The Effectiveness of "CARE Coaching Model" as an Effort to Empower Type 2 Diabetes Mellitus Patients

NCT ID: NCT04289818

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2020-03-31

Brief Summary

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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.

Detailed Description

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Subjects randomized into 2 groups: control and intervention group. All subject received education class in top of standard treatment. Intervention group received additional personal health coaching.

Education and health coaching was given for 12 sessions every 2 weeks with 12 different themes for each session. Health coaching were given by International certified health coach.

Laboratory examination and questionnaire collected at baseline, 3 and 6 months after intervention.

Conditions

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Diabetes Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

Conventional Education Class

Group Type NO_INTERVENTION

No interventions assigned to this group

Coaching

Health Coaching

Group Type EXPERIMENTAL

Health Coaching

Intervention Type OTHER

Health Coaching as face to face with a coach

Interventions

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Health Coaching

Health Coaching as face to face with a coach

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* T2DM patients
* aged 30-60 years old
* HbA1C \> 7.5% within the past 3 months
* able to write and read.

Exclusion Criteria

* 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)
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. dr. Pradana Soewondo, SpPD-KEMD

Professor, Endocrinologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pradana Soewondo, Prof

Role: PRINCIPAL_INVESTIGATOR

Fakultas Kedokteran Universitas Indonesia

Locations

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Faculty of Medicine, Universitas Indonesia

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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PS002

Identifier Type: -

Identifier Source: org_study_id

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