DementiaCOPECTNCT02365051
Translation of COPE for Publicly-Funded Home Care Clients and Their Families
A study testing Care of Persons with Dementia in their Environments in people with Dementia and Alzheimer's Disease, run by UConn Health at 1 site in United States.
Trial summary
This community-based translational trial tests the value of a proven non-pharmacologic intervention for older adults living with dementia and informal caregivers when this intervention is incorporated into a publicly-funded home and community based service program. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Alzheimer's Disease
- What is being tested?
- Care of Persons with Dementia in their Environments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 582 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 30 Sep 2019
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Active client in publicly-funded home care program; Diagnosis of Alzheimer's disease or other dementia OR >=4 errors on the Mental Status Questionnaire; speaks or understands English
Who cannot join
- Diagnosed schizophrenia or bipolar disorder; bedbound; participation in experimental drug study to treat agitation; home environment deemed unsafe or unsanitary.
Trial locations and contacts
1 site in 1 country.
United States1 site
UConn Center on Aging
Farmington, Connecticut, 06030-5215
About this study
This community-based translational trial tests the value of a proven non-pharmacologic intervention for older adults living with dementia and informal caregivers when this intervention is incorporated into a publicly-funded home and community based service program. Half the participants will receive customary publicly-funded services alone, and half will receive customary services plus the proven non-pharmacologic intervention.
Read the detailed description
More than 5 million Americans have dementia and more than 15 million Americans, mostly family members, provide unpaid care to these individuals. In the absence of a cure or widely effective pharmacotherapy to combat dementia, translation and implementation of efficacious non-pharmacologic interventions into existing service programs are sorely needed. The Connecticut Home Care Program for Elders (CHCPE), a Medicaid waiver and state revenue-funded program for older adults at high risk for nursing home admission, provides in-home and community-based services coordinated by care managers. In this translational study, an evidence-based intervention, Care of Persons with Dementia in their Environments (COPE), is incorporated into the CHCPE. COPE is an efficacious 4-month, in-home, non-pharmacologic intervention using occupational therapists and advanced practice nurses to maximize physical function in older adults with dementia and to improve dementia management skills of family caregivers (CG).
This trial will randomly assign 290 CHCPE clients with dementia and their CGs to receive either COPE plus customary CHCPE services, or customary CHCPE services alone. The main study outcome measures are similar to those of the original COPE efficacy trial. To maximize the translational effort, this study also will: conduct a formal cost-benefit analysis to determine the potential economic benefit of adding COPE to customary CHCPE services; evaluate the feasibility and acceptability of COPE as a new CHCPE service; and establish an expert Translational Advisory Committee to help develop and guide COPE dissemination plans for implementation nationally.
Study aims for CHCPE clients:
Aim 1.1: Determine COPE effect on functional dependence 4 months after randomization (primary study endpoint).
Aim 1.2: Determine COPE effects on engagement in activities, quality of life, and NPS, 4 months after randomization.
Aim 1.3: Determine COPE effects on functional dependence, engagement in activities, quality of life, and neuropsychiatric symptoms (NPS), 12 months after randomization.
We hypothesize that CHCPE clients receiving COPE will show greater reduction in functional dependence, greater engagement in activities, better quality of life, and fewer neuropsychiatric symptoms, compared to controls, 4 months and 12 months after randomization.
Study aims for CGs:
Aim 2.1: Determine COPE effect on perceived CG well-being 4 months after randomization.
Aim 2.2: Determine COPE effects on CG confidence in using dementia management strategies 4 months after randomization.
Aim 2.3: Determine COPE effects on CG perceived well-being, confidence in using activities, and ability to keep client at home, 12 months after randomization.
We hypothesize that COPE CGs will report improvement in all specified outcomes compared to controls, 4 and 12 months after randomization.
Translational study aims:
Aim 3.1: Determine the net financial benefit of COPE, accounting for COPE intervention costs, CHCPE usual care costs, nursing home costs, and other service costs, 4 months and 12 months after randomization. The 12 month cost-benefit analysis will test whether financial benefits of COPE accrue over a longer time horizon than the 4-month intervention period.
Aim 3.2: Determine the feasibility and acceptability of COPE implementation into the CHCPE from multiple stakeholder viewpoints, including CHCPE care managers and state Medicaid and public policy decision makers.
- Conditions
- Dementia, Alzheimer's Disease
- Being tested
- Care of Persons with Dementia in their Environments
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care of Persons with Dementia in their EnvironmentsBehavioural
Also called COPE
In-home visits by occupational therapist and advanced practice nurse.
| Study group | Role | What they receive |
|---|---|---|
| usual care | No intervention | Older adults with dementia and their family caregivers receive all services for which they are eligible in the Connecticut Home Care Program for Elders. |
| COPE plus usual care | Experimental | Older adults with dementia and their family caregivers receive Usual care plus the intervention: Care of Persons with Dementia in their Environments. Receives: Behavioral: Care of Persons with Dementia in their Environments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional dependence
The metric for the primary outcome measure is score on the 15-item Caregiver Assessment of Function and Upset (CAFU) measure. The CAFU is adapted from the Functional Independence Measure; each of the 15 items is an activity of daily living (ADL) or instrumental activity of daily living (IADL). Each ADL and IADL item is scored on a 7-point scale ranging from completely independent (score of 7) to needing complete help (score of 1). Person-level functional dependence scores are calculated by summing scores across all items and dividing by the number of items.
Measured: Change in functional dependence score between baseline (pre-randomization) and 4 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startMay 2015
- Primary completion1 Mar 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fortinsky, Richard, UConn Health
- Investigators
- Richard H Fortinsky, PhD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365051
- Sponsor's protocol ID
- 15-014-3
- Acronym
- COPECT
- Status last verified
- Jun 2023
- First submitted
- 26 Jan 2015
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Study results will be disseminated through peer-reviewed publications and presentations at national meetings in gerontology, geriatrics, public health, occupational therapy and nursing. Research-quality data which documents, supports and validates research findings will be made publicly available after main findings from the final research data set have been accepted for publication. Such data will be completely de-identified to prevent disclosure of individual study participant information, and will be shared on electronic media. We will request a data-sharing agreement that provides for a commitment to using the data only for research purposes, securing the data using appropriate computer technology, not redistributed to third parties, destroying or returning the data after analyses are completed, and a proper acknowledgement of the data resource.
Publications
Fortinsky RH, Gitlin LN, Pizzi LT, Piersol CV, Grady J, Robison JT, Molony S. Translation of the Care of Persons with Dementia in their Environments (COPE) intervention in a publicly-funded home care context: Rationale and research design. Contemp Clin Trials. 2016 Jul;49:155-65. doi: 10.1016/j.cct.2016.07.006. Epub 2016 Jul 6.
PubMed 27394383Fortinsky RH, Gitlin LN, Pizzi LT, Piersol CV, Grady J, Robison JT, Molony S, Wakefield D. Effectiveness of the Care of Persons With Dementia in Their Environments Intervention When Embedded in a Publicly Funded Home- and Community-Based Service Program. Innov Aging. 2020 Oct 26;4(6):igaa053. doi: 10.1093/geroni/igaa053. eCollection 2020.
PubMed 33367114Pizzi LT, Jutkowitz E, Prioli KM, Lu EY, Babcock Z, McAbee-Sevick H, Wakefield DB, Robison J, Molony S, Piersol CV, Gitlin LN, Fortinsky RH. Cost-Benefit Analysis of the COPE Program for Persons Living With Dementia: Toward a Payment Model. Innov Aging. 2021 Oct 16;6(1):igab042. doi: 10.1093/geroni/igab042. eCollection 2022.
PubMed 35047708Kellett K, Robison J, McAbee-Sevick H, Gitlin LN, Verrier Piersol C, Fortinsky RH. Implementing the Care of Persons With Dementia in Their Environments (COPE) Intervention in Community-Based Programs: Acceptability and Perceived Benefit From Care Managers' and Interventionists' Perspectives. Gerontologist. 2023 Jan 24;63(1):28-39. doi: 10.1093/geront/gnac068.
PubMed 35581164
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation of COPE for Publicly-Funded Home Care Clients and Their Families
- ClinicalTrials.gov ID
- NCT02365051
- Acronym / sponsor ID
- COPECT / 15-014-3
- Conditions
- Dementia, Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 582 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 18 Feb 2015 (estimated)
- 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.
This community-based translational trial tests the value of a proven non-pharmacologic intervention for older adults living with dementia and informal caregivers when this intervention is incorporated into a publicly-funded home and community based service program. Half the participants will receive customary publicly-funded services alone, and half will receive customary services plus the proven non-pharmacologic intervention.
Detailed description
More than 5 million Americans have dementia and more than 15 million Americans, mostly family members, provide unpaid care to these individuals. In the absence of a cure or widely effective pharmacotherapy to combat dementia, translation and implementation of efficacious non-pharmacologic interventions into existing service programs are sorely needed. The Connecticut Home Care Program for Elders (CHCPE), a Medicaid waiver and state revenue-funded program for older adults at high risk for nursing home admission, provides in-home and community-based services coordinated by care managers. In this translational study, an evidence-based intervention, Care of Persons with Dementia in their Environments (COPE), is incorporated into the CHCPE. COPE is an efficacious 4-month, in-home, non-pharmacologic intervention using occupational therapists and advanced practice nurses to maximize physical function in older adults with dementia and to improve dementia management skills of family caregivers (CG).
This trial will randomly assign 290 CHCPE clients with dementia and their CGs to receive either COPE plus customary CHCPE services, or customary CHCPE services alone. The main study outcome measures are similar to those of the original COPE efficacy trial. To maximize the translational effort, this study also will: conduct a formal cost-benefit analysis to determine the potential economic benefit of adding COPE to customary CHCPE services; evaluate the feasibility and acceptability of COPE as a new CHCPE service; and establish an expert Translational Advisory Committee to help develop and guide COPE dissemination plans for implementation nationally.
Study aims for CHCPE clients:
Aim 1.1: Determine COPE effect on functional dependence 4 months after randomization (primary study endpoint).
Aim 1.2: Determine COPE effects on engagement in activities, quality of life, and NPS, 4 months after randomization.
Aim 1.3: Determine COPE effects on functional dependence, engagement in activities, quality of life, and neuropsychiatric symptoms (NPS), 12 months after randomization.
We hypothesize that CHCPE clients receiving COPE will show greater reduction in functional dependence, greater engagement in activities, better quality of life, and fewer neuropsychiatric symptoms, compared to controls, 4 months and 12 months after randomization.
Study aims for CGs:
Aim 2.1: Determine COPE effect on perceived CG well-being 4 months after randomization.
Aim 2.2: Determine COPE effects on CG confidence in using dementia management strategies 4 months after randomization.
Aim 2.3: Determine COPE effects on CG perceived well-being, confidence in using activities, and ability to keep client at home, 12 months after randomization.
We hypothesize that COPE CGs will report improvement in all specified outcomes compared to controls, 4 and 12 months after randomization.
Translational study aims:
Aim 3.1: Determine the net financial benefit of COPE, accounting for COPE intervention costs, CHCPE usual care costs, nursing home costs, and other service costs, 4 months and 12 months after randomization. The 12 month cost-benefit analysis will test whether financial benefits of COPE accrue over a longer time horizon than the 4-month intervention period.
Aim 3.2: Determine the feasibility and acceptability of COPE implementation into the CHCPE from multiple stakeholder viewpoints, including CHCPE care managers and state Medicaid and public policy decision makers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual care | No intervention | –Older adults with dementia and their family caregivers receive all services for which they are eligible in the Connecticut Home Care Program for Elders. |
| COPE plus usual care | Experimental | Behavioral: Care of Persons with Dementia in their EnvironmentsOlder adults with dementia and their family caregivers receive Usual care plus the intervention: Care of Persons with Dementia in their Environments. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Active client in publicly-funded home care program; Diagnosis of Alzheimer's disease or other dementia OR >=4 errors on the Mental Status Questionnaire; speaks or understands English
Key exclusion criteria (1 listed)
- Diagnosed schizophrenia or bipolar disorder; bedbound; participation in experimental drug study to treat agitation; home environment deemed unsafe or unsanitary.
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 |
|---|---|---|
| Care of Persons with Dementia in their EnvironmentsAlso: COPEIn-home visits by occupational therapist and advanced practice nurse. | Behavioural | COPE plus usual care |
Primary outcome
Functional dependence
Time frame: Change in functional dependence score between baseline (pre-randomization) and 4 months post-randomization
The metric for the primary outcome measure is score on the 15-item Caregiver Assessment of Function and Upset (CAFU) measure. The CAFU is adapted from the Functional Independence Measure; each of the 15 items is an activity of daily living (ADL) or instrumental activity of daily living (IADL). Each ADL and IADL item is scored on a 7-point scale ranging from completely independent (score of 7) to needing complete help (score of 1). Person-level functional dependence scores are calculated by summing scores across all items and dividing by the number of items.
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 6 Jun 2023.
- Results publication: PubMed 27394383Fortinsky RH, Gitlin LN, Pizzi LT, Piersol CV, Grady J, Robison JT, Molony S. Translation of the Care of Persons with Dementia in their Environments (COPE) intervention in a publicly-funded home care context: Rationale and research design. Contemp Clin Trials. 2016 Jul;49:155-65. doi: 10.1016/j.cct.2016.07.006. Epub 2016 Jul 6.
- Results publication: PubMed 33367114Fortinsky RH, Gitlin LN, Pizzi LT, Piersol CV, Grady J, Robison JT, Molony S, Wakefield D. Effectiveness of the Care of Persons With Dementia in Their Environments Intervention When Embedded in a Publicly Funded Home- and Community-Based Service Program. Innov Aging. 2020 Oct 26;4(6):igaa053. doi: 10.1093/geroni/igaa053. eCollection 2020.
- Results publication: PubMed 35047708Pizzi LT, Jutkowitz E, Prioli KM, Lu EY, Babcock Z, McAbee-Sevick H, Wakefield DB, Robison J, Molony S, Piersol CV, Gitlin LN, Fortinsky RH. Cost-Benefit Analysis of the COPE Program for Persons Living With Dementia: Toward a Payment Model. Innov Aging. 2021 Oct 16;6(1):igab042. doi: 10.1093/geroni/igab042. eCollection 2022.
- Results publication: PubMed 35581164Kellett K, Robison J, McAbee-Sevick H, Gitlin LN, Verrier Piersol C, Fortinsky RH. Implementing the Care of Persons With Dementia in Their Environments (COPE) Intervention in Community-Based Programs: Acceptability and Perceived Benefit From Care Managers' and Interventionists' Perspectives. Gerontologist. 2023 Jan 24;63(1):28-39. doi: 10.1093/geront/gnac068.
- Individual participant dataSharing planned: Yes. Study results will be disseminated through peer-reviewed publications and presentations at national meetings in gerontology, geriatrics, public health, occupational therapy and nursing. Research-quality data which documents, supports and validates research findings will be made publicly available after main findings from the final research data set have been accepted for publication. Such data will be completely de-identified to prevent disclosure of individual study participant information, and will be shared on electronic media. We will request a data-sharing agreement that provides for a commitment to using the data only for research purposes, securing the data using appropriate computer technology, not redistributed to third parties, destroying or returning the data after analyses are completed, and a proper acknowledgement of the data resource.
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
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.
Richard H Fortinsky, PhD principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care of Persons with Dementia in their Environments in people with Dementia and Alzheimer's Disease, run by UConn Health at 1 site in United States.
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 1 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 6 Jun 2023. 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 United States. 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?
Functional dependence (time frame: Change in functional dependence score between baseline (pre-randomization) and 4 months post-randomization). 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 NCT02365051, which also lists 4 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 6 Jun 2023.