Dementia, MildNCT05187117
CAPABLE Family Pilot - Adapting CAPABLE for Older Adults With Mild Cognitive Impairment (MCI)/Early Stage Dementia and Their Care Partners
A study testing CAPABLE Family - Open Label Pilot in people with Dementia, Mild and Mild Cognitive Impairment, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to test the adapted protocol, CAPABLE Family which builds upon the evidenced based CAPABLE program to address older adults with co-occurring physical disability and mild cognitive impairment or early stage dementia and the older adults' caregivers. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Mild, Mild Cognitive Impairment, Disability Physical
- What is being tested?
- CAPABLE Family - Open Label Pilot
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2022to 15 Apr 2024
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have at least 1 ADL disability
- Have mild cognitive impairment or mild dementia (as indicated by clinician diagnosis, subjective cognitive complaints, or Blind/Telephone Montreal Cognitive Assessment (MoCA)(score of 16-23)
- Care partners will be included if they provide >10 hours of care/week
- Live in Baltimore City/County
Who cannot join
- Live in long term care setting
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Nursing
Baltimore, Maryland, 21205
About this study
Official title: CAPABLE Family Pilot
The purpose of this study is to test the adapted protocol, CAPABLE Family which builds upon the evidenced based CAPABLE program to address older adults with co-occurring physical disability and mild cognitive impairment or early stage dementia and the older adults' caregivers. It will consist of two phases - an open label pilot and waitlist control trial.
Read the detailed description
CAPABLE (NA_00031539) is an evidence-based program that reduces physical disability, but was designed for people who are cognitively intact.
The investigators seek to adapt CAPABLE to meet the needs of older adults with physical disability and mild cognitive impairment and early stage dementia. The investigators also seek to meet the needs of family members who serve as informal caregivers in relation to the physical function of those with cognitive impairment. The purpose of this pilot study is to test a new protocol for a new program, CAPABLE Family, to address older adults with co-occurring physical disability and dementia and the older adults' caregivers.
CAPABLE is a multicomponent goal-directed program that reduces physical disability by working with the person and environment, but was designed for people who are cognitively intact. Based on the Centers for Medicare and Medicaid (CMS) request, the investigators' team briefly included people with mild dementia in the regular CAPABLE protocol. Looking back on that preliminary data, the investigators identified a subset of 12 older adults with mild dementia with Mini-Mental State Examination (MMSE) scores of 23 or below. The investigators found that more than half improved in Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) which is promising but much lower than CAPABLE the rest of the cohorts which suggests the need to adapt CAPABLE for people with dementia. Therefore, the investigators have adapted CAPABLE for people with mild cognitive impairment or early stage dementia calling it CAPABLE Family.
As in CAPABLE (NA_00031539), the delivery characteristics of CAPABLE Family consist of an assessment-driven, individually tailored package of interventions delivered over the course of 4 months by an occupational therapist (OT) (~6 home visits for ≤ 1hour), a registered nurse (RN) (~4 home visits for ≤ 1hour) and a handy worker (HW).
This research study is a continuation of IRB00243117 during which the investigators conducted preliminary activities to design the CAPABLE Family intervention. This study will include two phases, an open label pilot and a randomized control trial. The investigators will collect feedback during the open label pilot from the study team clinicians, older adult participants and care partners to further refine the intervention that will be tested as part of the randomized control trial.
- Conditions
- Dementia, Mild, Mild Cognitive Impairment, Disability Physical, Impairment, Cognitive, Caregiver Burden, Quality of Life
- Being tested
- CAPABLE Family - Open Label Pilot, CAPABLE Family - Randomized Control Trial
- Keywords
- Activities of Daily Living, Instrumental Activities of Daily Living, Caregiving, Physical Function, Executive Function, Home, Intervention, Mild Cognitive Impairment, Early Dementia
- Medical subject headings
- Dementia, Lymphoma, Follicular, Cognitive Dysfunction, Caregiver Burden, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPABLE Family - Open Label PilotBehavioural
As in CAPABLE (NA_00031539), the delivery characteristics of CAPABLE Family consist of an assessment-driven, individually tailored package of interventions delivered over the course of 4 months by an occupational therapist (OT) (~6 home visits for ≤ 1hour), a registered nurse (RN) (~4 home visits for ≤ 1hour) and a handy worker (HW).
Adaptations for cognitive decline will be made on a per-client basis as part of the open-label pilot. Topics of adaptations include problem areas addresses, care partner involvement, length/frequency of visits, types of assessments and questions asked, and brainstorming/action planning structure.
CAPABLE Family - Randomized Control TrialBehavioural
As in CAPABLE (NA_00031539), the delivery characteristics of CAPABLE Family consist of an assessment-driven, individually tailored package of interventions delivered over the course of 4 months by an occupational therapist (OT) (~6 home visits for ≤ 1hour), a registered nurse (RN) (~4 home visits for ≤ 1hour) and a handy worker (HW). Refinements based on the open label pilot results will be included.
| Study group | Role | What they receive |
|---|---|---|
| Open Label Pilot | Experimental | The Open Label Pilot (Phase 4) will include testing the CAPABLE Family intervention with 6 individuals with MCI or early-stage dementia. At least 5 of the 6 older adults will be required to have a family member involved. Assuming all have a family member involved (though one may not), 12 participants will be enrolled in the open label pilot.
Open label pilot participants will be asked to provide feedback halfway through the intervention and at the end via phone conversations with the research study team, allowing the study team to make changes accordingly. Receives: Behavioral: CAPABLE Family - Open Label Pilot |
| Randomized Control Pilot - Intervention Arm | Experimental | After the open label pilot, 17 older adults (and if available, care partners) will be randomized to the CAPABLE Family intervention. They will be assessed at baseline, after the 4 month intervention, and after the waitlist control arm. Receives: Behavioral: CAPABLE Family - Randomized Control Trial |
| Randomized Control Pilot - Waitlist Control Arm | Active comparator | The waitlist control group, 17 older adults and if available, care partners, will receive the intervention after they have served as controls to the immediate treatment group, ensuring all participants have access to the intervention. Receives: Behavioral: CAPABLE Family - Randomized Control Trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living
6 questions, each 1 point for a total score of 6. A score closer to 6 indicates high patient independence.
Measured: Baseline, 16 weeks, 32 weeks
Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale
The assessment contains 8 questions with answers that are either a score of 0 or 1. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias.
Measured: Baseline, 16 weeks, 32 weeks
Change in Pain as assessed by the Brief Pain Inventory (Short Form)
The Brief Pain Inventory - Short Form is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. For the 10 point scale, 0 indicated no pain and 10 indicates the worst imaginable pain.
Measured: Baseline, 16 weeks, 32 weeks
Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8)
The PHQ-8 contains 8 questions, with a 0-3 scale. A score of 10 or greater is considered major depression, 20 or more is severe major depression.
Measured: Baseline, 16 weeks, 32 weeks
Change in caregiving burden as assessed by the Perceived Change Index Scale
The Perceived Change Index Scale contains13 questions related to change in caregiver self-improvement wellbeing. Each rated on a scale of 1-5, 1 indicating much worse, 5 indicating improved a lot. The higher the overall score, the greater the improvement.
Measured: 16 weeks, 32 weeks
Change in Perceived Change in Function Scale Score
14 questions related to perceived improvement in function. Scale of -2 (gotten much worse) to 2 (improved a lot). The higher the overall score, the greater the improvement.
Measured: 16 weeks, 32 weeks
Satisfaction at midpoint of intervention assessed by qualitative questions
Older Adult and Care Partner Satisfaction at midpoint of intervention assessed by qualitative questions. Qualitative questions will help us understand how best to tailor the intervention for the randomized control pilot.
Measured: 8 weeks
Satisfaction at endpoint of intervention as assessed by qualitative questions
Older Adult and Care Partner Satisfaction at endpoint of intervention assessed by qualitative questions. Qualitative questions will help us understand how best to tailor the intervention for the randomized control pilot.
Measured: 16 weeks
Level of Cognitive Impairment for eligibility as assessed by the Montreal Cognitive Assessment (MoCA) Blind/Telephone
Scoring for the Blind/Telephone assessment is out of 22. Score of 12-17 indicates Mild Cognitive Impairment/Early Stage Dementia and is the eligibility requirement for participation in the study.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start9 Mar 2022
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dementia, MildStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Waitlist Control Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research, Rita & Alex Hillman Foundation
- Responsible party
- Sponsor
- Investigators
- Sarah Szanton, PhD, RN, Principal investigator, Johns Hopkins School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187117
- Sponsor's protocol ID
- IRB00290674
- Status last verified
- Apr 2024
- First submitted
- 22 Dec 2021
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Szanton SL, Wolff JW, Leff B, Thorpe RJ, Tanner EK, Boyd C, Xue Q, Guralnik J, Bishai D, Gitlin LN. CAPABLE trial: a randomized controlled trial of nurse, occupational therapist and handyman to reduce disability among older adults: rationale and design. Contemp Clin Trials. 2014 May;38(1):102-12. doi: 10.1016/j.cct.2014.03.005. Epub 2014 Mar 28.
PubMed 24685996
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAPABLE Family Pilot
- ClinicalTrials.gov ID
- NCT05187117
- Acronym / sponsor ID
- IRB00290674
- Conditions
- Dementia, Mild, Mild Cognitive Impairment, Disability Physical, Impairment, Cognitive, Caregiver Burden, Quality of Life
- Keywords
- Activities of Daily Living, Instrumental Activities of Daily Living, Caregiving, Physical Function, Executive Function, Home, Intervention, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research, Rita & Alex Hillman Foundation
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 11 Jan 2022 (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 purpose of this study is to test the adapted protocol, CAPABLE Family which builds upon the evidenced based CAPABLE program to address older adults with co-occurring physical disability and mild cognitive impairment or early stage dementia and the older adults' caregivers. It will consist of two phases - an open label pilot and waitlist control trial.
Detailed description
CAPABLE (NA_00031539) is an evidence-based program that reduces physical disability, but was designed for people who are cognitively intact.
The investigators seek to adapt CAPABLE to meet the needs of older adults with physical disability and mild cognitive impairment and early stage dementia. The investigators also seek to meet the needs of family members who serve as informal caregivers in relation to the physical function of those with cognitive impairment. The purpose of this pilot study is to test a new protocol for a new program, CAPABLE Family, to address older adults with co-occurring physical disability and dementia and the older adults' caregivers.
CAPABLE is a multicomponent goal-directed program that reduces physical disability by working with the person and environment, but was designed for people who are cognitively intact. Based on the Centers for Medicare and Medicaid (CMS) request, the investigators' team briefly included people with mild dementia in the regular CAPABLE protocol. Looking back on that preliminary data, the investigators identified a subset of 12 older adults with mild dementia with Mini-Mental State Examination (MMSE) scores of 23 or below. The investigators found that more than half improved in Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) which is promising but much lower than CAPABLE the rest of the cohorts which suggests the need to adapt CAPABLE for people with dementia. Therefore, the investigators have adapted CAPABLE for people with mild cognitive impairment or early stage dementia calling it CAPABLE Family.
As in CAPABLE (NA_00031539), the delivery characteristics of CAPABLE Family consist of an assessment-driven, individually tailored package of interventions delivered over the course of 4 months by an occupational therapist (OT) (~6 home visits for ≤ 1hour), a registered nurse (RN) (~4 home visits for ≤ 1hour) and a handy worker (HW).
This research study is a continuation of IRB00243117 during which the investigators conducted preliminary activities to design the CAPABLE Family intervention. This study will include two phases, an open label pilot and a randomized control trial. The investigators will collect feedback during the open label pilot from the study team clinicians, older adult participants and care partners to further refine the intervention that will be tested as part of the randomized control trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Waitlist Control Trial
| Arm | Type | Receives |
|---|---|---|
| Open Label Pilot | Experimental | Behavioral: CAPABLE Family - Open Label PilotThe Open Label Pilot (Phase 4) will include testing the CAPABLE Family intervention with 6 individuals with MCI or early-stage dementia. At least 5 of the 6 older adults will be required to have a family member involved. Assuming all have a family member involved (though one may not), 12 participants will be enrolled in the open label pilot. Open label pilot participants will be asked to provide feedback halfway through the intervention and at the end via phone conversations with the research study team, allowing the study team to make changes accordingly. |
| Randomized Control Pilot - Intervention Arm | Experimental | Behavioral: CAPABLE Family - Randomized Control TrialAfter the open label pilot, 17 older adults (and if available, care partners) will be randomized to the CAPABLE Family intervention. They will be assessed at baseline, after the 4 month intervention, and after the waitlist control arm. |
| Randomized Control Pilot - Waitlist Control Arm | Active comparator | Behavioral: CAPABLE Family - Randomized Control TrialThe waitlist control group, 17 older adults and if available, care partners, will receive the intervention after they have served as controls to the immediate treatment group, ensuring all participants have access to the intervention. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have at least 1 ADL disability
- Have mild cognitive impairment or mild dementia (as indicated by clinician diagnosis, subjective cognitive complaints, or Blind/Telephone Montreal Cognitive Assessment (MoCA)(score of 16-23)
- Care partners will be included if they provide >10 hours of care/week
- Live in Baltimore City/County
Key exclusion criteria (1 listed)
- Live in long term care setting
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 |
|---|---|---|
| CAPABLE Family - Open Label PilotAs in CAPABLE (NA_00031539), the delivery characteristics of CAPABLE Family consist of an assessment-driven, individually tailored package of interventions delivered over the course of 4 months by an occupational therapist (OT) (~6 home visits for ≤ 1hour), a registered nurse (RN) (~4 home visits for ≤ 1hour) and a handy worker (HW). Adaptations for cognitive decline will be made on a per-client basis as part of the open-label pilot. Topics of adaptations include problem areas addresses, care partner involvement, length/frequency of visits, types of assessments and questions asked, and brainstorming/action planning structure. | Behavioural | Open Label Pilot |
| CAPABLE Family - Randomized Control TrialAs in CAPABLE (NA_00031539), the delivery characteristics of CAPABLE Family consist of an assessment-driven, individually tailored package of interventions delivered over the course of 4 months by an occupational therapist (OT) (~6 home visits for ≤ 1hour), a registered nurse (RN) (~4 home visits for ≤ 1hour) and a handy worker (HW). Refinements based on the open label pilot results will be included. | Behavioural | Randomized Control Pilot - Intervention Arm, Randomized Control Pilot - Waitlist Control Arm |
Primary outcome
Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living
Time frame: Baseline, 16 weeks, 32 weeks
6 questions, each 1 point for a total score of 6. A score closer to 6 indicates high patient independence.
Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale
Time frame: Baseline, 16 weeks, 32 weeks
The assessment contains 8 questions with answers that are either a score of 0 or 1. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias.
Change in Pain as assessed by the Brief Pain Inventory (Short Form)
Time frame: Baseline, 16 weeks, 32 weeks
The Brief Pain Inventory - Short Form is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. For the 10 point scale, 0 indicated no pain and 10 indicates the worst imaginable pain.
Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8)
Time frame: Baseline, 16 weeks, 32 weeks
The PHQ-8 contains 8 questions, with a 0-3 scale. A score of 10 or greater is considered major depression, 20 or more is severe major depression.
Change in caregiving burden as assessed by the Perceived Change Index Scale
Time frame: 16 weeks, 32 weeks
The Perceived Change Index Scale contains13 questions related to change in caregiver self-improvement wellbeing. Each rated on a scale of 1-5, 1 indicating much worse, 5 indicating improved a lot. The higher the overall score, the greater the improvement.
Change in Perceived Change in Function Scale Score
Time frame: 16 weeks, 32 weeks
14 questions related to perceived improvement in function. Scale of -2 (gotten much worse) to 2 (improved a lot). The higher the overall score, the greater the improvement.
Satisfaction at midpoint of intervention assessed by qualitative questions
Time frame: 8 weeks
Older Adult and Care Partner Satisfaction at midpoint of intervention assessed by qualitative questions. Qualitative questions will help us understand how best to tailor the intervention for the randomized control pilot.
Satisfaction at endpoint of intervention as assessed by qualitative questions
Time frame: 16 weeks
Older Adult and Care Partner Satisfaction at endpoint of intervention assessed by qualitative questions. Qualitative questions will help us understand how best to tailor the intervention for the randomized control pilot.
Level of Cognitive Impairment for eligibility as assessed by the Montreal Cognitive Assessment (MoCA) Blind/Telephone
Time frame: Baseline
Scoring for the Blind/Telephone assessment is out of 22. Score of 12-17 indicates Mild Cognitive Impairment/Early Stage Dementia and is the eligibility requirement for participation in the study.
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 17 Apr 2024.
- Background: PubMed 24685996Szanton SL, Wolff JW, Leff B, Thorpe RJ, Tanner EK, Boyd C, Xue Q, Guralnik J, Bishai D, Gitlin LN. CAPABLE trial: a randomized controlled trial of nurse, occupational therapist and handyman to reduce disability among older adults: rationale and design. Contemp Clin Trials. 2014 May;38(1):102-12. doi: 10.1016/j.cct.2014.03.005. Epub 2014 Mar 28.
- Individual participant dataSharing planned: No
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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.
Sarah Szanton, PhD, RN principal investigator
Johns Hopkins School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAPABLE Family - Open Label Pilot in people with Dementia, Mild and Mild Cognitive Impairment, run by Johns Hopkins University 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 4 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 17 Apr 2024. 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?
Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living (time frame: Baseline, 16 weeks, 32 weeks). The study lists 9 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 NCT05187117, which also lists 1 linked publication.
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 17 Apr 2024.