Health-promoting Family Conversations and Open Heart Surgery

NCT05045196 | Completed

• 1 other identifier: 4.2-05418/2020
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 3

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)

Conditions

Thoracic Surgery

Keywords

Family Nursing

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (25)

• RAND-36

  Baseline (before randomization)

• RAND-36

  2 weeks after hospital discharge

• RAND-36

  3 month follow up

• RAND-36

  12 month follow up

• Family Involvement in Care Questionnaire (FICQ)

  Family members only: 2 weeks after hospital discharge

Study Arms (2)

Patient and family member of patient undergoing elective open heart surgery- Intervention

EXPERIMENTAL

Family randomized to the intervention group receiving Health-promoting conversation intervention

Behavioral: Health promoting conversations

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

Interventions

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

Patient and family member of patient undergoing elective open heart surgery- Intervention

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients:
• Patients =/\>18 years of age
• undergoing elective, open-heart surgery
• having a minimum of one family member willing to participate in Health-promoting conversations
• Family members
• Family member of a patient undergoing elective, open-heart surgery
• willing to participate in Health-promoting conversations \*=/\> 15 years of age

You may not qualify if:

• Inability to speak or understand Swedish to the extent of giving informed consent
• Cognitive and/or psychiatric disorder to the extent of not being able to give informed consent

Sponsors & Collaborators

• Örebro University, Sweden: lead

Study Sites (3)

Department of Cardiovascular and Thoracic Surgery, Örebro University Hospital

Örebro, Närke, 701 85, Sweden

Location

Thoracic Surgery and Anesthesia, Uppsala university hospital

Uppsala, Uppland, S-751 85, Sweden

Location

Department of Thoracic and Vascular Surgery Linköping university hospital

Linköping, Östergötland County, 581 85, Sweden

Location

Study Officials

• Elisabeth Ericsson

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: September 16, 2021
• Study Start: September 16, 2022
• Primary Completion: June 2, 2024
• Study Completion: March 15, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

SE (3)