The Effectiveness of "CARE Coaching Model" as an Effort to Empower Type 2 Diabetes Mellitus Patients
Efektivitas "CARE Coaching Model" Sebagai Upaya Pemberdayaan Pasien Diabetes Untuk Meningkatkan Status Kesehatan Dan Perilaku Pengendalian Diabetes
1 other identifier
interventional
60
1 country
1
Brief Summary
In Indonesia and others countries, only 30.8% patients with type 2 diabetes mellitus (T2DM) achieved glycemic control with HbA1c \<7%. Optimal pharmacological treatment alone does not guarantee an optimal outcome, therefore it should be combined with lifestyle management. Health coaching helps T2DM patients increase self awareness to improve and maintain behavior which play a role in self-management. This study aims to evaluate the impact of health coaching on glycemic control on T2DM patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2018
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
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2018
CompletedFirst Submitted
Initial submission to the registry
February 10, 2020
CompletedFirst Posted
Study publicly available on registry
February 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedNovember 2, 2022
November 1, 2022
7 months
February 10, 2020
November 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from Baseline HbA1c at 3 months
Glycemic Control
3 month after intervention
Change from Baseline HbA1c at 6 months
Glycemic Control
6 month after intervention
Secondary Outcomes (19)
Change from Baseline Fasting Plasma Glucose at 3 months
3 month after intervention
Change from Baseline 2-hours post prandial plasma glucose at 3 months
3 months after intervention
Change from HDL-cholesterol at 3 months
3 months after intervention
Change from LDL-cholesterol at 3 months
3 months after intervention
Change from Triglycerides at 3 months
3 months after intervention
- +14 more secondary outcomes
Study Arms (2)
Control
NO INTERVENTIONConventional Education Class
Coaching
EXPERIMENTALHealth Coaching
Interventions
Eligibility Criteria
You may qualify if:
- T2DM patients
- aged 30-60 years old
- HbA1C \> 7.5% within the past 3 months
- able to write and read.
You may not qualify if:
- Patients with cognitive disease (such as dementia)
- having hearing problem or sight problem
- unable to live independently on daily basis
- having disease that may affect HbA1c result (eg: hemolytic anemia)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, DKI Jakarta, 10430, Indonesia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pradana Soewondo, Prof
Fakultas Kedokteran Universitas Indonesia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Endocrinologist
Study Record Dates
First Submitted
February 10, 2020
First Posted
February 28, 2020
Study Start
February 1, 2018
Primary Completion
August 31, 2018
Study Completion
March 31, 2020
Last Updated
November 2, 2022
Record last verified: 2022-11