Improving Congenital Heart Disease Care

Официальное название

Improving Care for Adults With Congenital Heart Disease

Обзор

The theory-informed digital health intervention, called as "Empower My Congenital Health (EmpowerMyCH)" aims to activate and engage ACHD patients in building confidence toward navigating the adult healthcare system. This tool is built after incorporating the theories of behavior change, gathering inputs from target patients in all stages of its design and implementation. The key features of the tool include a digital medical passport, updated congenital information, community support, and patient stories and advice. The investigators aim to test the acceptability, feasibility, efficacy, and effectiveness of the intervention.

Подробное описание

The goal of this clinical trial study is to learn whether a digital multi-component intervention would increase the knowledge, self-efficacy, self-advocacy, and patient engagement skills of adults with congenital heart disease (CHD) to confidently navigate the health care system and have timely recommended specialist visits.

The multicomponent intervention contains features such as a digital medical passport, updated health-related specific information, opportunities to engage with CHD community, peer-support, doctor visit reminders, etc. The intervention components are designed with inputs from the patients and the CHD community and have the potential to be adapted on an ongoing basis depending on the needs of the patients.

The main question it aims to answer is:

Does the digital multi-component CHD patient engagement intervention enhance the patient engagement skills and lead to timely specialist visit?

Participants will be recruited from the clinics, through word of mouth, social media, and others. Participants can use the website link or a QR code to sign an electronic consent form to be eligible to participate. Once consented, the participants will receive surveys to collect baseline and health status information as well as intervention components at regular intervals. The study will be available for participants to join on the web or mobile, depending on their preferences.

Вмешательства

• Поведенческое Digital patient empowerment intervention
  The intervention has features such as a digital medical passport, updated health-related information, community support and patient/peer stories and advice

Первичные конечные точки

• Recruitment rate [Срок оценки: 6-12 months]
• Satisfaction with the intervention components [Срок оценки: 0, 6 and 12 months]
• Acceptability of the intervention components [Срок оценки: 0, 6 and 12 months]
• Feasibility of the intervention [Срок оценки: 0, 6 and 12 months]

Вторичные конечные точки (4)

• Patient activation measure (PAM) [Срок оценки: 0, 6, 12 months]
• Gothenburg Empowerment Scale (GES) [Срок оценки: 0, 6, 12 months]
• Timely specialist visit [Срок оценки: 24 - 36 months]
• Euro-Quality of Life [Срок оценки: 0, 6, 12, and 24 months]

Критерии участия

Критерии включения

• have congenital heart disease
• 18 years or older
• can sign the informed consent

Критерии исключения

• developmentally delayed
• unable to consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of California, San Francisco — San Francisco

Идентификаторы

NCT: NCT06581484 · K23HL151866 · K23HL151866

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗