Family MembersNCT06229431
Supporting Older Spousal Caregivers Who Care for a Partner With Multimorbidity at Home
A study testing The Carer Support Needs Assessment Tool Intervention (CSNAT-I) in people with Family Members and Home Care Services, run by Ersta Sköndal University College at 1 site in Sweden.
Trial 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". Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Family Members, Home Care Services, Support, Family
- What is being tested?
- The Carer Support Needs Assessment Tool Intervention (CSNAT-I)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Family Members, Home Care Services, Support, Family
- Being tested
- The Carer Support Needs Assessment Tool Intervention (CSNAT-I)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Carer Support Needs Assessment Tool Intervention (CSNAT-I)Other
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:
- Introduction of the CSNAT tool as a conversation starter.
- Time for the spousal caregiver to consider the questions in which more support is needed.
- An assessment conversation takes place.
- A shared action plan is formed based on the assessment conversation.
- Continuous shared review of the action plan.
| Study group | Role | What they receive |
|---|---|---|
| CSNAT intervention | Experimental | District nurses will be trained to use the CSNAT-I on family caregivers to persons with multimorbidity at home. Receives: Other: The Carer Support Needs Assessment Tool Intervention (CSNAT-I) |
| Control | No intervention | Standard support and care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The scale will be used to measure changes in caregiver's self-reported quality of life. The scale consists of a total of 17 items divided into 7 subscales assessing different domains of quality of life: Environment, Patient condition, Family caregiver's own state, Family caregiver's outlook, Quality of care, Relationships, and Financial worries. It also includes 1 item about overall Quality of life. All items are scored on an 11-point numeric rating scale, ranging between 0-10 with a descriptive anchor at each extreme. Each domain is calculated by adding the responses and dividing the sum by the number of items in each domain. Thus, each domain can range between 0-10, and after reversed items have been rescored, higher scores indicate higher levels of quality of life
Measured: 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
The scale will be used to measure changes in in caregiver's self-reported health. For this study we have choosen to use a single item measuring general health. The item is calculated on a five point scale, ranging from 1-5, where higher values indicate better health.
Measured: 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)
The scale will be used to measure changes in caregiver's self-reported support needs. The instrument consists of 16 domains/questions. The CSNAT has three response categories indicating how much more support caregivers need, ranging from 'no more support' to 'very much more support'. The CSNAT is not developed to be summed into a total score.
Measured: Data will be collected at baseline (before the CSNAT-I) and follow-up, 8 and 16 weeks after completed CSNAT-I.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start1 Jan 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family MembersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This intervention study has a cluster-randomised design developed in accordance with the CONSORT statement
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ersta Sköndal University College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Norinder, Ersta Sköndal University College
- Investigators
- Anette Alvariza, PhD, Principal investigator, Marie Cedershiöld University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229431
- Sponsor's protocol ID
- ErstaSUC3
- Status last verified
- Feb 2024
- First submitted
- 19 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06229431
- Acronym / sponsor ID
- ErstaSUC3
- Conditions
- Family Members, Home Care Services, Support, Family
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Ersta Sköndal University CollegeUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This intervention study has a cluster-randomised design developed in accordance with the CONSORT statement
| Arm | Type | Receives |
|---|---|---|
| CSNAT intervention | Experimental | Other: The Carer Support Needs Assessment Tool Intervention (CSNAT-I)District nurses will be trained to use the CSNAT-I on family caregivers to persons with multimorbidity at home. |
| Control | No intervention | –Standard support and care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Carer Support Needs Assessment Tool Intervention (CSNAT-I)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. | Other | CSNAT intervention |
Primary outcome
The Preparedness for Caregiving Scale (PCS)
Time frame: Data will be collected at baseline (before the CSNAT-I) and follow-up, 8 and 16 weeks after completed CSNAT-I.
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.
3 secondary outcomes
The Quality of Life in Life-Threatening Illness Family caregiver version (QOLLTI-F)
Time frame: 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
Time frame: 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)
Time frame: Data will be collected at baseline (before the CSNAT-I) and follow-up, 8 and 16 weeks after completed CSNAT-I.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anette Alvariza, PhD principal investigator
Marie Cedershiöld University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Carer Support Needs Assessment Tool Intervention (CSNAT-I) in people with Family Members and Home Care Services, run by Ersta Sköndal University College at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Preparedness for Caregiving Scale (PCS) (time frame: Data will be collected at baseline (before the CSNAT-I) and follow-up, 8 and 16 weeks after completed CSNAT-I.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.