DementiaSOCAV-programNCT07347639
SOCAV: a Nurse-led Support Programme for Self-direction in People With Dementia
A study testing SOCAV-Home Care (self-directed care support for home-dwelling people with dementia) in people with Dementia and Dementia Caregivers, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia, Dementia Caregivers
- What is being tested?
- SOCAV-Home Care (self-directed care support for home-dwelling people with dementia)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Aug 2020to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- People with dementia were excluded if they had a Geriatric Depression Scale (GDS) score >6;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Dementia, Dementia Caregivers
- Being tested
- SOCAV-Home Care (self-directed care support for home-dwelling people with dementia)
- Keywords
- SOCAV, Caregivers, Primary care, Nursing care, Person-centered care, Feasibility study
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOCAV-Home Care (self-directed care support for home-dwelling people with dementia)Behavioural
Also called SOCAV program, SOCAV home care
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: SOCAV-Home Care (self-directed care support for home-dwelling people with dementia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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 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.
Measured: 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),
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start30 Aug 2020
- Primary completion30 Sep 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347639
- Sponsor's protocol ID
- MEC A-N 2019-5689
- Acronym
- SOCAV-program
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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
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.
PubMed 41857855
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07347639
- Acronym / sponsor ID
- SOCAV-program / MEC A-N 2019-5689
- Conditions
- Dementia, Dementia Caregivers
- Keywords
- SOCAV, Caregivers, Primary care, Nursing care, Person-centered care, Feasibility study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 30 Aug 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 16 Jan 2026 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| SOCAV-Home Care intervention arm | Other | Behavioral: SOCAV-Home Care (self-directed care support for home-dwelling people with dementia)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- People with dementia were excluded if they had a Geriatric Depression Scale (GDS) score >6;
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 |
|---|---|---|
| SOCAV-Home Care (self-directed care support for home-dwelling people with dementia)Also: SOCAV program, SOCAV home careSOCAV-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. | Behavioural | SOCAV-Home Care intervention arm |
Primary outcome
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
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.
2 secondary outcomes
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- BackgroundCorporaal, 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
- Derived from this study: PubMed 41857855Das 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.
- SOCAV helps people with dementia keep autonomy and meaningful daily activities. It trains family and professional caregivers to reflect, optimize, compensate and teach skills, supporting clients to live at home longer with enjoyment and dignity.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOCAV-Home Care (self-directed care support for home-dwelling people with dementia) in people with Dementia and Dementia Caregivers, run by Radboud University Medical Center at 1 site in Netherlands.
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 3 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: finished, as of the sponsor's last update on 16 Jan 2026. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07347639, which also lists 2 linked publications.
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 16 Jan 2026.