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  Collegian(2014) 21 ,   43—51  Available   online   at   www.sciencedirect.com  journalhomepage:www.elsevier.com/locate/coll Cluster   randomised   controlled   trial:   Educationalself-care   intervention   with   older   Taiwanese   patientswith   Type   2   diabetes   mellitus——Impact   on   bloodglucose   levels   and   diabetic   complications Ying-Hua   Chao a , b ,   Kim   Usher b , ∗ ,   Petra   G.   Buettner c ,   Colin   Holmes d a Department   of    Nursing,   Yuanpei   University,   Taiwan b School   of    Nursing,   Midwifery    and    Nutrition,    James   Cook   University,   Cairns,   PO   Box    6811,   Cairns,   QLD   4870,    Australia c School   of    Public   Health,   Tropical   Medicine   and    Rehabilitation   Sciences,    James   Cook   University,   Townsville,    Australia d School   of    Nursing,   Midwifery    and    Nutrition,    James   Cook   University,   Townsville,    Australia Received   14   June   2012;   received   in   revised   form   12   December   2012;   accepted   17   December   2012 KEYWORDS Type   2   diabetesmellitus;Taiwan;Nursing;Educationalintervention;Experimental   study;Randomisedcontrolled   trial Summary  Aims:   To   investigate   whether   self    care   behaviours,   medical   outcomes   and   quality   of    life   of    Tai-waneseelderly   with   Type   2   diabetes   mellitus   (DM)   can   be   improved   by   delivery   of    an   educationalhealthcare   package. Background:   DM   is   a   major   health   problem   in   developed   and   developing   countries,   with   olderadultsconstituting   about   half    of    the   diabetic   population.   Type   2   DM   is   the   most   rapidly   increasingchronicdisease   in   Taiwan. Methods:   During   2005   and   2006,   Taiwanese   elderly   with   Type   2   DM   ( n   =   500)   were   randomlyallocated   to   either   an   intervention   or   control   group.   Data   collection   using   validated   instrumentsoccurred   at   baseline   and   6   months   follow-up.   Main   outcome   measures   were   blood   glucose   levelsanddiabetic   complications. Results:   At   baseline,   88.4%   participants   in   the   control   and   78.8%   in   the   experimental   grouphada   blood   glucose   level   above   normal   range   (  p   =   0.076);   respective   results   at   6   months   were92.4%for   the   control   group   and   60.4%   for   the   experimental   group   (  p   <   0.001).   The   multivariateadjustedresult   showed   that   the   intervention   group   was   11.1   times   less   likely   to   have   bloodglucoselevels   above   normal   (  p   =   0.002)   at   6   months   follow-up   compared   to   the   control   group.Occurrence   of    complications   was   significantly   fewer   in   the   intervention   group   at   baseline   andat6   month   follow-up   compared   to   the   control   group   (baseline:   42.0%   versus   82.1%,    p   =   0.003;6month   follow-up:   48.4%   versus   87.0%;    p   =   0.006). ∗ Correspondingauthor.Tel.:+61740421391;fax:+61740421590. E-mailaddresses: chaoyh211@yahoo.com.tw(Y.-H.Chao),kim.usher@jcu.edu.au(K.Usher),petra.buttner@jcu.edu.au(P.G.Buettner), colin.holmes1@jcu.edu.au(C.Holmes). 1322-7696/$—seefrontmatter©2013AustralianCollegeofNursingLtd.PublishedbyElsevierLtd. http://dx.doi.org/10.1016/j.colegn.2012.12.006  44   Y.-H.   Chao   et   al. Conclusion:   Although   overall   occurrence   of    complications   remained   unchanged,   the   educationalhealthcare   package   specifically   developed   for   Taiwanese   elderly   with   Type   2   DM   improved   bloodglucoselevels.©   2013   Australian   College   of    Nursing   Ltd.   Published   by   Elsevier   Ltd. Introduction Type   2   diabetes   mellitus   (DM)   is   a   metabolic   disorder   char-acterised   by   chronic   hyperglycemia   with   disturbances   of the   carbohydrate,   fat   and   protein   metabolism.   It   is   asso-ciated   with   reduced   life   expectancy,   significant   morbiditydue   to   specific   DM   related   microvascular   complications,increased   risk   of    macrovascular   complications   (ischaemicheart   disease,   stroke   and   peripheral   vascular   disease),   anddiminished   quality   of    life   (WHO,   2006).   Poor   glycemic   con-trol   in   persons   with   Type   2   DM   mellitus   has   other   seriousconsequences   related   to   cognitive   function,   psychologicalstatus,   for   example   depression,   anxiety   and   stress,   andthe   likelihood   of    increased   medical   complications   such   asretinopathy,   renal   failure,   neuropathy   with   the   risk   of    ampu-tation,   cardiovascular   disease,   mortality,   and   increasedmedical   costs   (Wangberg,   2008). Background DM   is   now   recognised   as   a   major   health   problem   in   devel-oped   and   developing   countries   with   approximately   1   in   20deaths   attributable   to   the   disease   (WHO,   2008).   RecentWHO   Global   Burden   of    Disease   estimates   predict   that   theworldwide   burden   in   adults   to   be   around   366   million   by   theyear   2030,   with   approximately   two   thirds   of    those   personsexpected   to   live   in   developing   countries   (WHO,   2006).   DM   isthe   most   rapidly   increasing   disease   in   Taiwan   (Chang,   2003)and   it   is   expected   that   the   number   of    people   with   DM   inTaiwan   will   increase   to   300   million   by   the   year   2025   (Chouet   al.,   2002).   Further,   people   living   in   the   rural   areas   of Taiwan   have   been   found   to   have   a   higher   likelihood   of    dia-betes,   which   may   be   accounted   for   in   some   way   by   thehigher   numbers   of    Absrcinal   people   living   in   those   areas(Chen   et   al.,   2006).   World-wide,   older   adults   constituteabout   one-half    of    the   diabetic   population.   In   this   age   groupDM   is   a   serious   disease   linked   to   a   higher   mortality   rate   andshorter   life   expectancy,   mostly   due   to   increased   atheroscle-rotic   complications   (Wandell   and   Tovi,   2000).   The   trend   issimilar   in   Taiwan,   especially   in   rural   areas   (WHO,   2006).Many   people   with   DM   struggle   to   adhere   to   recommendedprotocols   of    self-care   and   blood   glucose   managementand   thus   risk   the   development   of    harmful   complications(Diabetes   Prevention   Programme   Research   Group,   2002;Huang   et   al.,   2004).   The   United   Kingdom   ProspectiveDiabetes   Study   (UKPDS),   a   randomised,   prospective,   mul-ticentre   trial,   indicated   that   improved   glucose   control   inpatients   with   newly   diagnosed   Type   2   diabetes   mellitusgreatly   reduces   the   risk   of    clinically   evident   microvascularcomplications   (Holman,   Sanjoy,   bethel,   Neil,   &   Matthews,2008).It   has   been   well   recognised   that   in   general,   between   50%and   80%   of    people   living   with   DM   have   deficits   in   knowledgeand   self-care   skills   (Clement,   1995).   As   a   result,   the   healtheducation   model   (HEM)   was   used   as   the   theoretical   basis   forthe   study   was   based   on   the   revised   pender   health   promotionmodel   (RHPM)   (Pender,   Caroly,   &   Murdargh,   2006).   Improvingdiabetic   patient   knowledge   and   changing   attitudes   to   self-care   is   one   way   to   work   towards   achieving   better   outcomesfor   people   with   diabetes.   The   model   recognises   that   forpatients   to   be   empowered   in   self-care,   health   care   providersmust   provide   the   information   and   skills   required   for   change.Therefore,   a   specially   designed   education   programme   suitedto   the   needs   of    elderly   Taiwanese   rural   dwellers   with   dia-betes   was   developed. Thestudy Aim The   aim   of    the   present   cluster   randomised   trial   was   to   inves-tigate   the   effects   of    an   educational   intervention   programmefor   Taiwanese   elderly   with   Type   2   DM,   many   of    whom   havelow   levels   of    literacy,   on   blood   glucose   levels   and   DM   com-plication   rates.The   study   addressed   two   main   hypotheses   involvingthe   following   two   outcome   variables:   (1)   percent   of patients   with   a   well-controlled   blood   glucose   level   imply-ing   to   have   a   blood   glucose   level   in   normal   range   (AC:70—110   mg/dl   or   PC:   90—140   mg/dl)   and   (2)   percent   of patients   with   positive   markers   for   DM   complications.   Mark-ers   considered   were   serum   creatinine   (normal   range:0.6—1.5   mg/dl),   urine   analysis   (normal:   protein   and   glu-cose   both   zero),   microalbumin   (normal:   less   than   30   mg),cholesterol   (normal   range:   130—225   mg/dl),   triglyceride(normal   range:   50—130   mg/dl),   blood   pressure   (normalrange:   120/80   mmHg,   systolic   phase   is   120   mmHg   and   dia-stolic   phase   80   mmHg   in   adult),   and   cataract   or   retinopathypresent.   Both   outcome   variables   were   dichotomised.   Rangesfor   blood   markers   were   set   at   current   country   levels   at   thetime   of    the   study. Design The   present   cluster   randomised   controlled   trial   with   follow-up   after   3   and   6   months   was   conducted   in   central   andnorthern   Taiwan   between   2005   and   2006.   The   study   wasapproved   by   the   relevant   human   ethics   committees. Study   protocol Letters   describing   the   study   and   seeking   permission   forthe   investigators   to   phone   the   potential   participants   weremailed   from   the   participating   health   facilities   to   personswho   met   the   sampling   inclusion   criteria.   Each   letter   con-tained   a   self-addressed   return   envelope   allowing   interestedpersons   to   send   back   the   signed   consent   form.   Baseline   ques-tionnaires   were   mailed,   and   were   either   returned   by   mailafter   completion   ( n   =   35)   or   were   completed   during   a   face-to-face   interview   with   the   researchers   in   case   participants  Type   2   diabetes   mellitus——Impact   on   blood   glucose   levels   and   diabetic   complications   45requested   help   ( n   =   465).   Follow-up   questionnaires   werehanded   out   to   the   participants   during   their   three   monthlymedical   check-up   at   the   health   care   facilities.   Again,   mostquestionnaires   were   completed   during   a   face-to-face   inter-view   with   the   local   nurse.   There   were   ten   nurses   involvedin   the   study   and   these   nurses   were   previously   trained   bythe   researchers   to   ensure   consistency   in   the   data   collectionprocess. Intervention Both   intervention   and   control   participants   received   aspecially   designed   information   booklet   on   diabetes.   Partic-ipants   in   the   intervention   group   were   additionally   askedto   attend   a   1   h   diabetes   education   session   every   week   forthree   weeks.   In   the   first   week,   patients   acquired   generalinformation   about   DM   (introduction   to   diabetes,   signs   andsymptoms,   treatments,   hyperglycemia   and   hypoglycemia,and   complications).   In   the   second   week,   patients   werefamiliarised   with   specific   dietary   suggestions   (diabetes   andmeal   planning:   a   healthy   diet,   six   food   groups,   how   much   isa   serving   of    starch,   what   are   healthy   ways   to   eat   starches,how   much   to   eat   each   day   and   how   to   control   body   weight).In   the   third   week   patients   were   educated   about   the   self-carerequirements   related   to   DM   (home   care   of    diabetes:   exerciseplan,   medicine   management,   self-monitoring   of    blood   glu-cose,   foot   and   wound   care,   preparing   to   travel   with   diabetesand   introduction   to   DM   support   systems   in   Taiwan).   Theinformation   presented   was   based   on   available   and   valid   edu-cational   material   about   DM.   The   educational   material   wasdelivered   in   several   ways   including   formal   lecturing,   roleplay,   as   well   as   practice   and   experience   sharing   to   enhancethe   learning   ability   of    older   people.   All   educational   interven-tions   were   delivered   within   the   settings   of    the   participatinghealth   care   facilities.   The   educational   interventions   weredelivered   to   six   groups   of    participants   ranging   between   25and   70   in   size. Sample/participants Sample   size Sample   sizes   of    113   participants   were   required   per   group   todetect   a   difference   of    20%   between   intervention   and   con-trol   group   (adjusted   for   two   tests;   Chi-square   test;   power   inexcess   of    80%;   significance   level   5%).   The   sample   size   wasadjusted   for   the   cluster   sampling   approach   (design   effectestimated   to   be   2)   and   for   losses   to   follow-up   (10%).   A   sam-ple   size   of    250   participants   per   group   was   the   final   target. Participating   centres A   total   of    30   health   care   facilities   (20   randomly   selectedlocal   health   care   centres,   five   private   clinics   and   fiveregional   hospitals)   listed   with   the   non-governmental   Dia-betes   Shared   Care   Networks   of    Taiwan   were   approachedfor   collaboration   and   12   agreed   (6   local   health   care   cen-tres,   two   private   clinics   and   four   regional   hospitals).   These12   health   care   facilities   became   the   randomised   clusters.Health   care   facilities   that   declined   to   participate   did   sobecause   of    administrative   requirements   which   could   not   bemet   by   the   researcher   within   the   timeframe   of    the   study.Four   physicians,   10   nurses,   six   staff    from   the   Bureau   of    Pub-lic   Health   of    Hsinchu   City,   and   two   dieticians   collaboratedin   the   study. Participants All   patients   with   Type   2   DM   mellitus   at   the   12   participat-ing   health   care   services   recorded   between   2004   and   2005were   considered   for   participation.   Patients   who   (1)   were   50years   or   older;   (2)   were   diagnosed   as   having   Type   2   DM   melli-tus   (Taiwan   ICD-9   code   250)   or   had   poor   blood   sugar   control(more   than   140   mg/dl/AC   or   more   than   200   mg/dl/PC)   forthree   months;   (3)   had   been   treated   in   the   clinic   for   morethan   three   months;   (4)   had   functional   cognitive-mental   sta-tus   and   could   express   personal   perception;   (5)   had   no   seriousdisease   or   diabetic   conditions   that   may   confound   diabeticcontrol   or   HbA1c   value   such   as   acute   infections,   surgery,renal   disease,   liver   dysfunction,   or   low   haemoglobin;   and(6)   spoke   and   understood   Mandarin   or   Taiwanese   language,were   invited   to   participate.Patients   diagnosed   with   a   cerebral   vascular   accident,end-stage-renal   disease,   and/or   amputations   of    both   legswere   excluded.   Originally,   560   patients   of    the   participatinghealth   care   facilities   were   considered   eligible.   In   total   40participants   were   excluded,   including   two   persons   who   didnot   meet   the   inclusion   criteria   and   38   persons   who   declinedto   participate   (Fig.   1).   A   total   of    235   participants   in   theintervention   group   and   250   participants   in   the   control   groupcompleted   the   follow   up   questionnaire   at   6   months. Data   collection Validity   and   reliability All   participants   were   asked   to   complete   a   comprehensivequestionnaire   at   baseline   and   at   three   and   six   months   of follow-up.   The   questionnaire   included:   (1)   demographic   andsocio-economic   data   as   well   as   data   on   the   health   statusby   adapting   the   ‘‘Diabetes   personal   data   sheet’’   proposedby   Chang   (2003)   with   permission;   (2)   The   ‘‘RAND   SocialHealth   Battery’’   a   validated   questionnaire   that   measuresthe   social   interaction   and   social   supports   of    the   partici-pant   (Abdulrehman   and   De   Luca,   2001).   The   scale   covershome   and   family,   friendships,   and   social   and   communitylife   using   both   open-ended   and   forced—choice   questions;(3)   Questions   on   social   services   were   adapted   from   the‘‘Structured   Interview   Guide’’   (Ervin,   2004).   The   ques-tions   focused   on   the   family’s   experiences   of    using   servicesfrom   various   agencies   and   social   services;   (4)   The   ‘‘HealthPerceptions   Questionnaire’’   (Ware,   1976)   is   a   validated   self-report   instrument   that   records   perceptions   of    past,   present,and   future   health,   resistance   to   illness,   and   attitude   towardssickness.   The   questionnaire   contains   33   items   which   form   sixsubscales:   current   health   (nine   items),   prior   health   (threeitems),   health   outlook   (four   items),   resistance   to   illness(four   items),   health   worry/concern   (five   items),   sickness   ori-entation   (two   items),   and   6   other   uncategorised   items;   (5)Summary   of    diabetes   self-care   activities   (SDSCA)   consistingof    11   items   and   14   additional   questions.   The   dimensions   of SDSCA   are   diet   (4   items),   exercise   (2   items),   self-monitoringof    blood   glucose   (2   items),   foot   care   (2   items)   and   smok-ing   termination   (1   item)   (Anderson   and   Svardsudd,   1995;Toobert   and   Glasgow,   1994;   Wen,   Shepherd,   &   Parchman,2004).   The   validated   version   of    SDSCA   used   included   ques-tions   about   self-care   recommendations   received   from   healthcare   providers   and   medication   related   questions;   and   (6)The   World   Health   Organisation   Quality   of    Life   Taiwan   Brief   46   Y.-H.   Chao   et   al. Assessed for eligibility: n = 560 patients from 12 health care facilitiesCluster randomisation: n = 520 patients from 12 health care facilitiesExcluded: n = 2 not meeting inclusion criteria; n = 38 refused to participateAllocated to intervention group: n = 260 from 6 health care facilities N = 241 received allocated intervention [19 patientsrefused to further participate, saying they were too busy]Allocated to control group: n = 260 from 6 health care facilities N = 259 received allocated control [1 patient had incomplete medical records]Lost to follow-up (6 months): n = 6 [6 patients refused to further participate, indicating they were too busy]Lost to follow-up (6 months): n = 9 [2 patients refused to further participate, indicating they were too busy; 7 patients had died]Analysed: n= 235Analysed: n = 250 Figure   1   Flow   chart   of    Taiwanese   patients   with   Type   2   diabetes   mellitus   considered   for   participation   in   the   educational   inter-ventionstudy. version   (WHOQOL-BREF-TAIWAN)   was   used   in   this   study   tomeasure   patients’   subjective   perception   of    quality   of    life.The   validated   questionnaire   consists   of    26   srcinal   itemsand   two   additional   items   related   to   Taiwanese   culture   (Yao,Chung,   Yu,   &   Wang,   2002).   A   panel   of    expert   professionalswho   specialised   in   DM   examined   each   item   in   the   surveyindependently:   physicians,   8   public   health   leaders,   dieti-tians,   and   a   counsellor   (nurse)   who   had   extensive   experiencein   providing   DM   education   to   patients.   The   panel   examinedboth   the   contents   and   the   responses. Clinical   outcome   measures The   clinical   data   collected   from   the   participants’   medicalrecords   included   diabetes-related   and   nondiabetes-relatedco-morbidities,   results   from   ophthalmoscope   examina-tions,   blood   tests   for   cholesterol,   triglyceride,   glycosylatedhaemoglobin   and   nephropathy   assessment   such   as   urineacid,   blood   urea   nitrogen   (BUN),   and   serum   creatinine.Results   of    urinary   tests   for   micro   albumin,   urine   proteinand   urine   glucose   were   noted.   Blood   glucose   levels   weremeasured   either   by   the   researchers   or   by   staff    of    the   partici-pating   health   care   facilities   at   baseline   and   again   after   threeand   six   months   during   routine   medical   check-up.   Elevatedlevels   of    creatinine,   urine   analysis   (protein   and   glucoselevel),   micro   albumin,   cholesterol,   triglyceride,   and   bloodpressure,   as   well   as   the   occurrence   of    cataract   or   retinopa-thy   were   recorded   as   DM   complications. Pilot   study During   December   2005   to   January   2006   a   pilot   study   intwo   small   communities   in   Taiwan,   Hsinchu   and   Taichung,was   conducted.   The   purpose   of    the   pilot   study   was   toexplore   how   diabetes   researchers   delivered   diabetes   careprogrammes   in   Taiwan   and   was   used   to   select   variables   forthe   main   study   and   to   inform   study   procedures.   In   addition,as   the   validated   questionnaires   found   in   the   literature   werenot   adaptable   directly   to   the   sample   of    the   current   study,the   scales   were   modified   for   use   during   this   phase   of    theresearch.   For   the   pilot   study,   a   convenience   sample   of    15patients   50   years   or   older   with   Type   2   DM   was   recruited.   Fourindividual   interviews   with   professionals   (two   physicians   andtwo   dietitians)   were   conducted   to   explore   their   views   aboutthe   quality   of    diabetes   care   in   Northern   Taiwan.   Two   patientfocus   groups   (eight   from   the   experimental   and   seven   fromthe   control   group)   were   conducted   to   explore   their   percep-tion   about   diabetes   care.   The   participants   of    the   pilot   studywere   followed-up   for   4   weeks.   The   pilot   study   identifiedspecific   problems   and   suggestions   reported   by   healthcareprofessionals   and   patients.   These   qualitative   findings   high-lighted   the   importance   of    taking   into   account   communityhealth   and   social   support   as   well   as   the   structure   and   pro-cess   of    health   care.   These   findings   guided   the   selection   of variables   for   the   main   study. Ethical   considerations The   study   was   approved   by   the   relevant   human   ethics   com-mittees   and   participation   was   voluntary. Data   analysis Data   were   analysed   using   the   Statistical   Package   for   SocialSciences   (SPSS)   version   14.0   and   STATA   for   Windows,   release
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