The Feasibility of an Intervention Targeting Sources of Meaning in Cardiac Rehabilitation

Обзор

Being diagnosed with heart disease can be a life-changing experience, often sparking existential questions and concerns about meaning in life. A lack of meaning in life has been found associated with increased emotional distress and decreased quality of life. Health professionals recognize that issues related to personal meaning in life are relevant but rarely address these aspects systematically in cardiac rehabilitation. This may be due to a lack of necessary tools. The project evaluates a novel, brief and structured intervention that aims to strengthen the experience of meaningfulness and reduce or prevent emotional distress by addressing personal sources of meaning in life among patients attending cardiac rehabilitation and their relatives in Denmark. The intervention is based on the Sources of Meaning Card Method, a method developed by Peter la Cour and Tatjana Schnell to map and explore personal sources of meaning (www.somecam.org). For the current project, the method has been adapted for a cardiac rehabilitation context. Three intervention formats are examined in a feasibility study in a municipal rehabilitation setting: 1) an individual format for patients in cardiac rehabilitation, 2) a dyadic format including a patient together with a relative, and 3) a group format for patients. Approximately 60 patients and 20 relatives are expected to participate. The study explores (a) participants' experience with and acceptability of the intervention formats; (b) changes in meaningfulness and emotional distress in a pre-post design; (c) recruitment and adherence rate, and (d) acceptability and practicality of the three formats among rehabilitation professionals.

Вмешательства

• Другое Conversation on Sources of Meaning in life with heart disease
  The intervention uses the brief and structured Sources of Meaning Card Method (SoMeCaM; www.somecam.org), which has been adapted for use in cardiac rehabilitation. It explores personal sources of meaning in a conversation with one patient in a 1-hour session. It comprises 26 cards each including statements on a particular source of meaning. The patient prioritizes the cards, reflects on them, and identifies possibilities for change. The conversation is facilitated by a professional (trained mas
• Другое Group based session on Sources of Meaning in life with heart disease
  The intervention is based on the brief and structured Sources of Meaning Card Method (SoMeCaM; www.somecam.org), which has been adapted for use in groups in a cardiac rehabilitation context. The method uses 26 cards, each representing a specific source of meaning. Approximately 6-10 participants are guided through a process of individually prioritizing the cards, reflecting on them and identifying potential areas for change or development in smaller groups. The group-based format enables mutual
• Другое Dyadic Conversation on Sources of Meaning in Life with heart disease
  The intervention is based on the brief and structured Sources of Meaning Card Method (SoMeCaM; www.somecam.org), which has been adapted for use in dyads in a cardiac rehabilitation context. The method uses 26 cards, each representing a specific source of meaning. The dyadic format considers both the patient's and the relative's individual and shared sources of meaning in 1 session, which may enhance understanding for each other's sources of meaning and facilitate their joint daily life. They bot

Первичные конечные точки

• Participants' experiences with the three intervention formats [Срок оценки: Approximately 1 month post intervention]
• Theoretical Framework of Acceptability (TFA) Questionnaire [Срок оценки: 1 month post intervention]
• Acceptability of the three intervention formats among participants [Срок оценки: Approximately 1 month post intervention]
• Changes in symptoms of depression [Срок оценки: Baseline, 1 month post intervention and 3 months post intervention]
• Changes in symptoms of anxiety [Срок оценки: Baseline, 1 month post intervention and 3 months post intervention]
• Changes related to meaning in life [Срок оценки: Baseline, 1 month post intervention and 3 months post intervention]
• Recruitment rate [Срок оценки: From study start until recruitment ends (approximately 1 year)]
• Intervention adherence [Срок оценки: Through study completion, approximately 1 year]
• Study attrition (dropout rate) [Срок оценки: Through study completion (approximately 15 months from study start)]
• Acceptability among rehabilitation professionals [Срок оценки: After study enrollment (approximately 1 year from study start)]

Вторичные конечные точки (8)

• Changes in health-related quality of life [Срок оценки: Baseline, 1 month post intervention and 3 months post intervention]
• Changes in awareness on sources of meaning in everyday life. [Срок оценки: Baseline, 1 month post intervention and 3 months post intervention]
• Changes in engagement in sources of meaning in everyday life [Срок оценки: Baseline, 1 month post intervention and 3 months post intervention]
• Changes in mutual understanding (dyadic intervention arm) [Срок оценки: Baseline, 1 month post intervention and 3 months post intervention]
• Changes in relationship quality (dyadic intervention arm) [Срок оценки: Baseline, 1 month post intervention and 3 months post intervention]
• Intervention costs [Срок оценки: Through study completion (approximately 1 year post study start)]
• Reasons for dropout [Срок оценки: At time of dropout (Up to 4 months post intervention)]
• Engagement in intervention [Срок оценки: 1 month post intervention]

Критерии участия

A.

Inclusion criteria, individual and group-based intervention formats:

• ≥18 years of age
• attending municipal cardiac rehabilitation
• proficiency in Danish

Exclusion criteria, individual and group-based intervention formats:

• severe psychiatric disorder
• severe cognitive impairment

B. Inclusion criteria, patients in dyadic intervention format

• as in A
• and having a relative who would like to participate

Inclusion criteria, relative in dyadic intervention format:

• ≥18 years of age
• relative to a patient attending municipal cardiac rehabilitation
• proficiency in Danish

Exclusion criteria, patient and relative dyadic intervention format

\- as in A

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Дания · 2 центра

• Center for Sundhed og Forebyggelse — Odense
• Sundhedskurser, Sundhedshus Vejle — Vejle

Идентификаторы

NCT: NCT07262580 · REC610 · Grant no. 2023-12404

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗