Thoracic SurgeryHeartFamNCT05045196
Health-promoting Family Conversations and Open Heart Surgery
A study testing Health promoting conversations in people with Thoracic Surgery, run by Örebro University, Sweden at 3 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Thoracic Surgery
- What is being tested?
- Health promoting conversations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 3 sitesSweden
- Study dates
- 16 Sep 2022to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Sweden3 sites
Department of Thoracic and Vascular Surgery Linköping university hospital
Linköping, Östergötland County, 581 85
Department of Cardiovascular and Thoracic Surgery, Örebro University Hospital
Örebro, Närke, 701 85
Thoracic Surgery and Anesthesia, Uppsala university hospital
Uppsala, Uppland, S-751 85
About this study
Official title: 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.
Read more
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
- Being tested
- Health promoting conversations
- Keywords
- Family Nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health promoting conversationsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Patient and family member of patient undergoing elective open heart surgery- Intervention | Experimental | Family randomized to the intervention group receiving Health-promoting conversation intervention Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family-Sense Of Coherence (F-SOC)
Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items.
Measured: 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
Swedish version of Short Form-36 (SF-36) a questionnaire measuring health-related quality of life. 36 items, 8 dimensions.
Measured: Baseline (before randomization)
RAND-36
Swedish version of Short Form-36 (SF-36) a questionnaire measuring health-related quality of life. 36 items, 8 dimensions.
Measured: 2 weeks after hospital discharge
RAND-36
Swedish version of Short Form-36 (SF-36) a questionnaire measuring health-related quality of life. 36 items, 8 dimensions.
Measured: 3 month follow up
RAND-36
Swedish version of Short Form-36 (SF-36) a questionnaire measuring health-related quality of life. 36 items, 8 dimensions.
Measured: 12 month follow up
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.
Measured: Family members only: 2 weeks after hospital discharge
Cost-Effectiveness of Heath promoting conversations
A questionnaire measuring care utilization and absence from work, 12 items.
Measured: Baseline (before randomization)
Cost-Effectiveness of Heath promoting conversations
A questionnaire measuring care utilization and absence from work, 12 items.
Measured: 2 weeks after hospital discharge
Cost-Effectiveness of Heath promoting conversations
A questionnaire measuring care utilization and absence from work, 12 items.
Measured: 3 month follow up
Cost-Effectiveness of Heath promoting conversations
A questionnaire measuring care utilization and absence from work, 12 items.
Measured: 6 month follow up
Cost-Effectiveness of Heath promoting conversations
A questionnaire measuring care utilization and absence from work, 12 items.
Measured: 12 month follow up
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.
Measured: Baseline
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.
Measured: 2 weeks after hospital discharge
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.
Measured: 3 month follow up
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.
Measured: 12 month follow up
Family-Sense Of Coherence (F-SOC)
Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items.
Measured: Baseline (before randomization)
Family-Sense Of Coherence (F-SOC)
Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items.
Measured: 2 weeks after hospital discharge
Family-Sense Of Coherence (F-SOC)
Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items.
Measured: 12 month follow up
Family Hardiness Index (FHI)
Measurement of the persons perceived hardiness within the family, consisting of 20 items on a 4-point Likert scale.
Measured: Baseline
Family Hardiness Index (FHI)
Measurement of the persons perceived hardiness within the family, consisting of 20 items on a 4-point Likert scale.
Measured: 2 weeks after hospital discharge
Family Hardiness Index (FHI)
Measurement of the persons perceived hardiness within the family, consisting of 20 items on a 4-point Likert scale.
Measured: 3 month follow up
Family Hardiness Index (FHI)
Measurement of the persons perceived hardiness within the family, consisting of 20 items on a 4-point Likert scale.
Measured: 12 month follow up
General Functioning Scale (GFS)
Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale.
Measured: Baseline
General Functioning Scale (GFS)
Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale.
Measured: 2 weeks after hospital discharge
General Functioning Scale (GFS)
Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale.
Measured: 3 month follow up
General Functioning Scale (GFS)
Measurement of the persons perceived family functioning, 12 items on a 4-point Likert scale.
Measured: 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start16 Sep 2022
- Primary completion2 Jun 2024
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth Ericsson, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045196
- Sponsor's protocol ID
- 4.2-05418/2020
- Acronym
- HeartFam
- Status last verified
- Mar 2025
- First submitted
- 13 Nov 2020
- Last updated
- 25 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Drakenberg A, Smith DR, Sundqvist AS, Swenne CL, Ericsson E. Family Health Conversations-A Short-Term Supportive Intervention to Improve Family Well-Being, Functioning, and Involvement in Care After Open-Heart Surgery: A Multicenter, Randomized, Parallel-Group Superiority Trial. J Fam Nurs. 2026 Aug;32(3):159-176. doi: 10.1177/10748407261440159. Epub 2026 Apr 22.
PubMed 42359901
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-promoting Family Conversations and Open Heart Surgery -An Intervention Model for Families: The HeartFam Intervention
- ClinicalTrials.gov ID
- NCT05045196
- Acronym / sponsor ID
- HeartFam / 4.2-05418/2020
- Conditions
- Thoracic Surgery
- Keywords
- Family Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 2 Jun 2024 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient and family member of patient undergoing elective open heart surgery- Intervention | Experimental | Behavioral: Health promoting conversationsFamily randomized to the intervention group receiving Health-promoting conversation intervention |
| 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 |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health promoting conversationsThe 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 | Behavioural | Patient and family member of patient undergoing elective open heart surgery- Intervention |
Primary outcome
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.
25 secondary outcomes
RAND-36
Time frame: Baseline (before randomization)
RAND-36
Time frame: 2 weeks after hospital discharge
RAND-36
Time frame: 3 month follow up
RAND-36
Time frame: 12 month follow up
Family Involvement in Care Questionnaire (FICQ)
Time frame: Family members only: 2 weeks after hospital discharge
Cost-Effectiveness of Heath promoting conversations
Time frame: Baseline (before randomization)
Cost-Effectiveness of Heath promoting conversations
Time frame: 2 weeks after hospital discharge
Cost-Effectiveness of Heath promoting conversations
Time frame: 3 month follow up
Cost-Effectiveness of Heath promoting conversations
Time frame: 6 month follow up
Cost-Effectiveness of Heath promoting conversations
Time frame: 12 month follow up
Postoperative Recovery Profile (PRP)
Time frame: Baseline
Postoperative Recovery Profile (PRP)
Time frame: 2 weeks after hospital discharge
Postoperative Recovery Profile (PRP)
Time frame: 3 month follow up
Postoperative Recovery Profile (PRP)
Time frame: 12 month follow up
Family-Sense Of Coherence (F-SOC)
Time frame: Baseline (before randomization)
Family-Sense Of Coherence (F-SOC)
Time frame: 2 weeks after hospital discharge
Family-Sense Of Coherence (F-SOC)
Time frame: 12 month follow up
Family Hardiness Index (FHI)
Time frame: Baseline
Family Hardiness Index (FHI)
Time frame: 2 weeks after hospital discharge
Family Hardiness Index (FHI)
Time frame: 3 month follow up
Family Hardiness Index (FHI)
Time frame: 12 month follow up
General Functioning Scale (GFS)
Time frame: Baseline
General Functioning Scale (GFS)
Time frame: 2 weeks after hospital discharge
General Functioning Scale (GFS)
Time frame: 3 month follow up
General Functioning Scale (GFS)
Time frame: 12 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Derived from this study: PubMed 42359901Drakenberg A, Smith DR, Sundqvist AS, Swenne CL, Ericsson E. Family Health Conversations-A Short-Term Supportive Intervention to Improve Family Well-Being, Functioning, and Involvement in Care After Open-Heart Surgery: A Multicenter, Randomized, Parallel-Group Superiority Trial. J Fam Nurs. 2026 Aug;32(3):159-176. doi: 10.1177/10748407261440159. Epub 2026 Apr 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Ericsson principal investigator
Örebro University, Sweden
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health promoting conversations in people with Thoracic Surgery, run by Örebro University, Sweden at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05045196, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.