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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 612
- 试验地点
- 8
- 主要终点
- Change in Glycemic Control (HbA1c)
研究概览
简要总结
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.
详细描述
Background: In Pakistan, the rising burden of type 2 Diabetes Mellitus (DM) and its associated complications is considerably affecting the functional capacity of the individuals, their quality of life and demand for healthcare services with significant economic impact on health care system and the national economy. Given its enormous 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 and minimize the risk of major complications thereby lowering health-care costs. Efective self-management on the other hand, demands patients' confidence and their full commitment to perform self care tasks necessitating a patient-centered approach.
Objective
To test the efficacy of a patient centered self-management intervention to improve glycemic control, self-efficacy and self-care behaviors in adults with type 2 DM.
Setting, Duration, Study Type: The study will be carried out as a randomized controlled trial (RCT) in four public tertiary care hospitals in Faisalabad, Pakistan.
Methods: A total 612 subjects will be recruited from out-patient departments (OPDs) of the study hospitals. Using random allocation 306 subjects will be assigned to the control group and 306 to the intervention group. Both the control group and the intervention group will receive usual care delivered at study hospitals. The intervention group will additionally receive a patient centered self-management Intervention for eight weeks duration.
Expected Outcome: If the study is able to show that the intervention group had improved glycemic control, self-efficacy and self-care behaviors than the control group. Then, employing hospital policies, this evidence-based care may be provided to all DM patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data Collectors / Outcome Assessors will be blinded of which treatment group subject is assigned to.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (aged 18 years or above)
- •Diagnosed with type 2 Diabetes Mellitus for at least 06 months duration.
- •Willing to participate in the study by signing of the consent form.
排除标准
- •Type 2 DM Patient with HbA1c < 7
- •Uncontrolled psychological comorbidity (psychosis, schizophrenia, dementia or severe learning difficulties).
- •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).
- •Life expectancy of less than six months as determined by patient's primary physician.
- •Living outside of Faisalabad City.
结局指标
主要结局
Change in Glycemic Control (HbA1c)
时间窗: 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
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.
次要结局
- Self Efficacy(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)
- Self Care Behaviors(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)
研究者
Kainat Asmat
Kainat Asmat
Shifa Tameer-e-Millat University