Health-promoting Family Conversations and Open Heart Surgery
- Conditions
- Thoracic Surgery
- Interventions
- Behavioral: Health promoting conversations
- Registration Number
- NCT05045196
- Lead Sponsor
- Örebro University, Sweden
- Brief Summary
Elective open-heart surgery involves physical and psychological strain for the person undergoing surgery. Family plays a significant part in care before and after surgery, and the family has care needs of their own. Health services need to address the family-caregiver burden as an essential aspect of care. Different methods aiming at stress reduction and involvement of patients and family members in care exist. The evidence is conflicting concerning which way is the most effective. Health-promoting conversations are an intervention model promoting family well-being and alleviation of illness and illness-related suffering for the whole family.
Families´ in the intervention group in this trial will, before and after one family member's elective open-heart surgery, participate in Health-promoting conversations. Health-promoting conversation is an intervention model based on the Family Systems Nursing theory. The person undergoing surgery decides which family members should be asked to participate in 1-3 conversations whit a family nurse. Effects on postoperative recovery, health-related quality of life, stress, and patient and family involvement in care will be evaluated with patient- and family-reported outcome measures.
The aim is to evaluate Health-promoting conversation's effect on family wellbeing, functioning, and involvement in care. The cost-effectiveness of the intervention will also be evaluated.
The study will follow the ethical guidelines of the Declaration of Helsinki. The Swedish National Committee on Health Research Ethics reviewed and accepted the study in march 2020 (nr 2019-06315)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 267
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patient and family member of patient undergoing elective open heart surgery- Intervention Health promoting conversations Family randomized to the intervention group receiving Health-promoting conversation intervention
- Primary Outcome Measures
Name Time Method Family-Sense Of Coherence (F-SOC) A statistically significant change in F-SOC from baseline at three months after hospital discharge between the trial patient groups. Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items.
- Secondary Outcome Measures
Name Time Method RAND-36 12 month follow up Swedish version of Short Form-36 (SF-36) a questionnaire measuring health-related quality of life. 36 items, 8 dimensions.
Cost-Effectiveness of Heath promoting conversations 12 month follow up A questionnaire measuring care utilization and absence from work, 12 items.
Family Involvement in Care Questionnaire (FICQ) Family members only: 2 weeks after hospital discharge Person-reported outcome measure, questionnaire measuring family members perceived Instrument measuring family members experiences of involvement in care of the family member who is a patient. 16 items on a 4-point Likert-scale and 2 open ended questions.
Postoperative Recovery Profile (PRP) 12 month follow up Person-reported outcome measure, questionnaire measuring self-reported postoperative recovery. 19 items, 5 dimensions and a cardiac surgery specific module consisting of 9 items.
Family-Sense Of Coherence (F-SOC) 12 month follow up Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items.
General Functioning Scale (GFS) 12 month follow up Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale.
Family Hardiness Index (FHI) 12 month follow up Measurement of the persons perceived hardiness within the family, consisting of 20 items on a 4-point Likert scale.
Trial Locations
- Locations (3)
Department of Cardiovascular and Thoracic Surgery, Örebro University Hospital
🇸🇪Örebro, Närke, Sweden
Thoracic Surgery and Anesthesia, Uppsala university hospital
🇸🇪Uppsala, Uppland, Sweden
Department of Thoracic and Vascular Surgery Linköping university hospital
🇸🇪Linköping, Östergötland, Sweden