Effectiveness of Mobile-Based Telemedicine on Health-Related Quality of Life Among Patients With Chronic Heart Failure: Protocol for a Quasi-Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Health-Related Quality of Life (HRQoL)
研究概览
简要总结
Chronic heart failure (CHF) is a long-term condition in which the heart is unable to pump blood effectively. It can cause symptoms such as shortness of breath, fatigue, swelling in the legs, and reduced ability to perform daily activities. These problems often reduce a patient's quality of life and may lead to frequent hospital visits.
This study will assess whether a mobile-based telemedicine program can improve the health-related quality of life of patients with chronic heart failure in Ethiopia.
In this study, 70 adult patients with chronic heart failure will be included. They will be divided into two groups: 35 patients will receive routine care plus mobile-based telemedicine support, and 35 patients will receive routine care only.
The mobile-based telemedicine program will include health education, medication reminders, lifestyle advice, and follow-up support delivered through phone calls and text messages over an 8-week period.
Patients' quality of life will be measured at the beginning of the study and again after 8 weeks using a standard questionnaire called the Minnesota Living with Heart Failure Questionnaire (MLHFQ).
The main goal of the study is to determine whether mobile-based telemedicine improves quality of life compared with routine care alone. The study may also help improve self-care behaviors, medication adherence, and symptom control among patients with heart failure.
The findings may provide evidence to support the use of mobile health technologies as a simple and scalable approach to improve heart failure care in Ethiopia.
详细描述
Chronic heart failure (CHF) is a long-term cardiovascular condition that significantly impairs functional capacity and quality of life. Patients often experience persistent symptoms, reduced daily activity, and frequent hospital visits, particularly in settings with limited access to continuous follow-up care.
This study will evaluate the effectiveness of a mobile-based telemedicine intervention on health-related quality of life among CHF patients attending follow-up care at Menelik II Comprehensive Specialized Hospital, Addis Ababa, Ethiopia.
A quasi-experimental design with a nonequivalent control group pre-test and post-test approach will be used. A total of 70 eligible adult CHF patients will be included and assigned to either an intervention group (n = 35) or a comparison group (n = 35).
The intervention group will receive an 8-week mobile-based telemedicine program in addition to routine care. The program includes scheduled phone calls, text messages, and WhatsApp-based communication providing education, self-care guidance, medication adherence support, lifestyle modification advice, and symptom monitoring. The comparison group will receive routine standard care only.
Health-related quality of life will be measured at baseline and after 8 weeks using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The main outcome is the change in HRQoL between the two groups after the intervention period.
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
- None
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
- 否
入选标准
- •Adults aged 18-65 years who will be diagnosed with CHF (NYHA class II⁃III)
- •Patients with reduced left ventricular ejection fraction LVEF ≤ 40%
- •Patient who will have access to a mobile phone and will be able to use it
- •Patients who will be able to communicate in Amharic, Oromic, or English
- •Patients who will provide written informed consent
- •Patients who will be diagnosed with HF lasting ≥ 6 months, to be confirmed by echocardiography and clinical assessment
- •Patients with no contraindications for mild to moderate physical activity
排除标准
- •Patients with NYHA class IV or who will require intensive care at enrollment
- •Patients with other severe medical conditions (e.g., end-stage renal disease, & end stage liver disease)
- •Patients with severe cognitive impairment or psychiatric illness that will interfere with participation
- •Patients already enrolled in another telemedicine or intervention study
- •Pregnant and lactating women
研究组 & 干预措施
Mobile-Based Telemedicine + Routine Care
Arm 1 Arm Name: Intervention Group (Mobile-Based Telemedicine + Routine Care)
Description:
Participants in this arm will receive routine heart failure care provided at the cardiac clinic in addition to an 8-week mobile-based telemedicine intervention.
Intervention(s):
Behavioral Intervention: Mobile-Based Telemedicine Scheduled mobile phone calls SMS/text messages WhatsApp-based educational messages Health education on heart failure management Medication adherence support Diet and lifestyle counseling Symptom monitoring and follow-up support
干预措施: Supportive Care (Other)
Routine Care Only
Arm 2 Arm Name: Control Group (Routine Care)
Description:
Participants in this arm will receive standard routine heart failure care provided at the cardiac clinic without additional mobile-based telemedicine support.
Intervention(s):
Standard Clinical Care Routine follow-up visits Usual medical management for chronic heart failure
干预措施: Supportive Care (Other)
结局指标
主要结局
Health-Related Quality of Life (HRQoL)
时间窗: Baseline and 8 weeks after intervention
Health-related quality of life will be assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The MLHFQ is a 21-item validated disease-specific instrument for patients with chronic heart failure. Each item is rated on a 6-point Likert scale ranging from 0 (no impact) to 5 (very much impact), with total scores ranging from 0 to 105. Lower scores indicate better quality of life. The primary outcome will be the change in MLHFQ total score from baseline to 8-week follow-up between the intervention and control groups.
次要结局
未报告次要终点
研究者
Gudisa Bereda
Principal Investigator
Select College