SOCAV: a Nurse-led Support Programme for Self-direction in People With Dementia (SOCAV-program)

January 8, 2026 updated by: Radboud University Medical Center

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

In this study, we tested whether a support program could help people living at home with dementia keep making their own everyday choices for as long as possible, with help from a family caregiver and a home-care nurse. Nurses received training and coaching to better focus on what the person still wants and can do, and to avoid taking over tasks too quickly. The program also included home conversations with the person with dementia and their caregiver to agree on what matters most and how to support that in daily life. In total, 12 people with dementia, 14 caregivers, and 33 nurses took part. Most participants felt the program was helpful and said it increased attention to personal choice and small day-to-day decisions. However, it also took time and was sometimes hard to schedule, and some people dropped out. The questionnaires did not show clear improvements in things like quality of life, but there were signs that some behavior problems (such as restlessness or difficult situations) became less frequent for some participants.

Study Overview

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Brabant
      • Etten-Leur, North Brabant, Netherlands, 4876 CV
        • Avoord

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • SOCAV program
  • SOCAV home care

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).
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).
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).

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).
Reflective coaching diaries (nurses): qualitative assessment of feasibility/implementation and changes in attitudes/behaviors, analyzed with constant comparison.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2020

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

October 30, 2022

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Due to confidentiality and the risk of re-identification in this small sample, we will not publicly share qualitative interview/focus group transcripts, reflective diaries, or other qualitative materials. However, de-identified individual-participant quantitative data underlying the published results (e.g., COPM, DQoL, CES-D and other questionnaire outcomes), together with a data dictionary/codebook and the analytic code used for the published analyses, are available upon reasonable request.

IPD Sharing Time Frame

Starting at publication of the primary results; ending 5 years after publication.

IPD Sharing Access Criteria

Qualified researchers with a methodologically sound proposal may request access to de-identified individual-participant quantitative data underlying the published results, together with a data dictionary/codebook and the analytic code used for the published analyses. Requests will be reviewed by the study team and, if approved, data will be shared under a signed data use agreement (and ethics approval if required), via secure file transfer or a controlled-access repository.

IPD Sharing Supporting Information Type

  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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