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

Feasibility Randomized Trial of a Social Support Intervention Plus Usual Care Versus Usual Care, Targeting Patients Treated for Cardiac Disease Who Experience Loneliness

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.

Study Overview

• Status: Recruiting
• Conditions: Feasibility
• Intervention / Treatment: Behavioral: Social support

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Rigshospitalet, Copenhagen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Six month social support intervention following in hospital cardiac treatment	Behavioral: Social support; Contact ones a week with Informal caregiver or peer support; Other Names: Loneliness reduction
No Intervention: Control; Regular follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of social network members as informal caregivers	Percentage of potential caregivers who accepts to be an informal caregiver	Measured at baseline
Measure of informal caregivers	Percentage of informal caregivers participating in all three intervention consultations with the trial staff	3 months follow-up after in-hospital cardiac treatment
Resource consumption	Time resources used to complete the three nurse consultations	6 months follow-up after in-hospital cardiac treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Loneliness	High Risk Loneliness tool. 2 item. Screeningscore 0 to 2, with a higher score indicating worse outcome	Baseline, one, three, six and twelve months
Self-care	Self Care Self-Efficacy scale. 10 item scale answered on a Likert scale 1 to 5 with a lower score indicating worse outcome	Baseline, one, three, six and twelve months
Health-related quality of life	HeartQoL. 10 item scale answered on a Likert scale 0-5, with a higher score indicating worse outcome	Baseline, one, three, six and twelve months
Anxiety and Depression	Hospital Anxiety and Depression scale (HADS). 14 item scale. The scale offers two scores, HADS-A (anxiety) and HADS-D (depression). Answered in a Likert scale with a higher score indicating worse outcome	Baseline, one, three, six and twelve months
Health behaviors	Smoking, alcohol consumption, weight, physical activity, participation in cardiac rehabilitation	Baseline, one, three, six and twelve months

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: August 10, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Loneliness; cardiac; Social support
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: HeartBuddyPilot

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No