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- Essai clinique NCT07613086
The Role of Self-efficacy Program for Self-management of People With Type Diabetes Mellitus
23 mai 2026 mis à jour par: Nida Ul Hasanat, Gadjah Mada University
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.
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
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
16
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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DI Yogyakarta
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Yogyakarta, DI Yogyakarta, Indonésie, 55272
- Puskesmas (Primary Health Care) Gedongtengen
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Self-Efficacy Program Group
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.
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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.
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Aucune intervention: Waiting-List Control Group
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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Diabetes Self-Management
Délai: Baseline (pre-intervention) and immediately post-intervention (after 4 weeks)
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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.
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Baseline (pre-intervention) and immediately post-intervention (after 4 weeks)
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Diabetes Self-Efficacy
Délai: Baseline (pre-intervention) and immediately post-intervention (after 4 weeks)
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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.
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Baseline (pre-intervention) and immediately post-intervention (after 4 weeks)
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Participants' Experiences with the Self-Efficacy Program
Délai: Post-intervention (after completion of the 4-week program)
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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.
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Post-intervention (after completion of the 4-week program)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
14 septembre 2019
Achèvement primaire (Réel)
22 octobre 2019
Achèvement de l'étude (Réel)
15 décembre 2019
Dates d'inscription aux études
Première soumission
18 mai 2026
Première soumission répondant aux critères de contrôle qualité
23 mai 2026
Première publication (Réel)
29 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
29 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 6536/UN1/FPSi.1.3/SD/PT/2019
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .