Integration of Health Coaching and Diabetes Education in Type 2 Diabetes Mellitus Management at Primary Health Care
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
1 other identifier
interventional
200
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 14, 2020
CompletedFirst Submitted
Initial submission to the registry
February 11, 2021
CompletedFirst Posted
Study publicly available on registry
October 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedApril 20, 2022
April 1, 2022
2.5 years
February 11, 2021
April 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline HbA1C at 3 months and 6 months
HbA1C is indicator of glycemic control
Baseline, 3 and 6 months after intervention
Secondary Outcomes (27)
Change from baseline fasting plasma glucose at 3 and 6 months
Baseline, 3 and 6 months after intervention
Change from baseline serum lipid at 3 and 6 months
Baseline, 3 and 6 months after intervention
Change from baseline inflammatory marker at 3 and 6 months
Baseline, 3 and 6 months after intervention
Change from baseline body mass index
Baseline, 3 and 6 months after intervention
Change from baseline waist circumference
Baseline, 3 and 6 months after intervention
- +22 more secondary outcomes
Study Arms (2)
Received Personal Health Coaching and Diabetes Education in Group
EXPERIMENTALHealth 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
Received Diabetes Education in Group
ACTIVE COMPARATORDiabetes education in group, with trained educator team from primary health care
Interventions
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
Eligibility Criteria
You may qualify if:
- Type 2 Diabetes Mellitus
- \>= 18 years old
- Willing to follow the research by signing an informed consent
You may not qualify if:
- Patients with cognitive disease (such as dementia)
- Patients with hearing or sight problem
- Unable to live independently on daily basis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Indonesia
Jakarta, DKI Jakarta, Indonesia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Em Yunir, PhD
Divisi Metabolik Endokrin IPD FKUI RSCM
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DR. dr. Em Yunir, SpPD, KEMD
Study Record Dates
First Submitted
February 11, 2021
First Posted
October 22, 2021
Study Start
December 14, 2020
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
April 20, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share