The Feasibility of an Intervention Targeting Sources of Meaning in Cardiac Rehabilitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conversation on Sources of Meaning in life with heart disease, Group based session on Sources of Meaning in life with heart disease, Dyadic Conversation on Sources of Meaning in Life with heart disease.
- Who it may be relevant to
- Registry conditions: Heart Disease, Mental Health Outcomes, Rehabilitation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other 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 - Other 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 - Other 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
Primary outcome measures
- Participants' experiences with the three intervention formats [Time frame: Approximately 1 month post intervention]
- Theoretical Framework of Acceptability (TFA) Questionnaire [Time frame: 1 month post intervention]
- Acceptability of the three intervention formats among participants [Time frame: Approximately 1 month post intervention]
- Changes in symptoms of depression [Time frame: Baseline, 1 month post intervention and 3 months post intervention]
- Changes in symptoms of anxiety [Time frame: Baseline, 1 month post intervention and 3 months post intervention]
- Changes related to meaning in life [Time frame: Baseline, 1 month post intervention and 3 months post intervention]
- Recruitment rate [Time frame: From study start until recruitment ends (approximately 1 year)]
- Intervention adherence [Time frame: Through study completion, approximately 1 year]
- Study attrition (dropout rate) [Time frame: Through study completion (approximately 15 months from study start)]
- Acceptability among rehabilitation professionals [Time frame: After study enrollment (approximately 1 year from study start)]
Secondary outcome measures (8)
- Changes in health-related quality of life [Time frame: Baseline, 1 month post intervention and 3 months post intervention]
- Changes in awareness on sources of meaning in everyday life. [Time frame: Baseline, 1 month post intervention and 3 months post intervention]
- Changes in engagement in sources of meaning in everyday life [Time frame: Baseline, 1 month post intervention and 3 months post intervention]
- Changes in mutual understanding (dyadic intervention arm) [Time frame: Baseline, 1 month post intervention and 3 months post intervention]
- Changes in relationship quality (dyadic intervention arm) [Time frame: Baseline, 1 month post intervention and 3 months post intervention]
- Intervention costs [Time frame: Through study completion (approximately 1 year post study start)]
- Reasons for dropout [Time frame: At time of dropout (Up to 4 months post intervention)]
- Engagement in intervention [Time frame: 1 month post intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Denmark · 2 centers
- Center for Sundhed og Forebyggelse — Odense
- Sundhedskurser, Sundhedshus Vejle — Vejle
Identifiers
NCT: NCT07262580 · REC610 · Grant no. 2023-12404