Effectiveness of a Telemedicine-Based Behavioral Intervention for Improving Self-Care Practice and Management Outcomes Among Hypertensive Patients Attending Tertiary Hospitals in Northwest Amhara: A Quasi-Experimental Study Intervention Protocol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 320
- 主要终点
- Self-care practice
研究概览
简要总结
The goal of this quasi-experimental clinical study is to learn whether a telemedicine-based behavioral intervention can improve self-care practices among adult patients with hypertension receiving care at teaching hospitals in Northwest Amhara.
The main questions it aims to answer are:
- Does a telemedicine-based intervention improve self-care practices among hypertensive patients?
- Does the intervention improve medication adherence among hypertensive patients?
- Does the intervention increase patients' knowledge about hypertension?
- Does the intervention reduce emergency hospital admissions among hypertensive patients? We will compare patients who receive telemedicine-based counseling with patients who receive usual care to see if the intervention improves self-care, medication adherence, knowledge, and reduces emergency admissions.
Participants will:
- Receive 10-15-minute telephone counseling sessions every two weeks for three months (intervention group only)
- Receive education on blood pressure monitoring, medication adherence, diet, physical activity, and stress management (intervention group only)
- Continue routine hypertension care at the hospital (both groups)
详细描述
Background Hypertension is a major cause of premature death worldwide. An estimated 1.4 billion adults aged 30-79 years worldwide had hypertension in 2024; this represents 33% of the population in this age range. Two-thirds of adults aged 30-79 years who have hypertension live in low- and middle-income countries. Previous meta-analysis showed that the pooled prevalence of hypertension in Ethiopia was 21.81%. The Digital Health Interventions (DHIs) for telemedicine/telehealth reduced office BP compared with usual care. In the US, Systematic reviews and meta-analyses find that digital health interventions, especially home BP telemonitoring with clinician feedback and medication titration, lower SBP by approximately 3-6 mmHg compared to usual care at 6-12 months.
Randomized control trial conducted in Japan revealed that telemedicine-based intervention was determined to be safe in managing hypertension, and the intervention group demonstrated a reduction in systolic blood pressure of 9.2 mmHg, whereas the reduction in the usual care group was 5.4 mmHg.
A systematic review and meta-analysis conducted in China showed that the group that used app-based mHealth was associated with better Blood Pressure control than the usual intervention group. Digital health interventions may be effective for Blood Pressure control, changes in lifestyle behaviors, and improvements in medication adherence in low and middle-income countries.
Regular phone-based intervention can enhance blood pressure control and improve medication adherence. The integration of digital health interventions with clinical management is crucial for achieving optimal clinical effectiveness in blood pressure control, lifestyle behavior modification, and medication adherence. The effect of telemedicine-based interventions on hypertension management outcomes remains uncertain in Ethiopia. Therefore, this protocol describes a structured telemedicine-based counseling intervention aimed at improving blood pressure control and medication adherence among hypertensive patients through remote behavioral support.
Study Design and Setting: A two-arm quasi-experimental design with two parallel groups and 1:1 allocation will be employed to evaluate the effect of telemedicine-based intervention on the outcomes of patients with hypertension. The study setting will be two teaching hospitals in Northwest Amhara, specifically
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Masking Description
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 patients ≥18 with hypertension who have follow-up for ≥6 months at the study settings
- •Have access to mobile or fixed telephones
- •Will stay for the study follow-up period
排除标准
- •Participants who have coexisting severe mental health illnesses
- •Severe hearing impairments
- •Pregnant will be excluded
研究组 & 干预措施
Telemedicine-Based Behavioral Intervention Arm
The intervention arm will receive a telemedicine-based behavioral intervention, including 10-15 minutes phone counseling sessions every 2 weeks for three months. Trained healthcare providers will educate patients on blood pressure monitoring, medication adherence, healthy diet, physical activity, stress management, and warning signs of complications. The intervention is designed based on literature and culturally appropriate practices. The control group will receive usual care without tailored support.
干预措施: Telemedicine-Based Behavioral Counseling (Behavioral)
Usual Care Control Arm
The control arm will receive standard hypertension care provided at the hospitals, which may include routine clinical visits, prescribed medications, and general health advice, but will not include the telemedicine-based counseling or tailored self-care support provided to the intervention group.
结局指标
主要结局
Self-care practice
时间窗: The intervention will be delivered over a period of three months, with participants in the intervention group receiving 10-15 minute telephone counseling sessions every two weeks. Assessments will be done at baseline and end of intervention.
Self-care practice will be measured using the Hypertension Self-Care Activity Level Effects (H-SCALE) instrument, which assesses adherence across six domains: medication, diet, physical activity, smoking, weight management, and alcohol use. Behaviors are evaluated over the past seven days, except weight management, which uses a five-point Likert scale. Each domain will be scored per standardized H-SCALE criteria and classified as good or poor. Medication adherence is good if all doses are taken daily. Diet is good if recommended practices are followed ≥6 days/week. Physical activity is good if ≥30 minutes are performed ≥5 days/week. Smoking is good if no smoking occurs. Weight management is good if the mean Likert score is ≥4. Alcohol use is good if consumed ≤1 day/week. A composite score sums the domains with good self-care. Participants achieving good self-care in ≥70% of domains will be classified as having overall good self-care practice.
次要结局
- Medication adherence(The intervention will be delivered over a period of three months, with participants in the intervention group receiving 10-15 minute telephone counseling sessions every two weeks. Assessments will be done at baseline and end of intervention.)
- Knowledge about hypertension life style management(The intervention will be delivered over a period of three months, with participants in the intervention group receiving 10-15 minute telephone counseling sessions every two weeks. Assessments will be done at baseline and end of intervention.)
- Hospital admission(The intervention will be delivered over a period of three months, with participants in the intervention group receiving 10-15 minute telephone counseling sessions every two weeks. Assessments will be done at baseline and end of intervention.)
研究者
Eyob Ketema Bogale
Principal Investigator
Bahir Dar University