An interventional study of Community-Based Occupational Therapy Intervention in Dementia, sponsored by University of Vic - Central University of Catalonia. Not yet recruiting at 1 site in Spain. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by University of Vic - Central University of Catalonia · Not applicable, Interventional, and Health services research
The goal of this feasibility pilot clinical trial is to evaluate the feasibility and acceptability of a community-based occupational therapy protocol for people living with dementia in community settings. The protocol was developed through a systematic review of occupational therapy interventions and a modified Delphi study to establish expert consensus regarding its therapeutic components and characteristics.
The main questions it aims to answer are:
Participants will:
This study will also provide preliminary information about potential changes in occupational outcomes following participation in the intervention.
The results of this pilot study will help optimize the intervention protocol and inform the design of future clinical trials evaluating its effectiveness in people living with dementia. In addition to quantitative outcome measures, participants' and caregivers' experiences of the intervention and study procedures will be collected to further evaluate intervention acceptability and identify potential barriers, facilitators, and areas for protocol refinement.
People living with dementia frequently experience progressive changes that affect their ability to participate in meaningful daily activities and maintain occupational performance while living in the community. Occupational therapy interventions may support meaningful participation in everyday life by addressing the individual needs, preferences, abilities, and environmental contexts of people living with dementia and their caregivers. Current evidence suggests that person-centered and occupation-based occupational therapy interventions may contribute to promoting occupational performance, participation, and quality of life among adults living with dementia (Smallfield et al., 2024).
However, occupational therapy interventions for people living with dementia are characterized by considerable heterogeneity regarding their therapeutic components, delivery methods, intervention intensity, care settings, and outcome measures. Existing evidence includes interventions delivered across community and residential settings that differ substantially in their characteristics and objectives, highlighting the need for evidence-informed intervention protocols that can be systematically developed and evaluated before their implementation in clinical practice (Uceda-Portillo et al., 2024).
The community-based occupational therapy protocol evaluated in this study was developed as part of a doctoral research project aimed at promoting meaningful participation among people living with dementia living in community settings. The development of the intervention protocol followed a sequential methodological process designed to ensure that the intervention is informed by current scientific evidence and expert consensus before evaluating its implementation in clinical practice.
This process included a systematic review of occupational therapy interventions for people living with dementia and a modified Delphi study involving a multidisciplinary panel of experts to establish consensus regarding the characteristics of the intervention protocol. The present study represents the next stage of this research process by evaluating the feasibility and acceptability of implementing the intervention protocol in community settings.
Community-based occupational therapy interventions for people living with dementia constitute complex interventions that require careful evaluation before undertaking larger clinical trials (Skivington et al., 2021). Feasibility pilot studies provide essential information regarding the implementation of interventions and study procedures and contribute to the planning, refinement, and optimization of future effectiveness studies (Eldridge et al., 2016).
Previous pilot studies evaluating occupational therapy interventions in people living with dementia have highlighted the importance of examining the applicability, implementation, and acceptability of interventions before their wider adoption in clinical practice (Pozzi et al., 2019).
This feasibility pilot clinical trial will provide information regarding the feasibility and acceptability of implementing the intervention protocol in community settings. In addition, the study will provide preliminary information about potential changes in occupational outcomes following participation in the intervention. These findings are intended to inform the refinement of the intervention protocol and contribute to the planning of future clinical trials rather than to establish the clinical effectiveness of the intervention.
The primary objectives of this feasibility pilot clinical trial are to:
This study will also provide preliminary information about potential changes in occupational outcomes following participation in the intervention, including occupational performance, participation in meaningful daily activities, and satisfaction with occupational performance.
The findings of this feasibility pilot clinical trial will contribute to the refinement and optimization of the intervention protocol and provide essential information for planning future clinical trials evaluating its clinical effectiveness. Finally, this study aims to support the development of evidence-informed, person-centered, and community-based occupational therapy interventions for people living with dementia and facilitate their future translation into clinical practice.
The results of this pilot study will help optimize the intervention protocol and inform the design of future clinical trials evaluating its effectiveness in people living with dementia. In addition to quantitative outcome measures, participants' and caregivers' experiences of the intervention and study procedures will be collected to further evaluate intervention acceptability and identify potential barriers, facilitators, and areas for protocol refinement.
2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.
This study's planned enrollment of 48 is below the median of 90 across 1,758 interventional studies indexed under Dementia.
Browse Dementia studies →University of Vic - Central University of Catalonia is the lead sponsor of 38 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Inclusion Criteria for People Living With Dementia:
Inclusion Criteria for Caregivers:
Exclusion Criteria for People Living with Dementia:
Exclusion Criteria for Caregivers:
- Inability to complete the essential study procedures required by the intervention or assessment protocol.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this arm will receive the community-based occupational therapy intervention delivered according to the study protocol. The intervention is person-centered and combines individual and group-based components designed to promote meaningful participation in everyday life among community-dwelling people living with dementia and their caregivers. The intervention will be delivered in community settings by occupational therapists following standardized study procedures.
Behavioral: Community-Based Occupational Therapy Intervention
Participants assigned to this arm will continue to receive their usual health and social care services available in the community during the study period. No additional occupational therapy intervention associated with the study protocol will be provided.
The community-based occupational therapy intervention is a person-centered and occupation-based program designed for community-dwelling people living with dementia and their caregivers. The intervention is delivered over approximately 8 to 10 weeks and combines individual and group-based components implemented in community settings according to a standardized study protocol. Participants receive between 10 and 14 intervention sessions, including individual sessions involving the person with dementia and their caregiver and group sessions designed to promote meaningful participation in everyday life. Caregivers also participate in group sessions addressing their needs within the intervention framework. All intervention components are delivered by occupational therapists following standardized study procedures.
Recruitment and retention
Recruitment will be assessed as the number and proportion of eligible participants who consent to participate in the study. Retention will be assessed as the number and proportion of participants who complete the intervention and post-intervention assessments. Furthermore, feasibility will be evaluated using the Feasibility of Intervention Measure (FIM), a 4-item measure rated on a 5-point scale from 1 (completely disagree) to 5 (completely agree). The score is the mean of the four items and ranges from 1 to 5, with higher scores indicating greater perceived feasibility.
Time frame: From enrollment to completion of post-intervention assessments (approximately 8-10 weeks).
Adherence
Intervention adherence will be assessed by participant attendance and completion of the intervention components delivered according to the study protocol.
Time frame: Throughout the intervention period (approximately 8-10 weeks).
Acceptability
Intervention acceptability will be evaluated among participants and caregivers following completion of the intervention using qualitative feedback regarding their experiences with the intervention and study procedures, including perceived benefits, barriers to participation, and suggestions for improvement. Furthermore, acceptability will be evaluated using the Acceptability of Intervention Measure (AIM), a 4-item measure rated on a 5-point scale from 1 (completely disagree) to 5 (completely agree). The score is the mean of the four items and ranges from 1 to 5, with higher scores indicating greater perceived acceptability.
Time frame: Post-intervention (approximately 8-10 weeks).
Protocol Implementation
The implementation of the intervention protocol will be assessed by documenting the successful delivery of the planned intervention components and recording any deviations from the study protocol throughout the study period.
Time frame: Throughout the intervention period (approximately 8-10 weeks).
Meaningful Participation (Engagement in Meaningful Activities Survey)
Meaningful participation will be assessed using the Engagement in Meaningful Activities Survey (EMAS). The EMAS evaluates the extent to which individuals perceive their daily activities as meaningful, personally valued, and consistent with their sense of competence, identity, and purpose in everyday life. The EMAS consists of 12 items rated on a 5-point scale from 1 (never) to 5 (always). The total score ranges from 12 to 60, with higher scores indicating greater engagement in meaningful activities.
Time frame: Baseline, post-intervention (approximately 8-10 weeks), and one-month follow-up.
Occupational Performance (Canadian Occupational Performance Measure)
Occupational performance will be assessed using the performance score of the Canadian Occupational Performance Measure (COPM). The COPM is a person-centered and occupation-based measure that evaluates participants' perceived performance in individually identified meaningful occupations. Performance is rated from 1 (not able to do it at all) to 10 (able to do it extremely well) for each identified occupational problem, and the score is the mean across problems, with higher scores indicating better perceived performance.
Time frame: Baseline, post-intervention (approximately 8-10 weeks), and one-month follow-up.
Satisfaction With Occupational Performance (Canadian Occupational Performance Measure)
Satisfaction with occupational performance will be assessed using the satisfaction score of the Canadian Occupational Performance Measure (COPM). The COPM evaluates participants' satisfaction with their performance in individually identified meaningful occupations. Satisfaction is rated from 1 (not satisfied at all) to 10 (extremely satisfied) for each identified problem, and the score is the mean across problems, with higher scores indicating greater satisfaction.
Time frame: Baseline, post-intervention (approximately 8-10 weeks), and one-month follow-up.
Caregiver's Sense of Competence (Short Sense of Competence Questionnaire)
Caregiver's sense of competence will be assessed using the Short Sense of Competence Questionnaire (S-SCQ). The S-SCQ is a 7-item questionnaire that evaluates caregivers' perceived competence in dealing with the burden of caregiving for a person with dementia. Each item is rated on a 5-point Likert-type scale from 1 (completely agree) to 5 (completely disagree). The total score ranges from 7 to 35, with higher scores indicating a greater sense of competence.
Time frame: Baseline, post-intervention (approximately 8-10 weeks), and one-month follow-up.
Caregiver-rated Functional Dependence and Caregiver Upset
Caregiver-rated functional dependence of the person with dementia and caregiver upset will be assessed using the Caregiver Assessment of Function and Upset (CAFU), a 15-item measure covering 8 instrumental and 7 basic activities of daily living. For each activity, the caregiver rates the level of assistance needed on a 7-point scale, which is reverse-coded for analysis so that 1 indicates complete independence and 7 indicates total assistance. Mean dependence scores are calculated separately for instrumental and basic activities (range 1 to 7), with higher scores indicating greater dependence. For each activity in which assistance is provided, the caregiver rates their upset from 0 (not at all) to 4 (extremely). Total upset scores range from 0 to 32 for instrumental activities and from 0 to 28 for basic activities, with higher scores indicating greater upset.
Time frame: Baseline, post-intervention (approximately 8-10 weeks), and one-month follow-up.
Plan to share: Yes — Individual de-identified participant data underlying the results reported in publications arising from this study will be shared. This includes de-identified demographic, clinical, feasibility, acceptability, and outcome measure data collected as part of the study protocol that are necessary to interpret and reproduce the published findings
Time frame: Data will be available beginning 12 months following publication of the primary study results and will remain available for 36 months
Access criteria: Data will be made available through the institutional repository of the University of Vic - Central University of Catalonia (UVic-UCC). Requests should be directed to aitor.pineiro@uvic.cat and must include a research proposal. Proposals will be reviewed by the study team to confirm that the request aligns with the consent provided by participants and complies with applicable data protection regulations
Start is estimated for Jan 2027; primary completion for Jun 2027, 5 months later.
Of 855 non-industry interventional studies with no phase under Dementia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 5 months is below that.
Counting every sponsor, half of 901 studies reached it within 25 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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University of Vic - Central University of Catalonia