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

Ö

Örebro University, Sweden

Status

Completed

Conditions

Thoracic Surgery

Treatments

Behavioral: Health promoting conversations

Study type

Interventional

Funder types

Other

Identifiers

NCT05045196
4.2-05418/2020

Details and patient eligibility

About

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)

Enrollment

267 patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

267 participants in 2 patient groups

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

Trial contacts and locations

3

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Central trial contact

Anna Drakenberg; Elisabeth Ericsson

Data sourced from clinicaltrials.gov

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