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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
4
Contact ones a week with Informal caregiver or peer support
Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark
Feasibility, Acceptability
Percentage of eligible patients who agree to participate in the trial
Time frame: 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.
Time frame: 6 months follow-up after in-hospital cardiac treatment
Measure of social network members as informal caregivers
Percentage of potential caregivers who accepts to be an informal caregiver
Time frame: Measured at baseline
Measure of informal caregivers
Percentage of informal caregivers participating in all three intervention consultations with the trial staff
Time frame: 3 months follow-up after in-hospital cardiac treatment
Resource consumption
Time resources used to complete the three nurse consultations
Time frame: 6 months follow-up after in-hospital cardiac treatment
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