To Test an e-Health Educational Intervention Patients With an ICD

Официальное название

To Co-develop and Test an eHealth Intervention to Improve Knowledge, Attitude and Experience in Patients Living With an Implantable Cardioverter Defibrillator

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Choice-ICD
  The eHealth intervention theoretically driven, interactive and provides personalised information to patients and family members when and where they wish to access it. Five short (2-3 minutes) videos, involving patients, caregivers and professionals, are uploaded onto the APP, alongside animation clips and useful links to online resources. A discussion forum will be accessible for participants using the APP, which will be closely moderated by the researcher, who will ensure any concerning posts o

Первичные конечные точки

• Feasibility, acceptability and usability of the Choice-ICD intervention [Срок оценки: 3 and 6 months after recruitment.]

Вторичные конечные точки (7)

• Patients' perceptions pre and post intervention [Срок оценки: Baseline, 3 months and 6 months.]
• Patients' concerns regarding the ICD pre and post intervention [Срок оценки: Baseline, 3 months and 6 months.]
• Patients' knowledge, experience and attitudes pre and post intervention [Срок оценки: Baseline, 3 months and 6 months.]
• Patients' anxiety pre and post intervention [Срок оценки: Baseline, 3 months and 6 months.]
• Patients' acceptance of the ICD pre and post intervention [Срок оценки: Baseline, 3 months and 6 months.]
• Patients' quality of life pre and post intervention [Срок оценки: Baseline, 3 months and 6 months.]
• Caregiver burden pre and post intervention [Срок оценки: Baseline, 3 months and 6 months.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Великобритания · 2 центра

• Belfast Health and Social Care Trust — Belfast
• Golden Jubilee National Hospital — Glasgow

Идентификаторы

NCT: NCT06667505 · 24/NI/0094 · FS/CDRF/22/21048

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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