- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07571590
Effectiveness of a Self-Efficacy Based Educational Program on Glycemic Self-Monitoring, Diabetes Self-Management Knowledge, and Health-Related Quality of Life Among Adults With Type 2 Diabetes Mellitus (T2DM-SM-QOL-)
Effectiveness of a Self-Efficacy-Based Educational Program on Glycemic Self-Monitoring, Diabetes Self-Management Knowledge, and Health-Related Quality of Life Among Adults With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effectiveness of a self-efficacy-based educational program on glycemic self-monitoring, diabetes self-management knowledge, and health-related quality of life among adults with Type 2 Diabetes Mellitus. Participants will be randomly assigned to either an intervention group receiving the educational program or a control group receiving standard care.
The educational program is designed to enhance patients' confidence (self-efficacy) in managing their condition, including blood glucose monitoring, adherence to treatment, lifestyle modification, and self-care practices. Outcomes will be assessed using validated tools to measure improvements in self-monitoring behaviors, knowledge, and quality of life.
The findings of this study are expected to provide evidence on the effectiveness of educational interventions in improving diabetes management and patient outcomes.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
Type 2 Diabetes Mellitus is a chronic metabolic disorder that requires continuous self-management, including blood glucose monitoring, medication adherence, diet control, and lifestyle modification. Poor self-management is associated with increased risk of complications and reduced quality of life.
Self-efficacy, defined as an individual's belief in their ability to perform specific behaviors, plays a critical role in diabetes self-management. Educational interventions based on self-efficacy theory have shown potential in improving patients' confidence and ability to manage their condition effectively.
This study is a randomized controlled trial designed to evaluate the effectiveness of a self-efficacy-based educational program among adults with Type 2 Diabetes Mellitus. A total of 400 participants will be recruited and randomly assigned to either the intervention group or the control group.
Participants in the intervention group will receive a structured educational program focusing on enhancing self-efficacy related to glycemic self-monitoring, diabetes knowledge, and self-care behaviors. The program will include interactive sessions, practical demonstrations, and educational materials. The control group will receive standard care provided by healthcare services.
Data will be collected at baseline and after the intervention using validated instruments to assess glycemic self-monitoring practices, diabetes self-management knowledge, and health-related quality of life.
The primary outcomes of this study include improvement in glycemic self-monitoring behaviors and diabetes-related knowledge. Secondary outcomes include improvement in health-related quality of life.
The results of this study are expected to contribute to the growing body of evidence supporting the role of self-efficacy-based interventions in chronic disease management and may inform future clinical practice and educational strategies.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Jawad ABU-SHENNAR, Asst.Prof.Dr
- Puhelinnumero: +962779084560
- Sähköposti: JAWAD_0799@YAHOO.COM
Opiskelupaikat
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-
Dours
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Jerash, Dours, Jordania, 009627
- Ministry of Health Primary Healthcare Centers
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Ottaa yhteyttä:
- Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr
- Puhelinnumero: 0779084560
- Sähköposti: JAWAD_0799@YAHOO.COM
-
Ottaa yhteyttä:
- Sähköposti: JAWAD_0799@YAHOO.COM
-
Päätutkija:
- Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr
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-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
- Adults aged 18 years and above
- Diagnosed with Type 2 Diabetes Mellitus (T2DM)
- Attending Jordanian Ministry of Health healthcare facilities for at least six months with regular follow-up visits
- Able to perform or learn self-monitoring of blood glucose (SMBG)
- Able to use a glucometer independently
- Willing to participate and provide informed consent
Exclusion Criteria:
- Patients with Type 1 diabetes mellitus or gestational diabetes
- Patients with physical or cognitive impairments that limit the ability to perform SMBG independently
- Pregnant or lactating women
- Patients with severe medical conditions such as renal failure or cardiovascular instability that may affect participation
- Patients with other conditions that may hinder study participation
- Patients who do not provide informed consent
- Patients who fail to respond to study instruments
- Patients who participated in similar educational programs within the past six months
- Patients currently using corticosteroid medications due to their effect on blood glucose levels
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Muut
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: Self-Efficacy Educational Program Groups
Participants in this arm will receive a structured self-efficacy-based educational program designed to improve glycemic self-monitoring, diabetes self-management knowledge, and health-related quality of life among adults with Type 2 Diabetes Mellitus. The intervention is based on self-efficacy theory and focuses on enhancing patients' confidence in performing diabetes self-care behaviors. The program is delivered through structured educational sessions conducted by trained healthcare professionals. It includes interactive lectures, group discussions, demonstrations, and practical training covering blood glucose self-monitoring, medication adherence, dietary management, physical activity, and prevention of diabetes-related complications. Educational materials such as printed handouts and visual aids are provided to reinforce learning. The intervention is delivered over a defined number of sessions within a specific timeframe. |
A structured self-efficacy-based educational program designed for adults with Type 2 Diabetes Mellitus to improve glycemic self-monitoring, diabetes self-management knowledge, and health-related quality of life. The program is grounded in self-efficacy theory and aims to enhance patients' confidence in performing diabetes self-care behaviors. The intervention is delivered through scheduled educational sessions conducted by trained healthcare professionals and includes interactive lectures, group discussions, demonstrations, and practical training. Key topics include blood glucose self-monitoring, medication adherence, dietary management, physical activity, complication prevention, and problem-solving strategies for diabetes self-care. Educational materials such as printed booklets and visual aids are used to reinforce learning. The program is implemented over a defined number of sessions within a specified period, while the control group receives standard routine care only. |
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Active Comparator: Control Group
Participants in this arm will receive standard routine care for Type 2 Diabetes Mellitus as provided in usual clinical practice at the healthcare facilities. This includes regular follow-up visits, general medical advice, and standard education related to diabetes management as offered by healthcare providers. No structured or additional self-efficacy-based educational program will be provided to this group. Participants will continue their usual care without any additional intervention from the research team. |
A structured self-efficacy-based educational program designed for adults with Type 2 Diabetes Mellitus to improve glycemic self-monitoring, diabetes self-management knowledge, and health-related quality of life. The program is grounded in self-efficacy theory and aims to enhance patients' confidence in performing diabetes self-care behaviors. The intervention is delivered through scheduled educational sessions conducted by trained healthcare professionals and includes interactive lectures, group discussions, demonstrations, and practical training. Key topics include blood glucose self-monitoring, medication adherence, dietary management, physical activity, complication prevention, and problem-solving strategies for diabetes self-care. Educational materials such as printed booklets and visual aids are used to reinforce learning. The program is implemented over a defined number of sessions within a specified period, while the control group receives standard routine care only. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Diabetes Self-Management Behaviors Measured Using the Diabetes Self-Management Questionnaire (DSMQ)
Aikaikkuna: Baseline and 3 months after intervention
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Change in diabetes self-management behaviors measured using the Diabetes Self-Management Questionnaire (DSMQ).
The DSMQ is a 16-item validated self-report instrument developed by Schmitt et al. (2013) to assess diabetes self-care behaviors that influence glycemic control, including glucose management, dietary control, physical activity, and healthcare utilization.
Items are rated on a Likert scale, with higher scores indicating better self-management.
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Baseline and 3 months after intervention
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Diabetes Knowledge Measured Using the Diabetes Knowledge Questionnaire (DKQ)
Aikaikkuna: Baseline and 3 months post-intervention
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Change in diabetes knowledge measured using the Diabetes Knowledge Questionnaire (DKQ).
The DKQ is a validated 24-item instrument developed to assess patients' understanding of diabetes management, including causes, symptoms, complications, diet, exercise, medication adherence, and blood glucose control.
Items are answered in a Yes/No/Don't know format, with one point awarded for each correct answer.
Total scores range from 0 to 24, with higher scores indicating greater diabetes knowledge.
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Baseline and 3 months post-intervention
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Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Health-Related Quality of Life Measured Using the EQ-5D-5L Questionnaire
Aikaikkuna: Baseline and 3 months post-intervention
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Change in health-related quality of life measured using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire.
The EQ-5D-5L includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on a 5-level scale ranging from no problems to extreme problems.
The EQ-5D index score typically ranges from values below 0 (worse than death) to 1 (full health), where higher scores indicate better health-related quality of life.
Additionally, overall health status is assessed using the EQ Visual Analog Scale (EQ-VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health).
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Baseline and 3 months post-intervention
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr, Jerash University, Faculty of Nursing
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- T2DM-SM-QOL-RCT-2026
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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