Clinical Trials Directory

Trials / Completed

CompletedNCT05045196

Health-promoting Family Conversations and Open Heart Surgery

Health-promoting Family Conversations and Open Heart Surgery -An Intervention Model for Families: The HeartFam Intervention

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
267 (actual)
Sponsor
Örebro University, Sweden · Academic / Other
Sex
All
Age
15 Years
Healthy volunteers
Not accepted

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)

Conditions

Interventions

TypeNameDescription
BEHAVIORALHealth promoting conversationsThe 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

Timeline

Start date
2022-09-16
Primary completion
2024-06-02
Completion
2025-03-15
First posted
2021-09-16
Last updated
2025-03-25

Locations

3 sites across 1 country: Sweden

Source: ClinicalTrials.gov record NCT05045196. Inclusion in this directory is not an endorsement.