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

NCT05503810 | Terminated DMC

• 1 other identifier: HeartBuddyPilot
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Feasibility

Keywords

Loneliness; Social support; cardiac

Outcome Measures

Primary Outcomes (2)

• Feasibility, Acceptability

  Percentage of eligible patients who agree to participate in the trial

  Measured at baseline

• Feasibility, Adherence

  Percentage of patients in contact with the informal caregiver at least once a week face to face, by phone or virtually.

  6 months follow-up after in-hospital cardiac treatment

Secondary Outcomes (3)

• Measure of social network members as informal caregivers

  Measured at baseline

• Measure of informal caregivers

  3 months follow-up after in-hospital cardiac treatment

• Resource consumption

  6 months follow-up after in-hospital cardiac treatment

Other Outcomes (5)

• Loneliness

  Baseline, one, three, six and twelve months

• Self-care

  Baseline, one, three, six and twelve months

• Health-related quality of life

  Baseline, one, three, six and twelve months

Study Arms (2)

Intervention

EXPERIMENTAL

Six month social support intervention following in hospital cardiac treatment

Behavioral: Social support

Control

NO INTERVENTION

Regular follow-up

Interventions

Social support BEHAVIORAL

Contact ones a week with Informal caregiver or peer support

Also known as: Loneliness reduction

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients treated for Ischemic heart disease (CABG or PCI), valve disease (TAVR, SAVR), and arrhythmia (ICD, pacemaker implantation or ablation) treated at Rigshospitalet and classified as high risk lonely according to the High Risk Loneliness (HiRL) tool

You may not qualify if:

• Patients who are unable to provide written consent, therefore, patients with severe cognitive or physical dysfunction will not be approached

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet, Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

Related Publications (2)

• 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.

  PMID: 38910234 DERIVED

• 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.

  PMID: 36747245 DERIVED

Study Officials

• Selina K Berg, Professor

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Mitti Blakø, PhD

  Rigshospitalet, Denmark

  STUDY DIRECTOR

• Anne V Christensen, PhD

  Rigshospitalet, Denmark

  STUDY CHAIR

• Pernille Palm, PhD

  Rigshospitalet, Denmark

  STUDY CHAIR

• Ida E Hojskov, PhD

  Rigshospitalet, Denmark

  STUDY CHAIR

• Camilla Bernild, PhD

  Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized clinical trial design with 1:1 randomization

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 17, 2022
• Study Start: October 5, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Locations

DK (1)