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NCT05045196: HeartFam
Health-promoting Family Conversations and Open Heart Surgery
NA trial testing Health promoting conversations in Thoracic Surgery in 267 participants. Completed in 15 March 2025.
2 June 2024
Quick facts
| Lead sponsor | Örebro University, Sweden |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 267 |
| Start date | 16 September 2022 |
| Primary completion | 2 June 2024 |
| Estimated completion | 15 March 2025 |
| Sites | 3 locations across Sweden |
Drugs / interventions tested
- Health promoting conversations
Conditions studied
- Thoracic Surgery — all drugs for Thoracic Surgery →
Sponsor
Örebro University, Sweden
Who can join
15 and older, any sex, with Thoracic Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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)
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05045196
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Örebro University, Sweden trials
Trials by the same sponsor.
- NCT07521709 — Evaluation of an Online ACT and Compassion-based Intervention for Disorders of Gut-Brain Interaction · NA · not yet recruiting
- NCT07350239 — Clinical, Microbial and Tissue-based Characterization of Patients Treated for Severe Temporomandibular Joint Pathology · not yet recruiting
- NCT07527793 — Monitoring Changes in Blood Circulating Metabolites Using Minimally Invasive Techniques · NA · recruiting
- NCT07175402 — Feasibility and Acceptability of an Online ACT Intervention for Disorders of Gut-Brain Interaction - Beta Trial · NA · completed
- NCT06887751 — Feasibility and Acceptability of an Online ACT Intervention for Disorders of Gut-Brain Interaction · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05045196 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Örebro University, Sweden
- Last refreshed: 25 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05045196.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing