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

Feasibility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05503810
• Other study ID #: HeartBuddyPilot
• Status: Terminated
• Phase: N/A
• Start date: October 5, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: November 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Feasibility
• Heart Diseases

Intervention

Behavioral:
• Social support
Contact ones a week with Informal caregiver or peer support

Locations

Country	Name	City	State
Denmark	Rigshospitalet, Copenhagen University Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	Health behaviors	Smoking, alcohol consumption, weight, physical activity, participation in cardiac rehabilitation	Baseline, one, three, six and twelve months
Primary	Feasibility, Acceptability	Percentage of eligible patients who agree to participate in the trial	Measured at baseline
Primary	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	Measure of social network members as informal caregivers	Percentage of potential caregivers who accepts to be an informal caregiver	Measured at baseline
Secondary	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
Secondary	Resource consumption	Time resources used to complete the three nurse consultations	6 months follow-up after in-hospital cardiac treatment