AgingNCT05670639
CAPABLE Care Partner Pilot Study
A study testing CAPABLE Care Partner in people with Aging and Caregiver Burden, run by Johns Hopkins University at 1 site in United States.
Trial summary
This is a small-scale multi-site pilot of a supplemental enhancement called "Care Partner" to the evidence-based CAPABLE program that will involve up to 60 individuals (30 care partners and older adult dyads) and 30 professional staff in organizations currently licensed to provide CAPABLE. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Caregiver Burden
- What is being tested?
- CAPABLE Care Partner
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2023to 2 Jan 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Care Partner:
- Provides 10+ hours/week of care or support for CAPABLE program participant
- Able to participate in two 45 minutes phone interview or virtual meetings
- English-speaking
- CAPABLE Participant:
- CAPABLE participant of one of the CAPABLE programs offered by a pilot site organization
Show all 21Show fewer
- Able to participate in two 30-minute phone interview or virtual meetings
- English-speaking
- Occupational Therapist (OT)/ Registered Nurse (RN):
- Has been trained to provide CAPABLE and has served CAPABLE clients for at least 6 months
- Currently serving CAPABLE participants
- Able to participate in two one-hour phone call or virtual meetings
- English-speaking
- Care Partner Support Specialist
- Licensed social worker or other professional trained in providing caregiver support
- Able to participate in two one-hour phone call or virtual meetings
- English-speaking
- Program Administrator
- Currently managing a CAPABLE program
- Able to participate in two one-hour phone call or virtual meetings
- English-speaking
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Nursing
Baltimore, Maryland, 21205
About this study
This is a small-scale multi-site pilot of a supplemental enhancement called "Care Partner" to the evidence-based CAPABLE program that will involve up to 60 individuals (30 care partners and older adult dyads) and 30 professional staff in organizations currently licensed to provide CAPABLE. This is a qualitative study of a convenience sample of individuals.
Read the detailed description
Care partners (family/friend caregivers) of older adults are integral to the ability of these individuals to remain living in the community as independently as possible. Through the 12-year history of developing and offering CAPABLE, particularly the last four years when the program has been nationally disseminated, CAPABLE sites across the country have observed that in about 25% of cases, the older adult participant has a family or friend care partner who either lives with the older person (usually a spouse/partner) or is significantly involved in providing care or support with activities of daily living. This is consistent with other research on the level of caregiving in the U.S which indicates from 21-25% of individuals in the U.S. provided care to a family member or friend with a health limitation or disability within the last 30 days.
The evidence-based CAPABLE program developed by Drs. Gitlin and Szanton of Johns Hopkins School of Nursing does not currently have a structured or consistent way to involve these care partners in CAPABLE, nor does it offer any support to the care partner directly. Research on caregivers indicates that from 20-50% report delaying or skipping care as a result of focusing on caregiving for others and that caregiving has negatively impacted the caregivers own health status. However, there are positive aspects of caregiving as well, including deepening the relationship and enhancing the sense of purpose for the caregiver. The Centers for Disease Control and Prevention have identified need for support to caregivers in the Public Health Call to Action.
In Phases 1 and 2 of this CAPABLE Care Partner study (completed), the investigators co-created the Care Partner component as an add-on to CAPABLE, working with caregiving experts, CAPABLE clinicians, older adults, and care partners.
The purpose of this Care Partner Pilot Study is to:
- develop a prototype for an enhanced component to CAPABLE, focusing on the family or friend caregiver (called Care Partner) and
- evaluate the prototype through a multi-site pilot so it can be used by existing sites.
This pilot focuses on feasibility and acceptability of the Care Partner component, and a preliminary assessment of the effect on care partners.
The objectives are:
- Assess the feasibility of the CAPABLE Care Partner component being integrated into CAPABLE from the perspective of CAPABLE participants, care partners, CAPABLE program administrators, CAPABLE clinicians, and the Care Partner Support Specialist
- Determine the acceptability of CAPABLE Care Partner component to CAPABLE participants, care partners, CAPABLE program administrators, CAPABLE clinicians, and the Care Partner Support Specialist
- Evaluate effect of the Care Partner component on care partners, measuring self-reported competency, well-being, and indicators of stress, and obtaining qualitative information from a convenience sample of care partners.
- Conditions
- Aging, Caregiver Burden
- Being tested
- CAPABLE Care Partner
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPABLE Care PartnerBehavioural
The CAPABLE Care Partner intervention consists of three components: 1) up to 3 sessions with a Care Partner Support person focused on developing action plans for self-care goals of the care partner 2) educational materials provided in a folder at the beginning of the program 3) inclusion in the CAPABLE clinician visits as deemed appropriate by the client, CAPABLE clinicians, and care partner
| Study group | Role | What they receive |
|---|---|---|
| Pilot | Other | Not described Receives: Behavioral: CAPABLE Care Partner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of acceptance of intervention as assessed by qualitative assessments
Qualitative interviews with each type of key informant at the end of the pilot will help us understand the level of acceptance of the Care Partner addition by each subject type (i.e., care partner, clinician, administrator). An adjectival scale will be used with 4 points from "Very satisfied to Very unsatisfied" together with open-ended questions.
Measured: 10-12 months
Potential barriers and catalysts in implementation as assessed by key informant interviews with program administrators via semi-structured interview guide
Potential barriers and catalysts in implementation for incorporating Care Partners into CAPABLE-including the feasibility related to costs, resources, and other factors through key informant interviews with the program administrators using a semi-structured interview guide. An Adjectival scale will be used with 4 points from "Very satisfied to Very unsatisfied" together with open-ended questions.
Measured: 10 months
Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-2)
The PHQ-2 screening instrument contains 2 questions, 4-point Adjectival Likert scale from "Not at all" to "Nearly every day" with the "nearly every day" response indicating more severe depressive symptoms.
Measured: Baseline, 4 months - at the end of the intervention for each care partner
Change in self-reported health status as assessed by one item in the 12-item Short Form Survey (SF-12)
The SF-12 is a 12-item questionnaire with a 5-point Likert scale (responses ranging from 'excellent' to 'poor'). The self-report of "fair" or "poor" indicates worse self-reported health status and has shown predictive power associated with higher morbidity or mortality.
Measured: Baseline, 4 months at the completion of the intervention for each care partner
Change in the perception of caregiving effectiveness as measured by the Caregiving Effectiveness Scale (Noelker)
Two items from the Caregiving Effectiveness scale with a 4-point adjectival Likert scale (responses ranging from 'very satisfied' to 'not satisfied at all'. A response of "not satisfied at all" indicates lower perception of caregiving effectiveness.
Measured: Baseline, 4 months at the completion of the intervention for each care partner
Change in caregiving competence and confidence as assessed by the Pearlin's Caregiving Competence Scale.
Two items using a 5-point adjectival Likert scale (responses ranging from "Strongly disagree to Strongly Agree). A higher score (agreement) would indicate higher competency/satisfaction.
Measured: Baseline, 4 months at completion of the intervention for each care partner
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start10 Jan 2023
- Primary completion2 Jan 2024
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670639
- Sponsor's protocol ID
- IRB00308713
- Status last verified
- Feb 2024
- First submitted
- 13 Dec 2022
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAPABLE Care Partner Pilot Study
- ClinicalTrials.gov ID
- NCT05670639
- Acronym / sponsor ID
- IRB00308713
- Conditions
- Aging, Caregiver Burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 4 Jan 2023 (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.
This is a small-scale multi-site pilot of a supplemental enhancement called "Care Partner" to the evidence-based CAPABLE program that will involve up to 60 individuals (30 care partners and older adult dyads) and 30 professional staff in organizations currently licensed to provide CAPABLE. This is a qualitative study of a convenience sample of individuals.
Detailed description
Care partners (family/friend caregivers) of older adults are integral to the ability of these individuals to remain living in the community as independently as possible. Through the 12-year history of developing and offering CAPABLE, particularly the last four years when the program has been nationally disseminated, CAPABLE sites across the country have observed that in about 25% of cases, the older adult participant has a family or friend care partner who either lives with the older person (usually a spouse/partner) or is significantly involved in providing care or support with activities of daily living. This is consistent with other research on the level of caregiving in the U.S which indicates from 21-25% of individuals in the U.S. provided care to a family member or friend with a health limitation or disability within the last 30 days.
The evidence-based CAPABLE program developed by Drs. Gitlin and Szanton of Johns Hopkins School of Nursing does not currently have a structured or consistent way to involve these care partners in CAPABLE, nor does it offer any support to the care partner directly. Research on caregivers indicates that from 20-50% report delaying or skipping care as a result of focusing on caregiving for others and that caregiving has negatively impacted the caregivers own health status. However, there are positive aspects of caregiving as well, including deepening the relationship and enhancing the sense of purpose for the caregiver. The Centers for Disease Control and Prevention have identified need for support to caregivers in the Public Health Call to Action.
In Phases 1 and 2 of this CAPABLE Care Partner study (completed), the investigators co-created the Care Partner component as an add-on to CAPABLE, working with caregiving experts, CAPABLE clinicians, older adults, and care partners.
The purpose of this Care Partner Pilot Study is to:
- develop a prototype for an enhanced component to CAPABLE, focusing on the family or friend caregiver (called Care Partner) and
- evaluate the prototype through a multi-site pilot so it can be used by existing sites.
This pilot focuses on feasibility and acceptability of the Care Partner component, and a preliminary assessment of the effect on care partners.
The objectives are:
- Assess the feasibility of the CAPABLE Care Partner component being integrated into CAPABLE from the perspective of CAPABLE participants, care partners, CAPABLE program administrators, CAPABLE clinicians, and the Care Partner Support Specialist
- Determine the acceptability of CAPABLE Care Partner component to CAPABLE participants, care partners, CAPABLE program administrators, CAPABLE clinicians, and the Care Partner Support Specialist
- Evaluate effect of the Care Partner component on care partners, measuring self-reported competency, well-being, and indicators of stress, and obtaining qualitative information from a convenience sample of care partners.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot | Other | Behavioral: CAPABLE Care Partner |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Provides 10+ hours/week of care or support for CAPABLE program participant
- Able to participate in two 45 minutes phone interview or virtual meetings
- English-speaking
- CAPABLE participant of one of the CAPABLE programs offered by a pilot site organization
- Able to participate in two 30-minute phone interview or virtual meetings
Key exclusion criteria (0 listed)
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 Care PartnerThe CAPABLE Care Partner intervention consists of three components: 1) up to 3 sessions with a Care Partner Support person focused on developing action plans for self-care goals of the care partner 2) educational materials provided in a folder at the beginning of the program 3) inclusion in the CAPABLE clinician visits as deemed appropriate by the client, CAPABLE clinicians, and care partner | Behavioural | Pilot |
Primary outcome
Level of acceptance of intervention as assessed by qualitative assessments
Time frame: 10-12 months
Qualitative interviews with each type of key informant at the end of the pilot will help us understand the level of acceptance of the Care Partner addition by each subject type (i.e., care partner, clinician, administrator). An adjectival scale will be used with 4 points from "Very satisfied to Very unsatisfied" together with open-ended questions.
Potential barriers and catalysts in implementation as assessed by key informant interviews with program administrators via semi-structured interview guide
Time frame: 10 months
Potential barriers and catalysts in implementation for incorporating Care Partners into CAPABLE-including the feasibility related to costs, resources, and other factors through key informant interviews with the program administrators using a semi-structured interview guide. An Adjectival scale will be used with 4 points from "Very satisfied to Very unsatisfied" together with open-ended questions.
Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-2)
Time frame: Baseline, 4 months - at the end of the intervention for each care partner
The PHQ-2 screening instrument contains 2 questions, 4-point Adjectival Likert scale from "Not at all" to "Nearly every day" with the "nearly every day" response indicating more severe depressive symptoms.
Change in self-reported health status as assessed by one item in the 12-item Short Form Survey (SF-12)
Time frame: Baseline, 4 months at the completion of the intervention for each care partner
The SF-12 is a 12-item questionnaire with a 5-point Likert scale (responses ranging from 'excellent' to 'poor'). The self-report of "fair" or "poor" indicates worse self-reported health status and has shown predictive power associated with higher morbidity or mortality.
Change in the perception of caregiving effectiveness as measured by the Caregiving Effectiveness Scale (Noelker)
Time frame: Baseline, 4 months at the completion of the intervention for each care partner
Two items from the Caregiving Effectiveness scale with a 4-point adjectival Likert scale (responses ranging from 'very satisfied' to 'not satisfied at all'. A response of "not satisfied at all" indicates lower perception of caregiving effectiveness.
Change in caregiving competence and confidence as assessed by the Pearlin's Caregiving Competence Scale.
Time frame: Baseline, 4 months at completion of the intervention for each care partner
Two items using a 5-point adjectival Likert scale (responses ranging from "Strongly disagree to Strongly Agree). A higher score (agreement) would indicate higher competency/satisfaction.
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 12 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
RecruitingPhase 4
PLLA and CaHA-R for Aesthetic Rejuvenation
Aesthetic
RecruitingObservational study
Genetic and Epigenetic Signatures of Translational Aging Laboratory Testing (GESTALT)
Healthy Volunteers, Non-Healthy/Non-Frail
Recruiting
Exercise for an Aging Liver (EXALIVER)
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, MASH - Metabolic Dysfunction-Associated Steatohepatitis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Care Partner in people with Aging and Caregiver Burden, 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 21 inclusion and 0 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 12 Feb 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?
Level of acceptance of intervention as assessed by qualitative assessments (time frame: 10-12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2024.