Type 2 Diabetes Clinical Trial
Official title:
A Patient-Centered Self-Management Intervention to Improve Glycemic Control, Self-Efficacy and Self-Care Behaviors in Adults With Type 2 Diabetes Mellitus: Randomized Controlled Trial
NCT number | NCT05491252 |
Other study ID # | 335-21 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 21, 2022 |
Est. completion date | February 17, 2023 |
Verified date | April 2023 |
Source | Shifa Tameer-e-Millat University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Type 2 Diabetes Mellitus (DM) is a serious health problem for Pakistan and around the world due to its increasing prevalence and the risk of adverse health outcomes including kidney failure, heart attack, stroke, leg amputation and blindness. These problems reduce the quality of life of individuals with type 2 DM and increase their financial burden, thereby affecting the national economy. Given its huge health and economic impact, preventing type 2 DM progression and reducing the risk of associated complications requires immediate attention. Evidence suggests that self-management can slow the progression of type 2 DM, minimizes the risk of major complications and hence, lowers health-care costs. The purpose of this study is to test the effectiveness of a patient centered self-management intervention to improve health outcomes in adults with type 2 DM. It is expected that patients receiving this intervention would have improved health outcomes as compared to patients who did not.
Status | Completed |
Enrollment | 612 |
Est. completion date | February 17, 2023 |
Est. primary completion date | February 7, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Adult (aged 18 years or above) 2. Diagnosed with type 2 Diabetes Mellitus for at least 06 months duration. 3. Willing to participate in the study by signing of the consent form. Exclusion Criteria: 1. Type 2 DM Patient with HbA1c < 7 2. Uncontrolled psychological comorbidity (psychosis, schizophrenia, dementia or severe learning difficulties). 3. Severe comorbidity that may limit participation (medical conditions such as cancer, stroke with disabilities, or need for regular dialysis etc. that preclude complete participation in this study). 4. Life expectancy of less than six months as determined by patient's primary physician. 5. Living outside of Faisalabad City. |
Country | Name | City | State |
---|---|---|---|
Pakistan | Allied Hospital | Faisalabad | Punjab |
Pakistan | District Head Quarter (DHQ) Hospital | Faisalabad | Punjab |
Pakistan | Government General Hospital | Faisalabad | Punjab |
Pakistan | Punjab Social Security Hospital | Faisalabad | Punjab |
Lead Sponsor | Collaborator |
---|---|
Shifa Tameer-e-Millat University |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Glycemic Control (HbA1c) | HbA1c will be measured by collecting venous plasma samples and sending them to the single central laboratory to assure consistency and uniformity in methodology. The samples will be drawn by Data Collectors/Outcome Assessors and laboratory measurements will be performed by a trained laboratory technician. | HbA1c will be measured at three points in time (1) at baseline, (2) at completion of 8 weeks intervention, and (3) at three months follow-up | |
Secondary | Self Efficacy | Self Efficacy will be measured on Diabetes management self-efficacy scale (DMSES). DMSES is a self-administered scale used to assess subjects's perceived confidence in their ability to manage blood sugar, diet, physical activity and foot care. The scale comprises of 20 items. Each item's response is rated on 11 point scale ranging from 'cant do at all (0)' to 'certain can do it' (10) with total score 0 to 200. | Self Efficacy will be measured at three points in time (1) at baseline, (2) at completion of 8 weeks intervention, and (3) at three months follow-up | |
Secondary | Self Care Behaviors | Self Care Behaviors will be measured on Summary of diabetes self-care activities (SDSCA). SDSCA is a self-reported scale to measure self-care activities across diverse components of diabetes self-management. SDSCA comprises of 25 items with each item measuring the frequency of self-care activities by asking how often several self-care activities were carried out over past seven days period. Each item's response is rated on 7 point scale ranging from '0' to '7' with total score ranging from 0 to 175. A higher score would be the frequency of performing self-care activities. | Self care behaviors will be measured at three points in time (1) at baseline, (2) at completion of 8 weeks intervention, and (3) at three months follow-up |
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