title: Effectiveness of the EMPOWER-PAR Intervention in Improving Clinical Outcomes of Type 2 Diabetes Mellitus in Primary Care: A Pragmatic Cluster Randomised Controlled Trial.
abstract: The chronic care model was proven effective in improving clinical outcomes of diabetes in developed countries. However, evidence in developing countries is scarce. The objective of this study was to evaluate the effectiveness of EMPOWER-PAR intervention (based on the chronic care model) in improving clinical outcomes for type 2 diabetes mellitus using readily available resources in the Malaysian public primary care setting.
  
  
  
  This was a pragmatic, cluster-randomised, parallel, matched pair, controlled trial using participatory action research approach, conducted in 10 public primary care clinics in Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care. Patients who fulfilled the criteria were recruited over a 2-week period by each clinic. The obligatory intervention components were designed based on four elements of the chronic care model i.e. healthcare organisation, delivery system design, self-management support and decision support. The primary outcome was the change in the proportion of patients achieving HbA1c < 6.5%. Secondary outcomes were the change in proportion of patients achieving targets for blood pressure, lipid profile, body mass index and waist circumference. Intention to treat analysis was performed for all outcome measures. A generalised estimating equation method was used to account for baseline differences and clustering effect.
  
  
  
  A total of 888 type 2 diabetes mellitus patients were recruited at baseline (intervention: 471 vs.
  
  
  
  417). At 1-year, 96.6 and 97.8% of patients in the intervention and control groups completed the study, respectively. The baseline demographic and clinical characteristics of both groups were comparable. The change in the proportion of patients achieving HbA1c target was significantly higher in the intervention compared to the control group (intervention: 3.0% vs.
  
  
  
  -4.1%, P < 0.002). Patients who received the EMPOWER-PAR intervention were twice more likely to achieve HbA1c target compared to those in the control group (adjusted OR 2.16, 95% CI 1.34-3.50, P < 0.002). However, there was no significant improvement found in the secondary outcomes.
  
  
  
  This study demonstrates that the EMPOWER-PAR intervention was effective in improving the primary outcome for type 2 diabetes in the Malaysian public primary care setting.
  
  
  
  Registered with: ClinicalTrials.gov.: NCT01545401 . Date of registration: 1st March 2012.
authors.affiliation: Discipline of Primary Care Medicine, Faculty of Medicine, Universiti Teknologi MARA (UiTM), Selayang Campus, Jalan Prima Selayang 7, 68100, Batu Caves, Selangor, Malaysia. rossanis_yuzadi@yahoo.co.uk.|Institute for Pathology, Laboratory and Forensic Medicine (I-PPerForM), Universiti Teknologi MARA (UiTM), Sungai Buloh Campus, Jalan Hospital, 47000, Sungai Buloh, Selangor, Malaysia. rossanis_yuzadi@yahoo.co.uk.
authors.forename: Anis Safura
authors.initials: AS
authors.lastname: Ramli
authors.affiliation: Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, Netherlands.
authors.forename: Sharmini
authors.initials: S
authors.lastname: Selvarajah
authors.affiliation: Discipline of Primary Care Medicine, Faculty of Medicine, Universiti Teknologi MARA (UiTM), Selayang Campus, Jalan Prima Selayang 7, 68100, Batu Caves, Selangor, Malaysia.|Institute for Pathology, Laboratory and Forensic Medicine (I-PPerForM), Universiti Teknologi MARA (UiTM), Sungai Buloh Campus, Jalan Hospital, 47000, Sungai Buloh, Selangor, Malaysia.
authors.forename: Maryam Hannah
authors.initials: MH
authors.lastname: Daud
authors.affiliation: Clinical Epidemiology Unit, National Clinical Research Centre, Ministry of Health Malaysia, Kuala Lumpur, Malaysia.
authors.forename: Jamaiyah
authors.initials: J
authors.lastname: Haniff
authors.affiliation: Discipline of Primary Care Medicine, Faculty of Medicine, Universiti Teknologi MARA (UiTM), Selayang Campus, Jalan Prima Selayang 7, 68100, Batu Caves, Selangor, Malaysia.|Institute for Pathology, Laboratory and Forensic Medicine (I-PPerForM), Universiti Teknologi MARA (UiTM), Sungai Buloh Campus, Jalan Hospital, 47000, Sungai Buloh, Selangor, Malaysia.
authors.forename: Suraya
authors.initials: S
authors.lastname: Abdul-Razak
authors.affiliation: Clinical Epidemiology Unit, National Clinical Research Centre, Ministry of Health Malaysia, Kuala Lumpur, Malaysia.
authors.forename: Tg Mohd Ikhwan
authors.initials: TM
authors.lastname: Tg-Abu-Bakar-Sidik
authors.affiliation: Clinical Epidemiology Unit, National Clinical Research Centre, Ministry of Health Malaysia, Kuala Lumpur, Malaysia.
authors.forename: Mohamad Adam
authors.initials: MA
authors.lastname: Bujang
authors.affiliation: Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor, Malaysia.
authors.forename: Boon How
authors.initials: BH
authors.lastname: Chew
authors.affiliation: Institute for Pathology, Laboratory and Forensic Medicine (I-PPerForM), Universiti Teknologi MARA (UiTM), Sungai Buloh Campus, Jalan Hospital, 47000, Sungai Buloh, Selangor, Malaysia.
authors.forename: Thuhairah
authors.initials: T
authors.lastname: Rahman
authors.affiliation: Department of Family Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.
authors.forename: Seng Fah
authors.initials: SF
authors.lastname: Tong
authors.affiliation: School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia.
authors.forename: Asrul Akmal
authors.initials: AA
authors.lastname: Shafie
authors.affiliation: Department of Family Medicine, School of Medicine, International Medical University, Bukit Jalil, Kuala Lumpur, Malaysia.
authors.forename: Verna K M
authors.initials: VK
authors.lastname: Lee
authors.affiliation: Faculty of Medicine & Defense Health, National Defense University of Malaysia, Sungai Besi Camp, Kuala Lumpur, Malaysia.
authors.forename: Kien Keat
authors.initials: KK
authors.lastname: Ng
authors.affiliation: Discipline of Primary Care Medicine, Faculty of Medicine, Universiti Teknologi MARA (UiTM), Selayang Campus, Jalan Prima Selayang 7, 68100, Batu Caves, Selangor, Malaysia.
authors.forename: Farnaza
authors.initials: F
authors.lastname: Ariffin
authors.affiliation: Discipline of Primary Care Medicine, Faculty of Medicine, Universiti Teknologi MARA (UiTM), Selayang Campus, Jalan Prima Selayang 7, 68100, Batu Caves, Selangor, Malaysia.
authors.forename: Hasidah
authors.initials: H
authors.lastname: Abdul-Hamid
authors.affiliation: Discipline of Primary Care Medicine, Faculty of Medicine, Universiti Teknologi MARA (UiTM), Selayang Campus, Jalan Prima Selayang 7, 68100, Batu Caves, Selangor, Malaysia.
authors.forename: Md Yasin
authors.initials: MY
authors.lastname: Mazapuspavina
authors.affiliation: Discipline of Primary Care Medicine, Faculty of Medicine, Universiti Teknologi MARA (UiTM), Selayang Campus, Jalan Prima Selayang 7, 68100, Batu Caves, Selangor, Malaysia.
authors.forename: Nafiza
authors.initials: N
authors.lastname: Mat-Nasir
authors.affiliation: Department of Family Medicine, School of Medicine, International Medical University, Bukit Jalil, Kuala Lumpur, Malaysia.
authors.forename: Chun W
authors.initials: CW
authors.lastname: Chan
authors.affiliation: Discipline of Family Medicine, Faculty of Medicine, Cyberjaya University College of Medical Sciences, Cyberjaya, Selangor, Malaysia.
authors.forename: Abdul Rahman
authors.initials: AR
authors.lastname: Yong-Rafidah
authors.affiliation: Klinik Kesihatan Seremban 2, Seremban, Negeri Sembilan, Malaysia.
authors.forename: Mastura
authors.initials: M
authors.lastname: Ismail
authors.affiliation: Clinical Epidemiology Unit, National Clinical Research Centre, Ministry of Health Malaysia, Kuala Lumpur, Malaysia.
authors.forename: Sharmila
authors.initials: S
authors.lastname: Lakshmanan
authors.affiliation: Monash Health, Monash Medical Centre, Clayton Campus, Clayton, VIC, Australia.
authors.forename: Wilson H H
authors.initials: WH
authors.lastname: Low
mesh_terms: D001794:Blood Pressure; D015992:Body Mass Index; D002908:Chronic Disease; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000628:therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism*; D006801:Humans; D008055:Lipids / Q000097:blood; D008296:Malaysia; D008297:Male; D008875:Middle Aged; D008962:Models, Theoretical; D011320:Primary Health Care / Q000379:methods*; D055105:Waist Circumference
chemical_list: D006442:Glycated Hemoglobin; D008055:Lipids; C517652:hemoglobin A1c protein, human
keywords: Chronic care model; Chronic disease management; Clinical outcomes; Family medicine; Multifaceted intervention; Primary care; Type 2 diabetes mellitus