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

NCT07613086 | Completed

• 1 other identifier: 6536/UN1/FPSi.1.3/SD/PT/2019
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Type 2

Keywords

self-efficacy program; mixed method; self-management; type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (3)

• Diabetes Self-Management

  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.

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

• Diabetes Self-Efficacy

  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.

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

• Participants' Experiences with the Self-Efficacy 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.

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

Study Arms (2)

Self-Efficacy Program Group

EXPERIMENTAL

Participants at the intervention Puskesmas received a structured self-efficacy program consisting of four weekly group sessions (60-90 minutes each) delivered by a trained nurse researcher. Sessions covered diabetes knowledge enhancement, personal goal setting, self-monitoring techniques, peer experience sharing, problem-solving strategies, progress review, and relapse prevention planning. The program was grounded in Bandura's Self-Efficacy Theory, targeting mastery experience, vicarious experience, verbal persuasion, and physiological/emotional states.

Behavioral: Self-Efficacy Program for Diabetes Self-Management

Waiting-List Control Group

NO INTERVENTION

Participants at the control Puskesmas received usual care as routinely provided by the primary health center (Puskesmas). No additional intervention was given during the study period. Participants in this group were offered the self-efficacy program after data collection was completed.

Interventions

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.

Self-Efficacy Program Group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Gadjah Mada University: lead

Study Sites (1)

Puskesmas (Primary Health Care) Gedongtengen

Yogyakarta, DI Yogyakarta, 55272, Indonesia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 29, 2026
• Study Start: September 14, 2019
• Primary Completion: October 22, 2019
• Study Completion: December 15, 2019
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

ID (1)