Clinical trial NCT05503810: Social Support Intervention Targeting Patients Treated for Cardiac Disease Who Experience Loneliness
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Feasibility
Keywords: Loneliness
Social support
cardiac
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial design with 1:1 randomization
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility, Acceptability
timeFrame: Measured at baseline
measure: Feasibility, Adherence
timeFrame: 6 months follow-up after in-hospital cardiac treatment
Secondary outcomes:
measure: Measure of social network members as informal caregivers
timeFrame: Measured at baseline
measure: Measure of informal caregivers
timeFrame: 3 months follow-up after in-hospital cardiac treatment
measure: Resource consumption
timeFrame: 6 months follow-up after in-hospital cardiac treatment
Other outcomes:
measure: Loneliness
timeFrame: Baseline, one, three, six and twelve months
measure: Self-care
timeFrame: Baseline, one, three, six and twelve months
measure: Health-related quality of life
timeFrame: Baseline, one, three, six and twelve months
measure: Anxiety and Depression
timeFrame: Baseline, one, three, six and twelve months
measure: Health behaviors
timeFrame: Baseline, one, three, six and twelve months
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Copenhagen University Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Selina K Berg, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Mitti Blakø, PhD
role: STUDY_DIRECTOR
affiliation: Rigshospitalet, Denmark
name: Anne V Christensen, PhD
role: STUDY_CHAIR
affiliation: Rigshospitalet, Denmark
name: Pernille Palm, PhD
role: STUDY_CHAIR
affiliation: Rigshospitalet, Denmark
name: Ida E Hojskov, PhD
role: STUDY_CHAIR
affiliation: Rigshospitalet, Denmark
name: Camilla Bernild, PhD
role: STUDY_CHAIR
References: