NCT Number: NCT05045196
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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Notify Me15 year and older
All sexes
Interventional
Not applicable
Department of Cardiovascular and Thoracic Surgery, Örebro University Hospital, Örebro, Närke, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients:
Family members
Exclusion criteria
patient and family member:
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
Time frame: 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.
Time frame: Baseline (before randomization)
Swedish version of Short Form-36 (SF-36) a questionnaire measuring health-related quality of life. 36 items, 8 dimensions.
Time frame: 2 weeks after hospital discharge
Swedish version of Short Form-36 (SF-36) a questionnaire measuring health-related quality of life. 36 items, 8 dimensions.
Time frame: 3 month follow up
Swedish version of Short Form-36 (SF-36) a questionnaire measuring health-related quality of life. 36 items, 8 dimensions.
Time frame: 12 month follow up
Swedish version of Short Form-36 (SF-36) a questionnaire measuring health-related quality of life. 36 items, 8 dimensions.
Time frame: 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.
Time frame: Baseline (before randomization)
A questionnaire measuring care utilization and absence from work, 12 items.
Time frame: 2 weeks after hospital discharge
A questionnaire measuring care utilization and absence from work, 12 items.
Time frame: 3 month follow up
A questionnaire measuring care utilization and absence from work, 12 items.
Time frame: 6 month follow up
A questionnaire measuring care utilization and absence from work, 12 items.
Time frame: 12 month follow up
A questionnaire measuring care utilization and absence from work, 12 items.
Time frame: Baseline
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.
Time frame: 2 weeks after hospital discharge
Person-reported outcome measure, questionnaire measuring self-reported postoperative recovery. 19 items, 5 dimensions and a cardiac surgery specific module consisting of 9 items.
Time frame: 3 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.
Time frame: 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.
Time frame: Baseline (before randomization)
Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items.
Time frame: 2 weeks after hospital discharge
Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items.
Time frame: 12 month follow up
Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items.
Time frame: Baseline
Measurement of the persons perceived hardiness within the family, consisting of 20 items on a 4-point Likert scale.
Time frame: 2 weeks after hospital discharge
Measurement of the persons perceived hardiness within the family, consisting of 20 items on a 4-point Likert scale.
Time frame: 3 month follow up
Measurement of the persons perceived hardiness within the family, consisting of 20 items on a 4-point Likert scale.
Time frame: 12 month follow up
Measurement of the persons perceived hardiness within the family, consisting of 20 items on a 4-point Likert scale.
Time frame: Baseline
Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale.
Time frame: 2 weeks after hospital discharge
Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale.
Time frame: 3 month follow up
Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale.
Time frame: 12 month follow up
Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale.
Örebro University, Sweden
Other
Health-promoting Family Conversations and Open Heart Surgery -An Intervention Model for Families: The HeartFam Intervention
Acronym: HeartFam
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