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临床试验/NCT07145983
NCT07145983已完成不适用

Peer Support Intervention Effect on Medication Adherence, Self-care and Knowledge Among Patients With Diabetes: A Randomized Control Trial

Addis Ababa University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年12月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Medication Adherence status

研究概览

简要总结

The goal of this interventional study is to learn about the effect of a peer support group intervention on adherence, self-care practice, and knowledge among diabetic patients on follow-up care. The main question it aims to answer is:

  • Does participation in a peer support group improve medication adherence, self-care behaviors, and diabetes knowledge compared to standard care?
  • Participants with diabetes who are already receiving follow-up care at Ayder Comprehensive Specialized Hospital(ACSH) will be randomly assigned to either a peer support group (intervention group) or continue their usual follow-up care (control group). Outcomes will be measured through validated questionnaires and pill counts over the study period.

详细描述

BACKGROUND Diabetes mellitus (DM) is a chronic metabolic disorder that comes as one of the fastest-growing global health challenges, with the number of affected individuals projected to reach 643 million by 2030 and 783 million by 2045. Sub-Saharan Africa is experiencing a rapid rise in DM prevalence, partly due to urbanization, lifestyle changes, and limited access to preventive and treatment services. In Ethiopia, diabetes contributes substantially to the burden of non-communicable diseases, yet many patients fail to achieve optimal glycemic control.

Peer support is considered a promising, feasible, and culturally appropriate enhancement to diabetes care, enabling participants to assist one another in their ongoing self-management efforts. It is effective in preventing the complications of diabetes and enhancing health outcomes in patients with diabetes. Previous systematic reviews have reported that programs were effective for diabetes outcomes, including glycemic control, knowledge of diabetes, self-management skills, and self-efficacy. A healthy lifestyle, an appropriate diet, and medication adherence among diabetic patients are essential factors in the prevention of diabetes complications as well as maintaining good glycemic control. However, many patients with diabetes fail to manage the disease due to its complex nature. Hence, patients with diabetes need self-management education to assist them in comprehending and dealing with the disease.

Several rigorous reviews have demonstrated that adherence to treatment among patients with chronic diseases in developed countries is about 50%. Considering the scarcity and inequities in access to healthcare services in developing countries, this rate is assumed to be even lower. Poor adherence to diabetes medications is common among African Americans and contributes to these disproportionally worse outcomes. Numerous studies suggested that diabetic peer support programs have positive outcomes on improvement of adherence to medication which is essential for successful diabetes management. For example, Shiyanbola and coworker supported that conduction of an efficacy trial to address medication adherence using a peer-supported tailored intervention is essential. The healthcare effectiveness report from united states (US) point out that inadequate medication adherence is one of the main causes of the differences in glycemic control attainment rates between real-world settings and randomized controlled trials, which emphasizes the need for better provider and patient support programs to improve adherence. Thus, Patient support programs can improve persistence with and/or adherence to medications for the treatment of chronic diseases like diabetes.

Sub-Saharan Africa researches have demonstrated that peer support programs are beneficial and enable participants to modify their lifestyle and adhere to treatment. A study conducted in Uganda showed that improvements in eating habits, diastolic blood pressure, and glycosylated hemoglobin (HbA1c), after peer support program had carried out to diabetic patients and concluded that as it is a workable intervention to enhance diabetes care in health care settings. Additionally, diabetes peer support programs have been demonstrated to enhance patients' health-related behaviors, metabolic management, and quality of life in nations such as South Africa, and Cameroon. After the diabetes peer support program has positively impacted its members in Malawi, the researchers suggested that additional recruitment and ongoing training for peer supporters is necessary to reinforce and update management knowledge and skills. Besides, they concluded that it is a viable strategy for the non-communicable diseases unit within the Ministry of Health. In Ethiopia, fewer than 50% of diabetic individuals obtain proper diabetes care.

Despite the empirical studies showing positive and significant relationships between diabetes peer support and treatment adherence among patients with diabetes, the exact mechanism by which peer support affects patient adherence is not yet completely understood. Further research is needed to address how the differences in types of support, such as functional or emotional support, are linked to outcomes for patients. Specifically, there remains a gap in understanding what constitutes peer support and how to effectively implement it in low-resource environments, like Ethiopia health care settings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clincal Diagnosis of Diebetes mullites's Disease
  • Must be on at least one diabetes medication
  • Must had at least two concicative follow-up visits at the Diabetes clinic

排除标准

  • Declined to participate in any of the group
  • Concurrent endocrine disorders (thyroid disease, obesity, or gestational diabetes)
  • Chronic diseases (cardiac heart failure, hepatitis and cancer)
  • Enrollement in other educational programs during the study period those who
  • Health professionals with diabetes

研究组 & 干预措施

Intervention Group

Experimental

Participants receive peer-led support sessions in addition to usual diabetes care.

干预措施: Structured Diabetes Education on medication Adherence and self care (Behavioral)

No-Intervention Comparator: Standard Care Alone(Control group)

No Intervention

Participants continue with routine follow-up and standard diabetes care only.

结局指标

主要结局

Medication Adherence status

时间窗: Baseline and 6 months

Medication adherence of each group was assessed through a mixed method using the Morisky Medication Adherence Scale (MMAS-8) and self-reported pill count. The Morisky Medication Adherence Scale consisted of seven dichotomous items and one item rated on a five-point Likert scale which provided five response options, scored from 0 to 1 in 0.25-point increments. Based on the total score, patients were classified as low adherers (score \<6), medium adherers (score 6 to \<8),or high adherers (score = 8). Pill count data were obtained at each assessment round to evaluate actual medication use. Adherence was calculated by subtracting the number of pills remaining from the quantity dispensed, dividing the result by the product of the prescribed daily dose and the number of days since the last refill, and then multiplying by 100 to obtain a percentage. Patients with adherence below 80% were classified as Poor adherent, and those with above 80% were classified as Good adherent.

Medication Adherence Status

时间窗: Baseline and 6 months

Medication adherence of each group was assessed through a mixed method using the Morisky Medication Adherence Scale (MMAS-8) and self-reported pill count. The Morisky Medication Adherence Scale consisted of seven dichotomous items and one item rated on a five-point Likert scale which provided five response options, scored from 0 to 1 in 0.25-point increments. Based on the total score, patients were classified as low adherers (score \<6), medium adherers (score 6 to \<8),or high adherers (score = 8).

Overall Diabetes Self-Care Practice Score

时间窗: Baseline and 6 months

Overall diabetes self-care practice was assessed using a standardized self-care questionnaire covering multiple domains, including general diet, specific diet, physical activity, blood glucose monitoring, foot care, and adherence to health care provider recommendations. A composite self-care practice score was calculated and participants were categorized as having good self care practice if a mean scored of 3.5 and greater days per week and poor self-care practice if mean scored less than 3.5days per week.The higher scores mean a better outcome.

Diabetes Knowledge Status

时间窗: Baseline and 6 months

Diabetes-related knowledge was assessed using a validated instrument designed to measure patients' knowledge related to diabetes management. The questionnaire included 14 core items administered to all participants. An additional 9 items were administered to insulin users, resulting in a total possible score ranging from minimum(0)to Maximum score (14) for non-insulin users and minimum(0) to maximum(23) for insulin users. Each correct response was assigned one point, and item scores were summed to generate a total diabetes knowledge score. Higher scores indicate better diabetes-related knowledge. For interpretation, participants scoring at least 50% of the maximum possible score for their respective category (≥7 for non-insulin users and ≥11.5 for insulin users) were classified as having good diabetes-related knowledge, while those scoring less than 50% were classified as having poor diabetes-related knowledge.T

次要结局

  • Medication Adherence Status by Pill Count(Baseline and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Halefom Kahsay Haile

Mr

Addis Ababa University

研究点 (1)

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