Feasibility
Conditions
Keywords
Loneliness, Social support, cardiac
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.
Interventions
BEHAVIORALSocial support
Contact ones a week with Informal caregiver or peer support
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomized clinical trial design with 1:1 randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility, Acceptability | Measured at baseline | Percentage of eligible patients who agree to participate in the trial |
| Feasibility, Adherence | 6 months follow-up after in-hospital cardiac treatment | Percentage of patients in contact with the informal caregiver at least once a week face to face, by phone or virtually. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure of social network members as informal caregivers | Measured at baseline | Percentage of potential caregivers who accepts to be an informal caregiver |
| Measure of informal caregivers | 3 months follow-up after in-hospital cardiac treatment | Percentage of informal caregivers participating in all three intervention consultations with the trial staff |
| Resource consumption | 6 months follow-up after in-hospital cardiac treatment | Time resources used to complete the three nurse consultations |
Other
| Measure | Time frame | Description |
|---|---|---|
| Self-care | Baseline, one, three, six and twelve months | Self Care Self-Efficacy scale. 10 item scale answered on a Likert scale 1 to 5 with a lower score indicating worse outcome |
| Health-related quality of life | Baseline, one, three, six and twelve months | HeartQoL. 10 item scale answered on a Likert scale 0-5, with a higher score indicating worse outcome |
| Loneliness | Baseline, one, three, six and twelve months | High Risk Loneliness tool. 2 item. Screeningscore 0 to 2, with a higher score indicating worse outcome |
| Anxiety and Depression | Baseline, one, three, six and twelve months | 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 |
| Health behaviors | Baseline, one, three, six and twelve months | Smoking, alcohol consumption, weight, physical activity, participation in cardiac rehabilitation |
Countries
Denmark
Outcome results
None listed