Clinical trial NCT05491252: A Randomized Controlled Trial of Patient-Centered Self-Management Intervention in Adults With Type 2 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes, Self-management, Patient Centred Care, RCT
Lead sponsor: Shifa Tameer-e-Millat University
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 612
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In parallel arm design, subjects are randomized to one or more study arms and each study arm will be allocated a different intervention. After randomization each subject stays in their assigned treatment arm for the duration of the study. Subjects receive the same treatment throughout the trial. The results are then compared.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Glycemic Control (HbA1c)
timeFrame: 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 outcomes:
measure: Self Efficacy
timeFrame: 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
measure: Self Care Behaviors
timeFrame: 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
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: District Head Quarter (DHQ) Hospital
state: Punjab
city: Faisalābad
country: Pakistan
facility: Allied Hospital
state: Punjab
city: Faisalābad
country: Pakistan
facility: Government General Hospital
state: Punjab
city: Faisalābad
country: Pakistan
facility: Punjab Social Security Hospital
state: Punjab
Study officials:
affiliation: Shifa Tameer e Millat University, Islamabad, Pakistan
name: Khairunnisa Dhamani, PhD
role: STUDY_DIRECTOR
affiliation: Shifa Tameer-e-Millat University
name: Erika Froelicher, PhD
role: STUDY_DIRECTOR
affiliation: Shifa Tameer-e-Millat University
name: Raisa Gul, PhD
role: STUDY_DIRECTOR
References: