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Clinical Trials/NCT05045196
NCT05045196
Completed
Not Applicable

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

Örebro University, Sweden3 sites in 1 country267 target enrollmentSeptember 16, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thoracic Surgery
Sponsor
Örebro University, Sweden
Enrollment
267
Locations
3
Primary Endpoint
Family-Sense Of Coherence (F-SOC)
Status
Completed
Last Updated
last year

Overview

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)

Registry
clinicaltrials.gov
Start Date
September 16, 2022
End Date
March 15, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Örebro University, Sweden
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Family-Sense Of Coherence (F-SOC)

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.

Secondary Outcomes

  • RAND-36(12 month follow up)
  • Cost-Effectiveness of Heath promoting conversations(12 month follow up)
  • Family Involvement in Care Questionnaire (FICQ)(Family members only: 2 weeks after hospital discharge)
  • Postoperative Recovery Profile (PRP)(12 month follow up)
  • Family-Sense Of Coherence (F-SOC)(12 month follow up)
  • General Functioning Scale (GFS)(12 month follow up)
  • Family Hardiness Index (FHI)(12 month follow up)

Study Sites (3)

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