The Feasibility of an Intervention Targeting Sources of Meaning in Cardiac Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Recruitment rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Inclusion criteria, individual and group-based intervention formats:
- •≥18 years of age
- •attending municipal cardiac rehabilitation
- •proficiency in Danish
排除标准
- •, individual and group-based intervention formats:
- •severe psychiatric disorder
- •severe cognitive impairment
- •B. Inclusion criteria, patients in dyadic intervention format
- •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
研究组 & 干预措施
a) Individual intervention format
1:1 conversation between a professional and a patient in rehabilitation.
干预措施: Conversation on Sources of Meaning in life with heart disease (Other)
b) Dyadic (patient-relative) intervention format
The patient participates together with a relative and a professional.
干预措施: Dyadic Conversation on Sources of Meaning in Life with heart disease (Other)
c) Group based intervention format
A group-based approach, where approximately 6-10 patients in rehabilitation meet for a group session.
干预措施: Group based session on Sources of Meaning in life with heart disease (Other)
结局指标
主要结局
Recruitment rate
时间窗: From study start until recruitment ends (approximately 1 year)
Recruitment rate is defined as the proportion of participants who consented to participate in the study, reported as a percentage over the recruitment period.
Intervention adherence
时间窗: Through study completion, approximately 1 year
The proportion of participants who completed the full intervention, defined as participation in the one-session Sources of Meaning conversation (individual, patient-relative, or group-based) and the follow-up phone call. Data will be recorded by the research team.
Practicality of the intervention formats among rehabilitation professionals
时间窗: After study enrollment (approximately 1 year from study start)
Defined as the rehabilitation professionals' evaluation of whether the intervention can be successfully used in practice (municipal cardiac rehabilitation). Including factors such as time, resources, and workflow compatibility. Explored via focus group with professionals in the municipal cardiac rehabilitation.
Participants' experiences with the three intervention formats
时间窗: Approximately 1 month post intervention
Defined as the participants' experiences with their participation in one of the three intervention formats. Explored via focus groups and semi structured interviews.
Theoretical Framework of Acceptability (TFA) Questionnaire
时间窗: 1 month post intervention
Participants' acceptability of the intervention will be quantitatively assessed using the Theoretical Framework of Acceptability (TFA) Questionnaire. This scale evaluates the following seven constructs: affective attitude, burden, ethicality, opportunity costs, perceived effectiveness, self-efficacy, and intervention coherence. Each item is rated on a 5-point Likert scale ranging from 1 to 5. Higher scores indicate greater acceptability of the intervention across the measured domains.
Acceptability of the three intervention formats among participants
时间窗: Approximately 1 month post intervention
Acceptability will be explored qualitatively via focus groups and semi-structured interviews with participants enrolled in one of the three intervention formats
Changes in symptoms of depression
时间窗: Baseline, 1 month post intervention and 3 months post intervention
The Patient Health Questionnaire 9-item depression scale (PHQ-9) will be used to assess symptoms of depression in the past two weeks. Each item is scored 0 to 3. The severity score can range from 0 to 27, with higher scores indicating more severe symptoms.
Changes in symptoms of anxiety
时间窗: Baseline, 1 month post intervention and 3 months post intervention
The 7-item General Anxiety Disorder Scale (GAD-7) will be used to measure symptoms of anxiety in the past two weeks. Each item is scored 0 to 3, providing a 0 to 21 severity score, with higher scores indicating more severe symptoms.
Changes related to meaning in life
时间窗: Baseline, 1 month post intervention and 3 months post intervention
Changes in participants' self-reported experience of meaning in life will be assessed using two validated subscales from the Sources of Meaning and Meaning in Life Questionnaire: the Meaningfulness and Crisis of Meaning subscales. Each subscale consists of 5 items, scored on a Likert scale from 0 (Strongly disagree) to 5 (Strongly agree). For the Meaningfulness subscale, higher scores indicate a stronger sense of meaning in life. For the Crisis of Meaning subscale, higher scores indicate a stronger experience of life as empty, pointless and lacking of meaning.
Recruitment rate
时间窗: From study start until recruitment ends (approximately 1 year)
Recruitment rate is defined as the proportion of participants who consented to participate in the study, reported as a percentage over the recruitment period.
Intervention adherence
时间窗: Through study completion, approximately 1 year
The proportion of participants who completed the full intervention, defined as participation in the one-session Sources of Meaning conversation (individual, patient-relative, or group-based) and the follow-up phone call. Data will be recorded by the research team.
Study attrition (dropout rate)
时间窗: Through study completion (approximately 15 months from study start)
The proportion of participants who drop out from the study before completing all parts of the intervention, the 3 surveys and focus group and/or individual interview. Dropout will be assessed via administrative data.
Acceptability among rehabilitation professionals
时间窗: After study enrollment (approximately 1 year from study start)
Acceptability of the three intervention formats will be explored via focus groups with rehabilitation professionals involved in cardiac rehabilitation. The focus groups will address professionals' views on the interventions and perceived usefulness of the intervention in the municipal cardiac rehabilitation setting.
Practicality of the intervention formats among rehabilitation professionals
时间窗: After study enrollment (approximately 1 year from study start)
Defined as the rehabilitation professionals' evaluation of whether the intervention can be successfully used in practice (municipal cardiac rehabilitation). Including factors such as time, resources, and workflow compatibility. Explored via focus group with professionals in the municipal cardiac rehabilitation.
Intervention facilitators' experience with delivering the intervention
时间窗: Through study completion (approximately 1 year from study start)
Intervention facilitators will document their experience using semi-structured worksheets with field notes completed after each intervention session. These will capture reflections on feasibility, participant responsiveness, and challenges encountered in each step of the intervention.
次要结局
- Intervention costs(Through study completion (approximately 1 year post study start))
- Changes in health-related quality of life(Baseline, 1 month post intervention and 3 months post intervention)
- Changes in awareness on sources of meaning in everyday life.(Baseline, 1 month post intervention and 3 months post intervention)
- Changes in engagement in sources of meaning in everyday life(Baseline, 1 month post intervention and 3 months post intervention)
- Changes in mutual understanding (dyadic intervention arm)(Baseline, 1 month post intervention and 3 months post intervention)
- Changes in relationship quality (dyadic intervention arm)(Baseline, 1 month post intervention and 3 months post intervention)
- Intervention costs(Through study completion (approximately 1 year post study start))
- Reasons for dropout(At time of dropout (Up to 4 months post intervention))
- Engagement in intervention(1 month post intervention)