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Completed

NCT Number: NCT07613086

The Role of Self-efficacy Program for Self-management of People With Type Diabetes Mellitus

The goal of this clinical trial is to learn if a self-efficacy program can improve diabetes self-management behaviors in adults with Type 2 Diabetes Mellitus attending primary health centers (Puskesmas) in Yogyakarta, Indonesia. The main questions it aims to answer are:

* Does a self-efficacy program improve diabetes self-management behaviors (measured by the Summary of Diabetes Self-Care Activities/SDSCA)? * Does a self-efficacy program enhance diabetes self-efficacy (measured by the Diabetes Self-Efficacy Scale)? Researchers will compare participants receiving the self-efficacy program (intervention group) to a waiting-list control group to see if the program leads to greater improvements in self-management and self-efficacy.

Participants will:

* Attend four weekly group sessions (60-90 minutes each) covering diabetes knowledge, goal setting, self-monitoring, and peer support * Complete questionnaires on diabetes self-management and self-efficacy at baseline and after the intervention period * Selected participants in the intervention group will take part in semi-structured interviews about their experience with the program

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Key information

Conditions

Diabetes Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Puskesmas (Primary Health Care) Gedongtengen

Yogyakarta, DI Yogyakarta, 55272, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • individuals diagnosed with Type 2 Diabetes Mellitus for a minimum of one year;
  • exhibiting low or moderate scores on the Diabetes Self-management Scale;
  • no prior experience with similar programs or concurrent participation in other related activities

Treatment and study plan

Self-Efficacy Program for Diabetes Self-Management

Behavioral

A structured group-based behavioral intervention grounded in Bandura's Self-Efficacy Theory. The program consisted of four weekly sessions (60-90 minutes each) facilitated by a trained nurse researcher. Session 1 focused on diabetes knowledge enhancement and personal goal setting. Session 2 covered self-monitoring techniques and identifying barriers to self-care. Session 3 involved peer experience sharing and problem-solving strategies. Session 4 included review of progress, reinforcement of skills, and relapse prevention planning. The intervention targeted four sources of self-efficacy: mastery experience, vicarious experience, verbal persuasion, and physiological/emotional states.

Primary outcomes

  1. Diabetes Self-Management

    Time frame: Baseline (pre-intervention) and immediately post-intervention (after 4 weeks)

    Measured using the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire, which assesses self-care behaviors across five domains: general diet, specific diet, exercise, blood glucose testing, and foot care. Scores represent the number of days per week (0-7) participants performed each self-care activity.

  2. Diabetes Self-Efficacy

    Time frame: Baseline (pre-intervention) and immediately post-intervention (after 4 weeks)

    Measured using the Diabetes Self-Efficacy Scale (DSES), which assesses participants' confidence in performing diabetes self-management tasks. The scale uses a Likert-type response format with higher scores indicating greater self-efficacy.

  3. Participants' Experiences with the Self-Efficacy Program

    Time frame: Post-intervention (after completion of the 4-week program)

    Qualitative data collected through semi-structured interviews with a purposive subsample of intervention group participants. Interviews explored participants' perceptions, experiences, and perceived impact of the self-efficacy program on their diabetes self-management. Data were analyzed using thematic analysis.

Sponsors and collaborators

Lead sponsor

Gadjah Mada University

Other

Registry information

Official study title

The Role of Self-Efficacy Program for Self-Management of People With Type 2 Diabetes Mellitus: A Mixed Methods Exploratory Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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