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Study not feasible. Acceptance rate was too low.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Six month social support intervention following in hospital cardiac treatment |
|
| Control | No Intervention | Regular follow-up |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social support | Behavioral | Contact ones a week with Informal caregiver or peer support |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Selina K Berg, Professor | Rigshospitalet, Denmark | Principal Investigator |
| Mitti Blakø, PhD | Rigshospitalet, Denmark | Study Director |
| Anne V Christensen, PhD | Rigshospitalet, Denmark | Study Chair |
| Pernille Palm, PhD | Rigshospitalet, Denmark | Study Chair |
| Ida E Hojskov, PhD | Rigshospitalet, Denmark | Study Chair |
| Camilla Bernild, PhD | Rigshospitalet, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet, Copenhagen University Hospital | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38910234 | Derived | Blakoe M, Olesen CS, Christensen AV, Palm P, Hoejskov IE, Berg SK. The rise and fall of a social support intervention feasibility trial targeting loneliness in patients with cardiac disease - lessons learned and future perspectives. BMC Nurs. 2024 Jun 24;23(1):423. doi: 10.1186/s12912-024-02113-6. | |
| 36747245 | Derived |
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Randomized clinical trial design with 1:1 randomization
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| 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 |
| 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 |
| Blako M, Christensen AV, Hojskov IE, Palm P, Berg SK. Protocol for a feasibility randomized trial of a social support intervention plus usual care versus usual care, targeting patients treated for cardiac disease who experience loneliness. Pilot Feasibility Stud. 2023 Feb 6;9(1):22. doi: 10.1186/s40814-023-01255-9. |