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

Study Overview
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Brief Summary
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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.

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

Conditions
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Feasibility

Intervention / Treatment
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* Behavioral: Social support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial design with 1:1 randomization
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Loneliness, Social support, cardiac