NCT06229431

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Jan 2024Dec 2026

Study Start

First participant enrolled

January 1, 2024

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

1.9 years

First QC Date

January 19, 2024

Last Update Submit

February 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Preparedness for Caregiving Scale (PCS)

    The scale will be used to measure changes in caregiver's self-reported predparedness for caregiving. The scale consists of eight items answered on a five-point Likert-type response scale ranging from 'Not at all prepared' (0) to 'Very well prepared' (4). The responses are summed into a total score with a possible range between 0 and 32.

    Data will be collected at baseline (before the CSNAT-I) and follow-up, 8 and 16 weeks after completed CSNAT-I.

Secondary Outcomes (3)

  • The Quality of Life in Life-Threatening Illness Family caregiver version (QOLLTI-F)

    Data will be collected at baseline (before the CSNAT-I) and follow-up, 8 and 16 weeks after completed CSNAT-I.

  • General health subscale from RAND-36

    Data will be collected at baseline (before the CSNAT-I) and follow-up, 8 and 16 weeks after completed CSNAT-I.

  • The Carer Support Needs Assessment Tool (CSNAT)

    Data will be collected at baseline (before the CSNAT-I) and follow-up, 8 and 16 weeks after completed CSNAT-I.

Study Arms (2)

CSNAT intervention

EXPERIMENTAL

District nurses will be trained to use the CSNAT-I on family caregivers to persons with multimorbidity at home.

Other: The Carer Support Needs Assessment Tool Intervention (CSNAT-I)

Control

NO INTERVENTION

Standard support and care.

Interventions

The CSNAT tool The tool includes 16 questions about the need for more support. The five-stage person-centered approach In the present study, the CSNAT-I consist of at least two meetings between the older spousal caregiver and the district nurse,1-4 weeks apart, following 5 stages: 1. Introduction of the CSNAT tool as a conversation starter. 2. Time for the spousal caregiver to consider the questions in which more support is needed. 3. An assessment conversation takes place. 4. A shared action plan is formed based on the assessment conversation. 5. Continuous shared review of the action plan.

CSNAT intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marie Cederschiöld University

Stockholm, Sweden

Location

Study Officials

  • Anette Alvariza, PhD

    Marie Cedershiöld University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This intervention study has a cluster-randomised design developed in accordance with the CONSORT statement
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project coordinator

Study Record Dates

First Submitted

January 19, 2024

First Posted

January 29, 2024

Study Start

January 1, 2024

Primary Completion

November 30, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations