Clinical trial NCT05045196: Health-promoting Family Conversations and Open Heart Surgery
Official title: Health-promoting Family Conversations and Open Heart Surgery -An Intervention Model for Families: The HeartFam Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Surgery
Keywords: Family Nursing
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 267
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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)


Eligibility criteria: 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

Primary outcomes:
measure: Family-Sense Of Coherence (F-SOC)
timeFrame: A statistically significant change in F-SOC from baseline at three months after hospital discharge between the trial patient groups.
Secondary outcomes:
measure: RAND-36
timeFrame: Baseline (before randomization)
measure: RAND-36
timeFrame: 2 weeks after hospital discharge
measure: RAND-36
timeFrame: 3 month follow up
measure: RAND-36
timeFrame: 12 month follow up
measure: Family Involvement in Care Questionnaire (FICQ)
timeFrame: Family members only: 2 weeks after hospital discharge
measure: Cost-Effectiveness of Heath promoting conversations
timeFrame: Baseline (before randomization)
measure: Cost-Effectiveness of Heath promoting conversations
timeFrame: 2 weeks after hospital discharge
measure: Cost-Effectiveness of Heath promoting conversations
timeFrame: 3 month follow up
measure: Cost-Effectiveness of Heath promoting conversations
timeFrame: 6 month follow up
measure: Cost-Effectiveness of Heath promoting conversations
timeFrame: 12 month follow up
measure: Postoperative Recovery Profile (PRP)
timeFrame: Baseline
measure: Postoperative Recovery Profile (PRP)
timeFrame: 2 weeks after hospital discharge
measure: Postoperative Recovery Profile (PRP)
timeFrame: 3 month follow up
measure: Postoperative Recovery Profile (PRP)
timeFrame: 12 month follow up
measure: Family-Sense Of Coherence (F-SOC)
timeFrame: Baseline (before randomization)
measure: Family-Sense Of Coherence (F-SOC)
timeFrame: 2 weeks after hospital discharge
measure: Family-Sense Of Coherence (F-SOC)
timeFrame: 12 month follow up
measure: Family Hardiness Index (FHI)
timeFrame: Baseline
measure: Family Hardiness Index (FHI)
timeFrame: 2 weeks after hospital discharge
measure: Family Hardiness Index (FHI)
timeFrame: 3 month follow up
measure: Family Hardiness Index (FHI)
timeFrame: 12 month follow up
measure: General Functioning Scale (GFS)
timeFrame: Baseline
measure: General Functioning Scale (GFS)
timeFrame: 2 weeks after hospital discharge
measure: General Functioning Scale (GFS)
timeFrame: 3 month follow up
measure: General Functioning Scale (GFS)
timeFrame: 12 month follow up
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Department of Cardiovascular and Thoracic Surgery, Örebro University Hospital
state: Närke
city: Uppsala
country: Sweden
facility: Thoracic Surgery and Anesthesia, Uppsala university hospital
state: Uppland
city: Linköping
country: Sweden
facility: Department of Thoracic and Vascular Surgery Linköping university hospital
state: Östergötland
Study officials:
affiliation: Örebro University, Sweden
name: Elisabeth Ericsson
role: PRINCIPAL_INVESTIGATOR
References: