama asil utama yang tergliasi hemoglobin ' b+1c )

tingat . asil seunder adalah teanan darah , berat badan , tingat lipid darah,

status meroo , atiitas fisi , ualitas hidup , eyainan tentang penyait ,

depresi , dampa emosional dari diabetes , dan penggunaan naroba di tiga

tahun .asil C

adar b+1c pada tiga tahun mengalami penurunan pada edua elompo .

7etelah disesuaian dengan dasar dan cluster perbedaannya tida signifian

' perbedaan -!,!2 , 5( interal epercayaan -!,22 !,1" ) . $elompo-

elompo tida berbeda untu hasil biomedis dan gaya hidup lainnya dan

penggunaan naroba . ?anfaat yang signifian pada elompo interensi di

empat dari lima eyainan esehatan terlihat pada 12 bulan dipertahanan pada

tiga tahun ' !,!1 ) . 7or depresi dan ualitas hidup tida berbeda pada tiga

tahun .

$esimpulanC

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7ebuah program tunggal untu orang yang baru didiagnosis diabetes mellitus

tipe 2 tida menun/uan perbedaan hasil biomedis atau gaya hidup di tiga

tahun mesipun ada yang berelan/utan perbaian di beberapa eyainan

penyait .

?ethod

7idang metode penelitian , interensi , dan hasil pada 12 bulan telah dilaporan secara rinci

preiously.1% 1 7ingatnya, cluster uat aca terontrol dilauan untu menilai efetiitas

program pendidian mana/emen diri terstrutur yang ter/adi di 13 loasi perawatan primer

' 2!" prate ) di nggris dan 7otlandia . engacaan berlangsung di tingat prate umum

untu meminimalan ontaminasi antara peserta , dengan stratifiasi menurut status pelatihan

dan /enis ontra dengan organisasi perawatan primer ' #mum elayanan $esehatan atau

elayanan $esehatan ribadi ) . engacaan dilauan secara independen di #niersitas

7heffield menggunaan +ca ;og. ada setiap situs oordinator loal mengawasi sidang ,mererut dan melatih prate , dan mempertahanan onta dengan staf prate . $iner/a

situs dan oordinator loal dimonitor secara teratur , dengan masing-masing situs yang

menerima un/ungan sebelum sidang dan minimal satu un/ungan monitoring per tahun . 7taf

prate mengirim data biomedis e oordinator loal untu menerusan e pusat oordinasi

pusat.

ndiidu diru/u dalam watu enam minggu dari diagnosis penelitian, dengan orang-orang

dalam elompo interensi menghadiri program pendidian terstrutur dalam watu 12

minggu diagnosis . eserta sidang asli dieluaran /ia merea berusia urang dari 1% tahun ,

memilii masalah esehatan mental yang berat dan abadi , tida terutama bertanggung /awab

untu perawatan merea sendiri , tida dapat berpartisipasi dalam program elompo

' misalnya , yang tinggal di rumah atau tida mampu beromuniasi dalam bahasa nggris ) ,atau berpartisipasi dalam studi penelitian lain . 8erutmen berlangsung antara @tober 2!!4

dan Banuari 2!!6. 7etiap orang yang setu/u untu bergabung dengan pengadilan asli

memenuhi syarat untu tinda lan/ut pada tiga tahun ecuali merea telah ditari selama

persidangan atau prate merea memberitahu ami bahwa merea tida lagi saat latihan

atau bahwa itu aan pantas untu menghubungi merea ' misalnya , arena penyait serius ) .

8esult and analysis

#ntu penelitian asli uuran sampel dihitung berdasaran standar deiasi tingat b+1c dari

2 ( , orelasi intraclass !,!5 , dan rata-rata 1% peserta per prate . $ami menghitung bahwa

ami membutuhan 315 peserta per elompo studi untu mendetesi perbedaan linis yangrelean di tingat b+1c dari 1 ( pada 12 bulan , dengan euatan ! ( pada tingat

signifiansi 5 ( . engan asumsi egagalan untu menyetu/ui tarif 2! ( ' tida memenuhi

syarat serta menola berpartisipasi ) dan tingat putus seolah dari 2! ( , 1!!! peserta ' 5!!

di setiap lengan ) perlu diru/u .

+nalisis statisti dilauan dengan niat untu mengobati . Hariabel ontinu diberian sebagai

sarana dan standar deiasi atau median dan rentang interuartil dan ariabel ategori sebagai

/umlah dan persentase . #ntu menyesuaian laster ami menggunaan persamaan estimasi

umum yang uat dengan strutur orelasi tuar . #ntu hasil biner ami menggunaan lin

logit dengan distribusi binomial untu hasilnya , dan untu hasil yang berelan/utan ami

menggunaan lin identitas dengan distribusi normal . enyesuaian untu nilai dasar dibuat

dalam semua model 'terlepas dari masalah daerah dalam sor diabetes , yang tida tercatat

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pada awal seperti itu tida pantas bagi peserta yang baru didiagnosis diabetes tipe 2 ) . $ami

berasumsi data yang aan hilang secara aca dan merea tida diganti atau diperhitungan .

7ignifiansi statisti yang ditetapan sebesar 5 ( , tanpa penyesuaian untu beberapa

pengu/ian , mesipun semua nilai ditafsiran sesuai dengan pola hasil . 7emua analisis

dilauan di 7tata ' ersi 1!.! ) .

hasilari %24 orang yang setu/u untu mengambil bagian dari 2!" prate umum ' 3%" ontrol

dan 43" interensi ) e pengadilan asli, "43 ' !,2 ( ) yang memenuhi syarat untu tinda

lan/ut pada tiga tahun . ari merea tida memenuhi syarat , 26 meninggal, 44 menari diri

dari penelitian , 16 prate pindah , dan tu/uh diidentifiasi oleh prate sebagai terlalu sait

untu menindalan/uti ' figure⇓ ) . ata biomedis diumpulan pada 6!4 ' %2,6 ( ) dari

merea yang memenuhi syarat . ata biomedis diberian untu 332 ' %5,6 ( ) peserta dalam

elompo interensi dan 2"2 ' ",3 ( ) pada elompo ontrol . $uesioner pos diselesaian

oleh 536 ' "3,1 ( ) dari merea yang memenuhi syarat . Tingat pengembalian uesioner

adalah 2 ' "5,3 ( ) untu elompo interensi dan 23" ' 6%,5 ( ) untu elompo

ontrol . Tabel 1⇓ membandingan arateristi dasar dari merea yang berhasil dan tida

ditindalan/uti pada tiga tahun . $elompo ini pada siapa tiga tahun data tinda lan/utdiperoleh lebih tua ' G !,!1 ) dan memilii berat badan lebih rendah ' G !,!!4 ) , indes

massa tubuh ' G !,!!4 ) , lingar pinggang ' !,!!1 ) , dan sor depresi ' !,!!1 ) .

$etia mempertimbangan elompo perlauan , tida ada interasi antara responden dan

elompo yang ditemuan untu hasil ini .

blok 22 tugas

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