Social Support Intervention Targeting Patients Treated for Cardiac Disease Who Experience Loneliness
NCT ID: NCT05503810
Last Updated: 2023-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
4 participants
INTERVENTIONAL
2022-10-05
2023-07-01
Brief Summary
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Aim: To determine the feasibility of an individually structured social support intervention targeting patients treated for cardiac disease who experience loneliness.
Design: A feasibility study based on randomized clinical trial design with 1:1 randomization to a 6-month social support program, plus usual care (intervention) versus usual care, (i.e., regular guidelines-based follow-up). Intervention: Patients classified as high risk lonely according to the High Risk Loneliness tool will be provided with an informal caregiver in the six months rehabilitation phase following cardiac disease treatment. The informal caregiver will be designated by the patient from the existing social network or a peer, depending on patients' preferences. The core content of the intervention is through nurse consultations at baseline, one, three and six months, to enhance and reinforce the informal caregiver's competences to be a social support resource. The theoretical framework of the nurse consolations will be based on Middle-range theory of self-care.
Outcome: Feasibility will be evaluated in terms of acceptability and adherence according to predefined feasibility criteria. The preliminary effect of the intervention on patient-reported outcomes, health behaviors and health outcomes will be evaluated in the intervention and the control group at baseline, one, three, six and twelve months.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention
Six month social support intervention following in hospital cardiac treatment
Social support
Contact ones a week with Informal caregiver or peer support
Control
Regular follow-up
No interventions assigned to this group
Interventions
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Social support
Contact ones a week with Informal caregiver or peer support
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Selina Kikkenborg Berg
Professor
Principal Investigators
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Selina K Berg, Professor
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Mitti Blakø, PhD
Role: STUDY_DIRECTOR
Rigshospitalet, Denmark
Anne V Christensen, PhD
Role: STUDY_CHAIR
Rigshospitalet, Denmark
Pernille Palm, PhD
Role: STUDY_CHAIR
Rigshospitalet, Denmark
Ida E Hojskov, PhD
Role: STUDY_CHAIR
Rigshospitalet, Denmark
Camilla Bernild, PhD
Role: STUDY_CHAIR
Rigshospitalet, Denmark
Locations
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Rigshospitalet, Copenhagen University Hospital
Copenhagen, , Denmark
Countries
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References
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Blakoe M, Olesen CS, Christensen AV, Palm P, Hoejskov IE, Berg SK. The rise and fall of a social support intervention feasibility trial targeting loneliness in patients with cardiac disease - lessons learned and future perspectives. BMC Nurs. 2024 Jun 24;23(1):423. doi: 10.1186/s12912-024-02113-6.
Blako M, Christensen AV, Hojskov IE, Palm P, Berg SK. Protocol for a feasibility randomized trial of a social support intervention plus usual care versus usual care, targeting patients treated for cardiac disease who experience loneliness. Pilot Feasibility Stud. 2023 Feb 6;9(1):22. doi: 10.1186/s40814-023-01255-9.
Other Identifiers
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HeartBuddyPilot
Identifier Type: -
Identifier Source: org_study_id