Clinical trial NCT06229431: Supporting Older Spousal Caregivers Who Care for a Partner With Multimorbidity at Home
Official title: Supporting Older Spousal Caregivers Who Care for a Partner With Multimorbidity at Home - a Cluster Randomized Person-centred Intervention Trial to Promote Preparedness, Quality of Life and Health
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Family Members
Home Care Services
Support, Family
Lead sponsor: Ersta Sköndal University College
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 180
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This intervention study has a cluster-randomised design developed in accordance with the CONSORT statement
Primary purpose: SUPPORTIVE_CARE

Brief summary: Research problem and specific questions:

This project aims to evaluate the person-centred Carer Support Needs Assessment Tool Intervention (C SNAT-I), in Swedish "Ditt behov av stöd". The project goal is to promote preparedness, quality of life and health for older spousal caregivers (≥65 years) who care for a partner (≥65years) with multimorbidity at home.

Data, method and plan for realisation:

With a cluster randomised controlled design in a primary health care context the C SNAT-I will be tested. The intervention consists of two parts, an evidence-based tool and a personcentred five stage process to proactively identify and address caregivers needs: 1) introduction of the CSNAT tool comprising 16 questions about the need for support, 2) caregiver consideration and reflection on support needs, 3) an assessment conversation between the caregiver and a nurse, 4) a shared action plan is formed and 5) continuous review of support needs and action plan. Primary health care centres will be randomized to intervention or control arm. Multiple research methods for data collection and analyses will be used. In total 180 caregivers will be recruited for one year and data collected at baseline, 8 and 16 weeks later.

Detailed description: Research problem and specific questions: This project aims to evaluate the person-centred Carer Support Needs Assessment Tool Intervention (CSNAT-I), in Swedish "Ditt behov av stöd". The project goal is to promote preparedness, quality of life and health for older spousal caregivers (≥65 years) who care for a partner (≥65 years) with multimorbidity at home.

Data, method and plan for realisation: With a cluster randomised controlled design in a primary health care context the CSNAT-I will be tested. The intervention consists of two parts, an evidence-based tool and a person-centred five stage process to proactively identify and address caregivers needs: 1) introduction of the CSNAT tool comprising 16 questions about the need for support, 2) caregiver consideration and reflection on support needs, 3) an assessment conversation between the caregiver and a nurse, 4) a shared action plan is formed and 5) continuous review of support needs and action plan. Primary health care centres will be randomized to intervention or control arm. Multiple research methods for data collection and analyses will be used. In total 180 caregivers will be recruited for one year and data collected at baseline, 8 and 16 weeks later. The realisation of the project is strengthened by previous research and the current collaboration between researchers at four universities, the Academic Primary Health Care Centre, Stockholm Gerontology Research Center, a care consultant and a caregiver representative.

Social relevance and utilisation: National and international studies have shown the CSNAT-I to be beneficial for both family caregivers and health care professionals in specialised home care. The CSNAT tool and a training toolkit for health care professionals including guidance about how to work with the intervention is available in Swedish. The intervention is successfully tested in specialised palliative home care in Sweden. Given older spousal caregivers need of support, it is vital to evaluate the CSNAT-I in the new context of primary home health care. This is important as primary health care is emphasized as the foundation stone in Swedish health care according to the national guidelines of "Nära vård". The project ties in with the first "Nationella anhörigstrategi" which aims at promoting support for family caregivers. If preparedness, quality of life and health is found to be promoted, the CSNAT-I can be used to support older caregivers proactively and systematically.

Eligibility criteria: Inclusion Criteria:

Older spousal caregivers, who cares for a partner (≥65 years) diagnosed with multimorbidity and admitted to primary home health care, are to be included in the study. Caregivers should be ≥65 years and understand and speak the Swedish language.

Exclusion Criteria:

-

Primary outcomes:
measure: The Preparedness for Caregiving Scale (PCS)
timeFrame: Data will be collected at baseline (before the CSNAT-I) and follow-up, 8 and 16 weeks after completed CSNAT-I.
Secondary outcomes:
measure: The Quality of Life in Life-Threatening Illness Family caregiver version (QOLLTI-F)
timeFrame: Data will be collected at baseline (before the CSNAT-I) and follow-up, 8 and 16 weeks after completed CSNAT-I.
measure: General health subscale from RAND-36
timeFrame: Data will be collected at baseline (before the CSNAT-I) and follow-up, 8 and 16 weeks after completed CSNAT-I.
measure: The Carer Support Needs Assessment Tool (CSNAT)
timeFrame: Data will be collected at baseline (before the CSNAT-I) and follow-up, 8 and 16 weeks after completed CSNAT-I.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Marie Cederschiöld University
Study officials:
affiliation: Marie Cedershiöld University
name: Anette Alvariza, PhD
role: PRINCIPAL_INVESTIGATOR
References: