NCT05503810

Social Support Intervention Targeting Patients Treated for Cardiac Disease Who Experience Loneliness

Terminated NA Last updated 24 November 2023

What this trial tests

NA trial testing Social support in Feasibility in 4 participants. Terminated before completion.

Timeline

5 October 2022

Primary endpoint
1 July 2023

1 July 2023

Quick facts

Lead sponsor	Rigshospitalet, Denmark
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	4
Start date	5 October 2022
Primary completion	1 July 2023
Estimated completion	1 July 2023
Sites	1 location across Denmark

Drugs / interventions tested

• Social support

Conditions studied

• Feasibility — all drugs for Feasibility →

Sponsor

Rigshospitalet, Denmark

Who can join

18 and older, any sex, with Feasibility. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction: In patients treated for cardiac disease, loneliness is known to contribute negatively to health behavior, health outcome and increase risk of cardiac and all-cause mortality. Even so, in health care research, social support interventional studies targeting patients who experience loneliness is lacking.

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Blakø M, Christensen AV, Højskov IE, Palm P, et al · · 2023 · cited 3× · PMID 36747245 · DOI 10.1186/s40814-023-01255-9
2. The rise and fall of a social support intervention feasibility trial targeting loneliness in patients with cardiac disease - lessons learned and future perspectives.
   Blakoe M, Olesen CS, Christensen AV, Palm P, et al · · 2024 · cited 1× · PMID 38910234 · DOI 10.1186/s12912-024-02113-6
3. 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.
   Blakø M, Christensen AV, Højskov IE, Palm P, et al · · 2022 · DOI 10.21203/rs.3.rs-1814664/v1