- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07347639
SOCAV: a Nurse-led Support Programme for Self-direction in People With Dementia (SOCAV-program)
SOCAV: a Nurse-led Support Programme for Self-direction in People With Dementia in Dutch Home Care, Involving Informal Caregivers - a Feasibility Study With Process Evaluation
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Brabant
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Etten-Leur, North Brabant, Netherlands, 4876 CV
- Avoord
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- People with dementia were eligible if they had mild to moderate dementia (diagnosed by a general practitioner or geriatrician), lived at home, and received care from a home-care team.
- Informal caregivers were eligible if they provided care at least twice per week, either as a co-residing primary caregiver or as a regularly visiting secondary caregiver.
- Nurses were eligible if they worked in home care, supported people with dementia, and were employed by the regional care organization.
Exclusion Criteria:
- People with dementia were excluded if they had a Geriatric Depression Scale (GDS) score >6;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: SOCAV-Home Care intervention arm
Single-arm study: all participants received SOCAV-Home Care, where home-care nurses were trained and coached to support autonomy in daily decisions, and the person with dementia and caregiver had several home sessions to set goals and agree on practical strategies to maintain choice and independence.
|
SOCAV-Home Care is distinct because it targets "self-direction" in everyday home-care situations by combining (1) structured nurse training in person-centered communication (based on Community Occupational Therapy in Dementia principles), (2) longitudinal Kalorama reflective coaching with reflective diaries to change routine nursing behavior over months, and (3) repeated triadic home sessions (person with dementia + informal caregiver + nurse, sometimes with a peer coach) focused on mapping preferences, setting shared goals, and testing practical autonomy-supporting strategies in the home context.
It is implemented by trained peer coaches within home-care teams rather than as a stand-alone therapy delivered only to patients.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Canadian Occupational Performance Measure
Time Frame: The COPM was administered at baseline and 5 months in the development phase, and in the feasibility phase at baseline, 4 months (midpoint), and 9 months (endpoint).
|
The Canadian Occupational Performance Measure (COPM) (Dutch version) is a tool to assess change in performance of meaningful daily activities and satisfaction with that performance, each rated on a 1-10 scale (1 = not able/not satisfied at all; 10 = fully able/fully satisfied), based on input from the person with dementia, the informal caregiver, and the home-care nurse. Main Manuscript |
The COPM was administered at baseline and 5 months in the development phase, and in the feasibility phase at baseline, 4 months (midpoint), and 9 months (endpoint).
|
|
Canadian Occupational Performance Measure
Time Frame: The COPM was administered at baseline and 5 months in the development phase, and in the feasibility phase at baseline, 4 months (midpoint), and 9 months (endpoint).
|
The Canadian Occupational Performance Measure (COPM) (Dutch version) is a tool to assess change in performance of meaningful daily activities and satisfaction with that performance, each rated on a 1-10 scale (1 = not able/not satisfied at all; 10 = fully able/fully satisfied), based on input from the person with dementia, the informal caregiver, and the home-care nurse.
|
The COPM was administered at baseline and 5 months in the development phase, and in the feasibility phase at baseline, 4 months (midpoint), and 9 months (endpoint).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Dementia Quality of Life (DQoL)
Time Frame: The DQoL was collected as a primary outcome at baseline, 4 months (midpoint), and 9 months (endpoint) in the feasibility phase (and at baseline and 5 months in the development phase).
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The Dementia Quality of Life (DQoL) is a 29-item, dementia-specific quality-of-life measure that is administered as an interview with the person living with dementia and is intended for people with mild to moderate dementia.
It captures the person's own view of their quality of life across key concepts including self-esteem, positive affect/humor, absence of negative affect, feelings of belonging, and sense of aesthetics.
|
The DQoL was collected as a primary outcome at baseline, 4 months (midpoint), and 9 months (endpoint) in the feasibility phase (and at baseline and 5 months in the development phase).
|
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Centre for Epidemiologic Studies Depression Scale (CES-D),
Time Frame: In the feasibility phase, the CES-D was assessed at baseline, 4 months, and 9 months (and at baseline and 5 months in the development phase).
|
The Center for Epidemiologic Studies Depression Scale (CES-D) is a brief questionnaire used to assess depressive symptoms (more symptoms = higher score).
In this study it was used with informal caregivers.
|
In the feasibility phase, the CES-D was assessed at baseline, 4 months, and 9 months (and at baseline and 5 months in the development phase).
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reflective coaching diaries
Time Frame: Nurses completed these continuously throughout the reflective coaching period, starting after the training and continuing until the end of the program, i.e., over approximately 6-9 months (from baseline through the feasibility endpoint).
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Reflective coaching diaries (nurses): qualitative assessment of feasibility/implementation and changes in attitudes/behaviors, analyzed with constant comparison.
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Nurses completed these continuously throughout the reflective coaching period, starting after the training and continuing until the end of the program, i.e., over approximately 6-9 months (from baseline through the feasibility endpoint).
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Collaborators and Investigators
Publications and helpful links
General Publications
- Corporaal, Sharissa & Huijbregts, Ralf & Graff, Maud. (2019). SOCAV: persoonsgerichte zorg bij dementie. Bijblijven. 35. 40-45. 10.1007/s12414-019-0020-z. https://www.researchgate.net/publication/331740573_SOCAV_persoonsgerichte_zorg_bij_dementie
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEC A-N 2019-5689
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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