Integration of Health Coaching and Diabetes Education in Type 2 Diabetes Mellitus Management at Primary Health Care

Sponsor
Indonesia University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05090488
Collaborator
Provincial Health Services Authority (Other)
180
Enrollment
1
Location
2
Arms
12.6
Anticipated Duration (Months)
14.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Type 2 Diabetes Mellitus is a chronic disease with increasing incidence globally. It needs a comprehensive and continuous management approach that includes five pillars: education, nutritional management, physical activity, pharmacological treatment, and monitoring. To achieve good glycemic control, prevention of complications, and good quality of life as diabetes management goals, patients' capability to properly navigate diabetes management is a key. One evidence-based model to empower patients' self-management abilities is diabetes education and health coaching. Diabetes management at primary health care needs special concern since they play an important role in initial and continuing care for diabetes patients in the community. Therefore, the implementation of diabetes education and health coaching in primary health care is expected to improve the self-management abilities of people with diabetes

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Personal Health Coaching and Diabetes Education in Group
N/A

Detailed Description

A randomized control trial, pre and post study involving 180 subjects randomized into 2 arms:
  • Control : received education in group

  • Intervention : received education group + personal health coaching Education group divided into 6 session, which for each session consist of 2 different topics and lasts for 60 minutes.

Health coaching was given by a coach, a healthcare professional who undergo training to become a coach. Health coaching delivered as face to face between subjects and coach.

Laboratory examination, anthropometric measurement, echocardiography, electrocardiography, Heart Rate Variability measurement, diabetic eye screening, and questionnaire collected at baseline, 3 and 6 months after intervention

Study Design

Study Type:
Interventional
Actual Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Integration of Health Coaching and Diabetes Education in Type 2 Diabetes Mellitus Patients at Jakarta Primary Health Care: Role on Metabolic Control, Diabetes Complications, Inflammatory Marker, Behavior Changes, and Quality of Life
Actual Study Start Date :
Dec 14, 2020
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Jan 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Received Personal Health Coaching and Diabetes Education in Group

Health coaching was given as face to face with a trained coach from primary health care. Diabetes education in group, with trained educator team from primary health care

Behavioral: Personal Health Coaching and Diabetes Education in Group
Health coaching was given as face to face with a trained coach from primary health care. Diabetes education in group, with trained educator team from primary health care

Active Comparator: Received Diabetes Education in Group

Diabetes education in group, with trained educator team from primary health care

Behavioral: Personal Health Coaching and Diabetes Education in Group
Health coaching was given as face to face with a trained coach from primary health care. Diabetes education in group, with trained educator team from primary health care

Outcome Measures

Primary Outcome Measures

  1. Change from baseline HbA1C at 3 months and 6 months [Baseline, 3 and 6 months after intervention]

    HbA1C is indicator of glycemic control

Secondary Outcome Measures

  1. Change from baseline fasting plasma glucose at 3 and 6 months [Baseline, 3 and 6 months after intervention]

    Blood glucose monitoring

  2. Change from baseline serum lipid at 3 and 6 months [Baseline, 3 and 6 months after intervention]

    Lipid profile measurement includes total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides

  3. Change from baseline inflammatory marker at 3 and 6 months [Baseline, 3 and 6 months after intervention]

    Inflammatory marker used is hs-CRP (C-reactive protein)

  4. Change from baseline body mass index [Baseline, 3 and 6 months after intervention]

    Body mass index described by kg/m2

  5. Change from baseline waist circumference [Baseline, 3 and 6 months after intervention]

    Waist circumference measured by cm

  6. Change from baseline body fat [Baseline, 3 and 6 months after intervention]

    Body fat measured by body impedance analysis

  7. Change from baseline left ventricular mass index [Baseline, 6 months after intervention]

    Left ventricular mass index measured using standard formula and corrected by body surface area

  8. Change from baseline left ventricular systolic function [Baseline, 6 months after intervention]

    Left ventricular systolic funciton was calculated from ejection fraction and global longitudinal strain (measured by echocardiography)

  9. Change from baseline left atrial volume [Baseline, 6 months after intervention]

    Left atrial volume was measured through biplane area calculation in echocardiography procedure

  10. Change from baseline right ventricular systolic function [Baseline, 6 months after intervention]

    Right ventricular systolic function was evaluated using TAPSE

  11. change from baseline left ventricular diastolic function [Baseline, 6 months after intervention]

    LV diastolic function was evaluated according to algorithm recommended by American Society of Echochardiography in 2016

  12. Change from baseline electrocardiography pattern [Baseline and 6 months after intervention]

    Electrocardiography pattern was used to analyze cardiac rythm

  13. Change from baseline heart rate variability [Baseline and 6 months after intervention]

    Heart rate variability was measured using ECG Holter examination

  14. Baseline visual acuity [Baseline]

    Visual acuity was measured by Peek acuity chart application using WHO classification

  15. Baseline lens haziness [Baseline]

    Lens haziness was evaluated using shadow test

  16. Baseline retina examination [Baseline]

    Retina was examined using funduscopic photography

  17. Baseline intraocular pressure [Baseline]

    Intraocular pressure was measured by cup-to-disc ratio using funduscopic photograpy

  18. Change from baseline peripheral sensory neuropathy [Baseline, 3 and 6 months after intervention]

    Peripheral sensory neuropathy was measured using combination of subjective manifestation, 10 g Simme Weinstein monofilament and 128 Hz tuning fork

  19. Change from baseline peripheral autonomic neuropathy [Baseline, 3 and 6 months after intervention]

    Peripheral autonomic neuropathy was seen visually by objective examination (dry, scaly skin and cracked skin)

  20. Change from baseline peripheral motor neuropathy [Baseline, 3 and 6 months after intervention]

    Peripheral motor neuropathy was seen visually by objective examination (changes in the shape of fingers, muscle atrophy, or bone protrusions)

  21. Change from baseline peripheral arterial disease [Baseline, 3 and 6 months after intervention]

    Peripheral arterial disease was diagnosed through ankle brachial index measurement

  22. Change from baseline renal function [Baseline and 6 months after intervention]

    Renal function was measured by estimated glomerular filtration rate (eGFR) using creatinine data

  23. Change from baseline albuminuria [Baseline and 6 months after intervention]

    Albuminuria was measured by albumin creatinine ratio

  24. Change from baseline mean calorie intake [Baseline, 3 and 6 months after intervention]

    Evaluation of mean calorie intake using food record data

  25. Change from baseline global physical activity [Baseline, 3 and 6 months after intervention]

    Global physical activity was evaluated by global physical activity questionnaire

  26. Change from baseline medication adherence [Baseline, 3 and 6 months]

    Medication adherence was measured by Morisky Medication Adherence Scale (MMAS)

  27. Change from baseline quality of life [Baseline, 3 and 6 months]

    Quality of life was evaluated by EuroQol five-dimensional questionnaire. This questionnaire evaluates 5 dimensions of life. Each dimension scores 1-5 (1 means no problem and 5 means extreme problems).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Type 2 Diabetes Mellitus

  • = 18 years old

  • Willing to follow the research by signing an informed consent

Exclusion Criteria:
  • Patients with cognitive disease (such as dementia)

  • Patients with hearing or sight problem

  • Unable to live independently on daily basis

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of IndonesiaJakartaDKI JakartaIndonesia

Sponsors and Collaborators

  • Indonesia University
  • Provincial Health Services Authority

Investigators

  • Principal Investigator: Em Yunir, PhD, Divisi Metabolik Endokrin IPD FKUI RSCM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Em Yunir, DR. dr. Em Yunir, SpPD, KEMD, Indonesia University
ClinicalTrials.gov Identifier:
NCT05090488
Other Study ID Numbers:
  • Health Coaching Jakarta
First Posted:
Oct 22, 2021
Last Update Posted:
Nov 11, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Em Yunir, DR. dr. Em Yunir, SpPD, KEMD, Indonesia University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 11, 2021