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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient and family member of patient undergoing elective open heart surgery- Intervention | Experimental | Family randomized to the intervention group receiving Health-promoting conversation intervention |
|
| Patient and family member of patient undergoing elective open heart surgery- Control | No Intervention | Family of a patient undergoing elective open-heart surgery randomized to the intervention group receiving standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health promoting conversations | Behavioral | The Health-promoting conversations intervention is a conversation model between the patient, family members, and a trained nurse. Patients and families included in the study will, after submitting base-line-data, be randomized to |
| Measure | Description | Time Frame |
|---|---|---|
| Family-Sense Of Coherence (F-SOC) | Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items. | A statistically significant change in F-SOC from baseline at three months after hospital discharge between the trial patient groups. |
| Measure | Description | Time Frame |
|---|---|---|
| RAND-36 | Swedish version of Short Form-36 (SF-36) a questionnaire measuring health-related quality of life. 36 items, 8 dimensions. | Baseline (before randomization) |
| RAND-36 | Swedish version of Short Form-36 (SF-36) a questionnaire measuring health-related quality of life. 36 items, 8 dimensions. |
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Inclusion Criteria
Patients:
Family members
Exclusion Criteria patient and family member:
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Ericsson | Örebro University, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiovascular and Thoracic Surgery, Örebro University Hospital | Örebro | Närke | 701 85 | Sweden | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42359901 | Derived | Drakenberg A, Smith DR, Sundqvist AS, Swenne CL, Ericsson E. Family Health Conversations-A Short-Term Supportive Intervention to Improve Family Well-Being, Functioning, and Involvement in Care After Open-Heart Surgery: A Multicenter, Randomized, Parallel-Group Superiority Trial. J Fam Nurs. 2026 Aug;32(3):159-176. doi: 10.1177/10748407261440159. Epub 2026 Apr 22. |
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| 2 weeks after hospital discharge |
| RAND-36 | Swedish version of Short Form-36 (SF-36) a questionnaire measuring health-related quality of life. 36 items, 8 dimensions. | 3 month follow up |
| RAND-36 | Swedish version of Short Form-36 (SF-36) a questionnaire measuring health-related quality of life. 36 items, 8 dimensions. | 12 month follow up |
| Family Involvement in Care Questionnaire (FICQ) | 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. | Family members only: 2 weeks after hospital discharge |
| Cost-Effectiveness of Heath promoting conversations | A questionnaire measuring care utilization and absence from work, 12 items. | Baseline (before randomization) |
| Cost-Effectiveness of Heath promoting conversations | A questionnaire measuring care utilization and absence from work, 12 items. | 2 weeks after hospital discharge |
| Cost-Effectiveness of Heath promoting conversations | A questionnaire measuring care utilization and absence from work, 12 items. | 3 month follow up |
| Cost-Effectiveness of Heath promoting conversations | A questionnaire measuring care utilization and absence from work, 12 items. | 6 month follow up |
| Cost-Effectiveness of Heath promoting conversations | A questionnaire measuring care utilization and absence from work, 12 items. | 12 month follow up |
| Postoperative Recovery Profile (PRP) | Person-reported outcome measure, questionnaire measuring self-reported postoperative recovery. 19 items, 5 dimensions and a cardiac surgery specific module consisting of 7 items at baseline. | Baseline |
| Postoperative Recovery Profile (PRP) | Person-reported outcome measure, questionnaire measuring self-reported postoperative recovery. 19 items, 5 dimensions and a cardiac surgery specific module consisting of 9 items. | 2 weeks after hospital discharge |
| Postoperative Recovery Profile (PRP) | Person-reported outcome measure, questionnaire measuring self-reported postoperative recovery. 19 items, 5 dimensions and a cardiac surgery specific module consisting of 9 items. | 3 month follow up |
| Postoperative Recovery Profile (PRP) | Person-reported outcome measure, questionnaire measuring self-reported postoperative recovery. 19 items, 5 dimensions and a cardiac surgery specific module consisting of 9 items. | 12 month follow up |
| Family-Sense Of Coherence (F-SOC) | Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items. | Baseline (before randomization) |
| Family-Sense Of Coherence (F-SOC) | Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items. | 2 weeks after hospital discharge |
| Family-Sense Of Coherence (F-SOC) | Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items. | 12 month follow up |
| Family Hardiness Index (FHI) | Measurement of the persons perceived hardiness within the family, consisting of 20 items on a 4-point Likert scale. | Baseline |
| Family Hardiness Index (FHI) | Measurement of the persons perceived hardiness within the family, consisting of 20 items on a 4-point Likert scale. | 2 weeks after hospital discharge |
| Family Hardiness Index (FHI) | Measurement of the persons perceived hardiness within the family, consisting of 20 items on a 4-point Likert scale. | 3 month follow up |
| Family Hardiness Index (FHI) | Measurement of the persons perceived hardiness within the family, consisting of 20 items on a 4-point Likert scale. | 12 month follow up |
| General Functioning Scale (GFS) | Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale. | Baseline |
| General Functioning Scale (GFS) | Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale. | 2 weeks after hospital discharge |
| General Functioning Scale (GFS) | Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale. | 3 month follow up |
| General Functioning Scale (GFS) | Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale. | 12 month follow up |
| Thoracic Surgery and Anesthesia, Uppsala university hospital |
| Uppsala |
| Uppland |
| S-751 85 |
| Sweden |
| Department of Thoracic and Vascular Surgery Linköping university hospital | Linköping | Östergötland County | 581 85 | Sweden |