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Completed

NCT Number: NCT07347639

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

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Dementia Caregivers Mental Disorders Nervous System Diseases Neurocognitive Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Avoord

Etten-Leur, North Brabant, 4876 CV, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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

Behavioral

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

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study 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

Acronym: SOCAV-program

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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