NCT07347639

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 30, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

2.1 years

First QC Date

January 8, 2026

Last Update Submit

January 8, 2026

Conditions

Keywords

SOCAVCaregiversPrimary careNursing carePerson-centered careFeasibility study

Outcome Measures

Primary Outcomes (2)

  • Canadian Occupational Performance Measure

    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

    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 Outcomes (2)

  • The Dementia Quality of Life (DQoL)

    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),

    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 Outcomes (1)

  • Reflective coaching diaries

    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).

Study Arms (1)

SOCAV-Home Care intervention arm

OTHER

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.

Behavioral: SOCAV-Home Care (self-directed care support for home-dwelling people with dementia)

Interventions

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.

Also known as: SOCAV program, SOCAV home care
SOCAV-Home Care intervention arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • People with dementia were excluded if they had a Geriatric Depression Scale (GDS) score \>6;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avoord

Etten-Leur, North Brabant, 4876 CV, Netherlands

Location

Related Publications (2)

  • 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

    BACKGROUND
  • Das P, Douma G, Donkers H, Roets-Merken L, Graff M. SOCAV: a nurse-led support programme for self-direction in people with dementia receiving home care, involving informal caregivers - a feasibility study with process evaluation in the Netherlands. BMJ Open. 2026 Mar 18;16(3):e105939. doi: 10.1136/bmjopen-2025-105939.

Related Links

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Not applicable. This was a single-arm feasibility study and no additional parties were formally masked/blinded; participants (people with dementia and informal caregivers), nurses, peer coaches, and the research team were aware of the intervention. Interviewers were independent/unknown to participants, but they were not blinded to intervention exposure.
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: This is a single-group, non-randomized feasibility study with a longitudinal pre-post evaluation and embedded process evaluation. All enrolled participants received the SOCAV-Home Care program (there was no control or comparison arm). The intervention was delivered at the level of the home-care team/nurses (training plus ongoing reflective coaching over approximately 6-9 months), with dyad-level components for the person with dementia and informal caregiver (a series of collaborative home meetings over approximately 3-6 months). Outcomes were assessed repeatedly over time (baseline and follow-up time points during the intervention period) to explore feasibility and signals of potential benefit rather than to test efficacy.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2026

First Posted

January 16, 2026

Study Start

August 30, 2020

Primary Completion

September 30, 2022

Study Completion

October 30, 2022

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
ICF, CSR, ANALYTIC CODE
Time Frame
Starting at publication of the primary results; ending 5 years after publication.
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.
More information

Locations