DementiaCOT-DNCT07905872
Feasibility of Community Occupational Therapy for Dementia (COT-D)
A study testing Community-Based Occupational Therapy Intervention in people with Dementia, run by University of Vic - Central University of Catalonia at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- What is being tested?
- Community-Based Occupational Therapy Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2027to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Clinical diagnosis of dementia.
- Mild to moderate dementia, corresponding to Global Deterioration Scale stages 4 or 5.
- Living in the community and not residing in a long-term care facility.
- Able to participate in individual and group sessions lasting approximately 45 to 60 minutes.
- Able to attend the community-based sessions with available support when needed.
- Able to provide informed consent or having a legally authorized representative who can provide consent in accordance with applicable regulations.
Show all 12Show fewer
- Having a primary caregiver who meets the caregiver eligibility criteria.
- Age 18 years or older.
- Identified as the primary caregiver of the participating person with dementia.
- Provides regular assistance or support in everyday life.
- Willing to participate in study assessments and the caregiver components of the intervention.
- Able to provide informed consent.
Who cannot join
- Severe behavioral or psychological symptoms that prevent safe participation.
- Acute or unstable medical or psychiatric condition that may interfere with participation.
- Severe uncorrected sensory or communication impairment that prevents participation despite reasonable accommodations.
- Concurrent participation in another intervention study likely to affect the study outcomes.
- Inability of the participant to complete the essential study procedures.
- Inability to complete the essential study procedures required by the intervention or assessment protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Asociación de Familiares de Enfermos de Alzheimer de la Rioja
Logroño, La Rioja, 26003
Aitor Piñeiro Gago, MSc, OT, +34629511103, aitor.pineiro@uvic.cat
About this study
Official title: Feasibility and Acceptability of Community-Based Occupational Therapy for People Living With Dementia
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:
Read more
- Is the community-based occupational therapy protocol feasible to implement for people living with dementia in community settings?
- Is the intervention acceptable to participants and their caregivers?
- Can the study procedures be successfully implemented to inform the design of future clinical trials?
Participants will:
- Receive the community-based occupational therapy intervention delivered according to the study protocol.
- Participate in study assessments throughout the intervention period.
- Provide information that will help researchers evaluate the feasibility and acceptability of the intervention and study procedures.
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.
Read the detailed description
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:
- Evaluate the feasibility of implementing the community-based occupational therapy intervention in community settings for people living with dementia.
- Evaluate the acceptability of the intervention and study procedures among participants and their caregivers.
- Determine whether the proposed study procedures can be successfully implemented to support the design of future clinical trials.
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.
- Conditions
- Dementia
- Being tested
- Community-Based Occupational Therapy Intervention
- Keywords
- dementia, occupational therapy, community-based occupational therapy, meaningful participation, occupational performance, person-centered care, pilot study, caregivers, activities of daily living, 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.
Community-Based Occupational Therapy InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Community-Based Occupational Therapy Intervention | Experimental | 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. Receives: Behavioral: Community-Based Occupational Therapy Intervention |
| Usual Care | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Throughout the intervention period (approximately 8-10 weeks).
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, post-intervention (approximately 8-10 weeks), and one-month follow-up.
Caregiver's Sense of Competence (Sense of Competence Questionnaire)
Caregiver's sense of competence will be assessed using the Sense of Competence Questionnaire (SCQ). The SCQ evaluates caregivers' perceived competence, satisfaction, and experiences related to their caregiving role.
Measured: Baseline, post-intervention (approximately 8-10 weeks), and one-month follow-up.
Caregiver-rated Functional Performance and Caregiver Upset
Caregiver-rated functional performance and caregiver upset will be assessed using the Caregiver Assessment of Function and Upset Scale (CAFU). The CAFU evaluates caregivers' perceptions of the functional performance of people living with dementia in everyday activities and the level of caregiver upset associated with providing assistance or supervision.
Measured: Baseline, post-intervention (approximately 8-10 weeks), and one-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm, parallel-group feasibility pilot clinical trial involving community-dwelling people living with dementia and their caregivers. Participants will be assigned to either a community-based occupational therapy intervention group or a control group. The intervention will be delivered in small groups of approximately 5 to 7 dyads. Recruitment and intervention delivery may be conducted in successive cohorts to increase the total sample size, with both study arms maintained across cohorts. Assessments will be completed at baseline, immediately after the intervention, and at one-month follow-up. The study will primarily evaluate feasibility and acceptability and will explore preliminary changes in occupational outcomes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vic - Central University of Catalonia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Ramon Aribau, PhD, Study chair, University of Vic - Central University of CataloniaJosé Antonio Merchán Baeza, PhD, Study chair, University of Vic - Central University of CataloniaAitor Piñeiro Gago, MSc, OT, Principal investigator, University of Vic - Central University of Catalonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905872
- Sponsor's protocol ID
- E-OR868DI52251
- Acronym
- COT-D
- Status last verified
- Oct 2026
- First submitted
- 14 Sep 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
Pozzi C, Lanzoni A, Lucchi E, Bergamini L, Bevilacqua P, Manni B, Garzetta G, Barbieri S, Khazri S, Chattat R, Graff M, Fabbo A, Morandi A. A pilot study of community-based occupational therapy for persons with dementia (COTID-IT Program) and their caregivers: evidence for applicability in Italy. Aging Clin Exp Res. 2019 Sep;31(9):1299-1304. doi: 10.1007/s40520-018-1078-7. Epub 2018 Nov 28.
PubMed 30488182Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.
PubMed 27777223Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.
PubMed 34593508Uceda-Portillo C, Aranda-Valero S, Moruno-Miralles P. Occupational Therapy Interventions to Improve the Quality of Life of Older Adults with Dementia Living in Nursing Homes: A Systematic Review. Healthcare (Basel). 2024 Apr 25;12(9):896. doi: 10.3390/healthcare12090896.
PubMed 38727453Smallfield S, Metzger L, Green M, Henley L, Rhodus EK. Occupational Therapy Practice Guidelines for Adults Living With Alzheimer's Disease and Related Neurocognitive Disorders. Am J Occup Ther. 2024 Jan 1;78(1):7801397010. doi: 10.5014/ajot.2024.078101.
PubMed 38306186
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Community-Based Occupational Therapy for People Living With Dementia
- ClinicalTrials.gov ID
- NCT07905872
- Acronym / sponsor ID
- COT-D / E-OR868DI52251
- Conditions
- Dementia
- Keywords
- dementia, occupational therapy, community-based occupational therapy, meaningful participation, occupational performance, person-centered care, pilot study, caregivers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of Vic - Central University of CataloniaUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 30 Oct 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.
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:
- Is the community-based occupational therapy protocol feasible to implement for people living with dementia in community settings?
- Is the intervention acceptable to participants and their caregivers?
- Can the study procedures be successfully implemented to inform the design of future clinical trials?
Participants will:
- Receive the community-based occupational therapy intervention delivered according to the study protocol.
- Participate in study assessments throughout the intervention period.
- Provide information that will help researchers evaluate the feasibility and acceptability of the intervention and study procedures.
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.
Detailed description
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:
- Evaluate the feasibility of implementing the community-based occupational therapy intervention in community settings for people living with dementia.
- Evaluate the acceptability of the intervention and study procedures among participants and their caregivers.
- Determine whether the proposed study procedures can be successfully implemented to support the design of future clinical trials.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel-group feasibility pilot clinical trial involving community-dwelling people living with dementia and their caregivers. Participants will be assigned to either a community-based occupational therapy intervention group or a control group. The intervention will be delivered in small groups of approximately 5 to 7 dyads. Recruitment and intervention delivery may be conducted in successive cohorts to increase the total sample size, with both study arms maintained across cohorts. Assessments will be completed at baseline, immediately after the intervention, and at one-month follow-up. The study will primarily evaluate feasibility and acceptability and will explore preliminary changes in occupational outcomes.
| Arm | Type | Receives |
|---|---|---|
| Community-Based Occupational Therapy Intervention | Experimental | Behavioral: Community-Based Occupational Therapy InterventionParticipants 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. |
| Usual Care | No 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Clinical diagnosis of dementia.
- Mild to moderate dementia, corresponding to Global Deterioration Scale stages 4 or 5.
- Living in the community and not residing in a long-term care facility.
- Able to participate in individual and group sessions lasting approximately 45 to 60 minutes.
- Able to attend the community-based sessions with available support when needed.
Key exclusion criteria (6 listed)
- Severe behavioral or psychological symptoms that prevent safe participation.
- Acute or unstable medical or psychiatric condition that may interfere with participation.
- Severe uncorrected sensory or communication impairment that prevents participation despite reasonable accommodations.
- Concurrent participation in another intervention study likely to affect the study outcomes.
- Inability of the participant to complete the essential study procedures.
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 |
|---|---|---|
| Community-Based Occupational Therapy InterventionThe 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. | Behavioural | Community-Based Occupational Therapy Intervention |
Primary outcome
Recruitment and retention
Time frame: From enrollment to completion of post-intervention assessments (approximately 8-10 weeks).
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).
Adherence
Time frame: Throughout the intervention period (approximately 8-10 weeks).
Intervention adherence will be assessed by participant attendance and completion of the intervention components delivered according to the study protocol.
Acceptability
Time frame: Post-intervention (approximately 8-10 weeks).
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).
Protocol Implementation
Time frame: Throughout the intervention period (approximately 8-10 weeks).
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.
5 secondary outcomes
Meaningful Participation (Engagement in Meaningful Activities Survey)
Time frame: Baseline, post-intervention (approximately 8-10 weeks), and one-month follow-up.
Occupational Performance (Canadian Occupational Performance Measure)
Time frame: Baseline, post-intervention (approximately 8-10 weeks), and one-month follow-up.
Satisfaction With Occupational Performance (Canadian Occupational Performance Measure)
Time frame: Baseline, post-intervention (approximately 8-10 weeks), and one-month follow-up.
Caregiver's Sense of Competence (Sense of Competence Questionnaire)
Time frame: Baseline, post-intervention (approximately 8-10 weeks), and one-month follow-up.
Caregiver-rated Functional Performance and Caregiver Upset
Time frame: Baseline, post-intervention (approximately 8-10 weeks), and one-month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 30488182Pozzi C, Lanzoni A, Lucchi E, Bergamini L, Bevilacqua P, Manni B, Garzetta G, Barbieri S, Khazri S, Chattat R, Graff M, Fabbo A, Morandi A. A pilot study of community-based occupational therapy for persons with dementia (COTID-IT Program) and their caregivers: evidence for applicability in Italy. Aging Clin Exp Res. 2019 Sep;31(9):1299-1304. doi: 10.1007/s40520-018-1078-7. Epub 2018 Nov 28.
- Background: PubMed 27777223Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.
- Background: PubMed 34593508Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.
- Background: PubMed 38727453Uceda-Portillo C, Aranda-Valero S, Moruno-Miralles P. Occupational Therapy Interventions to Improve the Quality of Life of Older Adults with Dementia Living in Nursing Homes: A Systematic Review. Healthcare (Basel). 2024 Apr 25;12(9):896. doi: 10.3390/healthcare12090896.
- Background: PubMed 38306186Smallfield S, Metzger L, Green M, Henley L, Rhodus EK. Occupational Therapy Practice Guidelines for Adults Living With Alzheimer's Disease and Related Neurocognitive Disorders. Am J Occup Ther. 2024 Jan 1;78(1):7801397010. doi: 10.5014/ajot.2024.078101.
- Individual participant dataSharing planned: 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
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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.
Anna Ramon Aribau, PhD study chair
University of Vic - Central University of Catalonia
José Antonio Merchán Baeza, PhD study chair
University of Vic - Central University of Catalonia
Aitor Piñeiro Gago, MSc, OT principal investigator
University of Vic - Central University of Catalonia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-Based Occupational Therapy Intervention in people with Dementia, run by University of Vic - Central University of Catalonia at 1 site in Spain.
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 12 inclusion and 6 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: opening soon, as of the sponsor's last update on 30 Oct 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aitor Piñeiro Gago, MSc, OT (+34629511103, aitor.pineiro@uvic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and retention (time frame: From enrollment to completion of post-intervention assessments (approximately 8-10 weeks).). The study lists 4 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 NCT07905872, which also lists 5 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 30 Oct 2026.