To Co-develop and Test an eHealth Intervention to Improve Knowledge, Attitude and Experience in Patients Living With an Implantable Cardioverter Defibrillator
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 256
- 试验地点
- 2
- 主要终点
- Feasibility, acceptability and usability of the Choice-ICD intervention
研究概览
简要总结
Role of the implantable cardioverter defibrillator (ICD) is to monitor heart rate and discharge a small electrical discharge or shock if the heart rate becomes life threatening. Patients and family members have requested more information about their ICD, how it works and how to live well with the device. This study will build on previous research by designing, in collaboration with patients, family members and professionals, an online resource to provide important information that can lower anxiety and concerns, and improve quality of life. The CHOICE-ICD resource will be easy to use, incorporating games and quizzes to encourage engagement, up to date information appropriate to each patient's needs, as well as animation clips, virtual reality, and short patient videos. CHOICE-ICD will be made available to 64 patients, in addition to normal care, awaiting or with a recently implanted ICD in Belfast and Glasgow. Patients will use the resource for 3 months. Patients and family members will then be asked to complete questionnaires and participate in semi-structured interviews. This study will develop 1st UK online resource providing information to enable patients to have greater choice and control in their care.
详细描述
Implantable cardioverter defibrillator (ICD) is cornerstone in treatment of life-threatening arrhythmias, yet 25% of patients express concerns following implantation.
Aim: To co-design, optimize and establish feasibility and acceptability of eHealth intervention: CHOICE-ICD, providing information to reduce patients' concerns and improve quality of life.
Methods: Phase 1 has been completed: Underpinned by theory and research, core components of an intervention has been co-designed according to six-step process, and in collaboration with stakeholders. Components include ICD written information, educational animations, virtual reality application and patient videos. International advisory group will oversee iterative development, user testing and optimization.
Phase 2 ongoing: CHOICE-ICD is pilot trial, recruiting 128 patients awaiting/recently implanted ICD or cardiac resynchronisation therapy with ICD from Northern Ireland and Glasgow. Participants will use the intervention for 3 months. Data will be analyzed to determine feasibility and acceptability of intervention, and trial methods for future effectiveness trial.
Outcomes: Recruitment, consent and randomization rates, and completion of questionnaires at baseline, 3 and 6 months. Acceptability of intervention delivery and suitability of outcome measures.
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
- None
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
- •Patients with heart failure awaiting or with an ICD (no time restriction on implantation)
- •No cognitive impairment
- •Caregivers:
- •Have contact with the patient at least 5 times per week.
- •Be physically and mentally capable of participation (self-assessment)
- •Healthcare professionals:
- •Daily care of patients with heart failure and an implantable cardioverter defibrillator
- •Involved in the care of a patient using the Choice-ICD intervention
排除标准
- •Patients, judged by their Cardiologist as physically or mentally unsuitable to complete the study.
- •Patients or caregivers lacking capacity to give consent.
- •Patients who have known pregnancy
- •Caregivers who's patient is unwilling to take participate
研究组 & 干预措施
Control
Patients will receive information booklet, that they would have received if they had not been included in this research
CHOICE-ICD
Patients will receive access to the CHOICE-ICD App for 3 months. They will also be provided with the information booklet, similar to usual care group
干预措施: Choice-ICD (Behavioral)
结局指标
主要结局
Feasibility, acceptability and usability of the Choice-ICD intervention
时间窗: 3 and 6 months after recruitment.
System Usability Scale and focus group. The system usability scale has 10 questions, with responses on a Likert scale 1(strongly disagree) to 5 (strongly agree). The higher the score the more feasible. The focus group will be completed at 6 months.
次要结局
- Caregiver burden pre and post intervention(Baseline, 3 months and 6 months.)
- Patients' quality of life pre and post intervention(Baseline, 3 months and 6 months.)
- Patients' perceptions pre and post intervention(Baseline, 3 months and 6 months.)
- Patients' concerns regarding the ICD pre and post intervention(Baseline, 3 months and 6 months.)
- Patients' knowledge, experience and attitudes pre and post intervention(Baseline, 3 months and 6 months.)
- Patients' anxiety pre and post intervention(Baseline, 3 months and 6 months.)
- Patients' acceptance of the ICD pre and post intervention(Baseline, 3 months and 6 months.)
研究者
Loreena Hill
Principal Investigator
University of Ulster