Health-promoting Family Conversations and Open Heart Surgery

Thoracic Surgery Clinical Trial

— HeartFam  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05045196
• Other study ID #: 4.2-05418/2020
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2022
• Est. completion date: April 2025

Study information

• Verified date: December 2023
• Source: Örebro University, Sweden
• Contact: Anna Drakenberg
• Phone: +46706843963
• Email: anna.drakenberg[@]oru.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 232
• Est. completion date: April 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thoracic Surgery

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

Locations

Country	Name	City	State
Sweden	Department of Thoracic and Vascular Surgery Linköping university hospital	Linköping	Östergötland
Sweden	Department of Cardiovascular and Thoracic Surgery, Örebro University Hospital	Örebro	Närke
Sweden	Thoracic Surgery and Anesthesia, Uppsala university hospital	Uppsala	Uppland

Sponsors (1)

Lead Sponsor	Collaborator
Örebro University, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Family-Sense Of Coherence (F-SOC)	Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items.	A clinically significant change in F-SOC from baseline at three months after hospital discharge between the trial patient groups.
Secondary	RAND-36	Swedish version of Short Form-36 (SF-36) a questionnaire measuring health-related quality of life. 36 items, 8 dimensions.	Baseline (before randomization)
Secondary	RAND-36	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
Secondary	RAND-36	Swedish version of Short Form-36 (SF-36) a questionnaire measuring health-related quality of life. 36 items, 8 dimensions.	3 month follow up
Secondary	RAND-36	Swedish version of Short Form-36 (SF-36) a questionnaire measuring health-related quality of life. 36 items, 8 dimensions.	12 month follow up
Secondary	Family Involvement in Care Questionnaire (FICQ)	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
Secondary	Cost-Effectiveness of Heath promoting conversations	A questionnaire measuring care utilization and absence from work, 12 items.	Baseline (before randomization)
Secondary	Cost-Effectiveness of Heath promoting conversations	A questionnaire measuring care utilization and absence from work, 12 items.	2 weeks after hospital discharge
Secondary	Cost-Effectiveness of Heath promoting conversations	A questionnaire measuring care utilization and absence from work, 12 items.	3 month follow up
Secondary	Cost-Effectiveness of Heath promoting conversations	A questionnaire measuring care utilization and absence from work, 12 items.	6 month follow up
Secondary	Cost-Effectiveness of Heath promoting conversations	A questionnaire measuring care utilization and absence from work, 12 items.	12 month follow up
Secondary	Postoperative Recovery Profile (PRP)	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
Secondary	Postoperative Recovery Profile (PRP)	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
Secondary	Postoperative Recovery Profile (PRP)	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
Secondary	Postoperative Recovery Profile (PRP)	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
Secondary	Family-Sense Of Coherence (F-SOC)	Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items.	Baseline (before randomization)
Secondary	Family-Sense Of Coherence (F-SOC)	Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items.	2 weeks after hospital discharge
Secondary	Family-Sense Of Coherence (F-SOC)	Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items.	12 month follow up
Secondary	Family Hardiness Index (FHI)	Measurement of the persons perceived hardiness within the family, consisting of 20 items on a 4-point Likert scale.	Baseline
Secondary	Family Hardiness Index (FHI)	Measurement of the persons perceived hardiness within the family, consisting of 20 items on a 4-point Likert scale.	2 weeks after hospital discharge
Secondary	Family Hardiness Index (FHI)	Measurement of the persons perceived hardiness within the family, consisting of 20 items on a 4-point Likert scale.	3 month follow up
Secondary	Family Hardiness Index (FHI)	Measurement of the persons perceived hardiness within the family, consisting of 20 items on a 4-point Likert scale.	12 month follow up
Secondary	General Functioning Scale (GFS)	Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale.	Baseline
Secondary	General Functioning Scale (GFS)	Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale.	2 weeks after hospital discharge
Secondary	General Functioning Scale (GFS)	Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale.	3 month follow up
Secondary	General Functioning Scale (GFS)	Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale.	12 month follow up