Health-promoting Family Conversations and Open Heart Surgery (HeartFam)

March 20, 2025 updated by: Örebro University, Sweden

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

267

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Närke
      • Örebro, Närke, Sweden, 701 85
        • Department of Cardiovascular and Thoracic Surgery, Örebro University Hospital
    • Uppland
      • Uppsala, Uppland, Sweden, S-751 85
        • Thoracic Surgery and Anesthesia, Uppsala university hospital
    • Östergötland
      • Linköping, Östergötland, Sweden, 581 85
        • Department of Thoracic and Vascular Surgery Linköping university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

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

Exclusion Criteria patient and family member:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient and family member of patient undergoing elective open heart surgery- Intervention
Family randomized to the intervention group receiving Health-promoting conversation intervention
Behavioral: Health promoting conversations
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
No Intervention: Patient and family member of patient undergoing elective open heart surgery- Control
Family of a patient undergoing elective open-heart surgery randomized to the intervention group receiving standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
A statistically significant change in F-SOC from baseline at three months after hospital discharge between the trial patient groups.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RAND-36
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.
Baseline (before randomization)
RAND-36
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.
2 weeks after hospital discharge
RAND-36
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.
3 month follow up
RAND-36
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.
12 month follow up
Cost-Effectiveness of Heath promoting conversations
Time Frame: Baseline (before randomization)
A questionnaire measuring care utilization and absence from work, 12 items.
Baseline (before randomization)
Cost-Effectiveness of Heath promoting conversations
Time Frame: 2 weeks after hospital discharge
A questionnaire measuring care utilization and absence from work, 12 items.
2 weeks after hospital discharge
Cost-Effectiveness of Heath promoting conversations
Time Frame: 3 month follow up
A questionnaire measuring care utilization and absence from work, 12 items.
3 month follow up
Cost-Effectiveness of Heath promoting conversations
Time Frame: 6 month follow up
A questionnaire measuring care utilization and absence from work, 12 items.
6 month follow up
Cost-Effectiveness of Heath promoting conversations
Time Frame: 12 month follow up
A questionnaire measuring care utilization and absence from work, 12 items.
12 month follow up
Postoperative Recovery Profile (PRP)
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.
Baseline
Postoperative Recovery Profile (PRP)
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.
2 weeks after hospital discharge
Postoperative Recovery Profile (PRP)
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.
3 month follow up
Postoperative Recovery Profile (PRP)
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.
12 month follow up
Family-Sense Of Coherence (F-SOC)
Time Frame: Baseline (before randomization)
Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items.
Baseline (before randomization)
Family-Sense Of Coherence (F-SOC)
Time Frame: 2 weeks after hospital discharge
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)
Time Frame: 12 month follow up
Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items.
12 month follow up
Family Hardiness Index (FHI)
Time Frame: Baseline
Measurement of the persons perceived hardiness within the family, consisting of 20 items on a 4-point Likert scale.
Baseline
Family Hardiness Index (FHI)
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.
2 weeks after hospital discharge
Family Hardiness Index (FHI)
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.
3 month follow up
Family Hardiness Index (FHI)
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.
12 month follow up
General Functioning Scale (GFS)
Time Frame: Baseline
Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale.
Baseline
General Functioning Scale (GFS)
Time Frame: 2 weeks after hospital discharge
Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale.
2 weeks after hospital discharge
General Functioning Scale (GFS)
Time Frame: 3 month follow up
Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale.
3 month follow up
General Functioning Scale (GFS)
Time Frame: 12 month follow up
Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale.
12 month follow up
Family Involvement in Care Questionnaire (FICQ)
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.
Family members only: 2 weeks after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Örebro University, Sweden

Investigators

  • Principal Investigator: Elisabeth Ericsson, Örebro University, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2022

Primary Completion (Actual)

June 2, 2024

Study Completion (Actual)

March 15, 2025

Study Registration Dates

First Submitted

November 13, 2020

First Submitted That Met QC Criteria

September 13, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 20, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 4.2-05418/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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