Diabetes Type 2NCT07613086
The Role of Self-efficacy Program for Self-management of People With Type Diabetes Mellitus
A study testing Self-Efficacy Program for Diabetes Self-Management in people with Diabetes Type 2, run by Gadjah Mada University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- Self-Efficacy Program for Diabetes Self-Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteIndonesia
- Study dates
- 14 Sep 2019to 15 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Puskesmas (Primary Health Care) Gedongtengen
Yogyakarta, DI Yogyakarta, 55272
About this study
Official title: The Role of Self-Efficacy Program for Self-Management of People With Type 2 Diabetes Mellitus: A Mixed Methods Exploratory Study
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.
Read more
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
- Being tested
- Self-Efficacy Program for Diabetes Self-Management
- Keywords
- self-efficacy program, mixed method, self-management, type 2 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Efficacy Program for Diabetes Self-ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Post-intervention (after completion of the 4-week program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start14 Sep 2019
- Primary completion22 Oct 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nida Ul Hasanat, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613086
- Sponsor's protocol ID
- 6536/UN1/FPSi.1.3/SD/PT/2019
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Self-Efficacy Program for Self-Management of People With Type 2 Diabetes Mellitus: A Mixed Methods Exploratory Study
- ClinicalTrials.gov ID
- NCT07613086
- Acronym / sponsor ID
- 6536/UN1/FPSi.1.3/SD/PT/2019
- Conditions
- Diabetes Type 2
- Keywords
- self-efficacy program, mixed method, self-management, type 2 diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 14 Sep 2019 (actual)
- Primary completion
- 22 Oct 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Efficacy Program Group | Experimental | Behavioral: Self-Efficacy Program for Diabetes Self-ManagementParticipants 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. |
| 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Efficacy Program for Diabetes Self-ManagementA 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. | Behavioural | Self-Efficacy Program Group |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Efficacy Program for Diabetes Self-Management in people with Diabetes Type 2, run by Gadjah Mada University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Self-Management (time frame: Baseline (pre-intervention) and immediately post-intervention (after 4 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.