Evaluation of the Feasibility, Usability, and Preliminary Effects of an mHealth Intervention Complementary to Usual Care in Individuals With Heart Failure: Protocol for a Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Retention rate
研究概览
简要总结
This study is a pilot randomized controlled trial designed to evaluate the feasibility, acceptability, usability, and preliminary efficacy of a mobile health (mHealth) educational self-management intervention for individuals with heart failure during the transition from hospital to home. Participants will be randomly assigned in a 1:1 ratio to receive either usual care alone or usual care plus the mHealth intervention.
The mobile application is designed to support heart failure self-care through tailored educational content, symptom self-monitoring, automated feedback, behavioral reinforcement messages, caregiver involvement, and secure communication with the healthcare team. The application is educational in nature and does not replace standard medical treatment.
A total of 30 participants will be enrolled and followed for 60 days after hospital discharge, with outcome assessments conducted at 30 and 60 days. Primary outcomes focus on feasibility, technology acceptance, and usability of the intervention. Secondary exploratory outcomes include changes in self-care behaviors, functional status, heart failure related hospital readmissions and natriuretic peptide levels. Results from this pilot study will inform the design of a future definitive randomized controlled trial.
详细描述
This is an interventional, randomized, controlled, parallel-group pilot trial with a 1:1 allocation ratio designed to evaluate the feasibility, acceptability, usability, and preliminary efficacy of a mobile health (mHealth) educational self-management intervention for individuals with heart failure during the hospital-to-home transition. The study uses a single-blind design in which outcome assessors are blinded to group assignment. The intervention is behavioral and educational in nature; therefore, the study phase is classified as not applicable.
The study will be conducted at a tertiary cardiovascular referral institution. Participants will be recruited from inpatient cardiology services prior to hospital discharge and followed for 60 days after hospital discharge, with outcome assessments conducted at 30 and 60 days.
Eligible participants include adults aged 18 years or older with a diagnosis of heart failure (New York Heart Association class II or III), who are clinically stable at discharge, own a compatible smartphone, demonstrate basic digital literacy, and have an informal caregiver willing to support the intervention. Key exclusion criteria include life expectancy less than 6 months, severe cognitive impairment, inability to provide informed consent, or participation in another interventional study.
Participants will be randomly assigned (1:1) using computer-generated block randomization with variable block sizes of 4 and 6. The allocation sequence will be generated by an independent researcher not involved in recruitment or outcome assessment. Allocation concealment will be ensured through sequentially numbered, opaque, sealed envelopes.
Two study arms are defined:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to group allocation. Due to the nature of the intervention, participants and care providers cannot be blinded.
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
- •Age ≥ 18 years
- •Diagnosis of heart failure (NYHA Class II or III)
- •Clinically stable at discharge (no IV inotropes within 48 hours; hemodynamically stable)
- •Ownership of compatible smartphone (Android/iOS)
- •Basic digital literacy
- •Availability of informal caregiver willing to support the process
排除标准
- •Life expectancy < 6 months
- •Severe cognitive impairment (MMSE <24 or documented dementia)
- •Inability to provide informed consent
- •Participation in another interventional study
研究组 & 干预措施
Usual Care
Participants will receive standard hospital to home transitional care, including multidisciplinary discharge education, medication reconciliation, and scheduled outpatient follow-up according to institutional protocols.
干预措施: Usual transitional care (Other)
mHealth educational self-management intervention
Participants will receive a mobile health (mHealth) educational self-management intervention in addition to usual care. The intervention consists of a mobile application designed to support heart failure self-care through tailored educational modules, symptom self-monitoring, automated feedback, behavioral reinforcement messages, caregiver integration, and secure communication with the healthcare team over a 60-day period following hospital discharge.
干预措施: mHealth Educational Self-Management Application (Behavioral)
结局指标
主要结局
Retention rate
时间窗: 30 and 60 days post-discharge
Proportion of randomized participants who complete follow-up assessments
Recruitment rate
时间窗: From screening until completion of recruitment
Proportion of eligible participants who are enrolled and randomized in the trial
Adherence to the mHealth intervention
时间窗: 30 and 60 days post-discharge
Proportion of educational modules completed and symptom self-monitoring entries recorded in the application logs.
Data completeness
时间窗: 30 and 60 days post-discharge
Percentage of completed outcome assessments among enrolled participants
Time required for enrollment and intervention delivery
时间窗: At enrollment
Time required to complete enrollment procedures and initial intervention delivery, measured in minutes.
次要结局
- Technology Acceptance of the Mobile Application (TAM)(60 days post-discharge)
- Usability of the Mobile Application(30 days post-discharge)
- Change in Self-Care (SCHFI v7.2)(Baseline, 30 days and 60 days post-discharge)