Social Isolation in Older AdultsNCT07123298
CAPABLE Care + Connect
A study testing CAPABLE Care + Connect - Open Label Pilot and CAPABLE Care + Connect - Pilot in people with Social Isolation in Older Adults and Social Isolation or Loneliness, run by Johns Hopkins University at 1 site in United States.
Trial summary
In this evaluation scale-up research project, the investigators seek to test an implementation of CAPABLE on the infrastructure of home-based primary care for individuals who may experience social isolation and/or loneliness. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Isolation in Older Adults, Social Isolation or Loneliness, Social Isolation
- What is being tested?
- CAPABLE Care + Connect - Open Label Pilot and CAPABLE Care + Connect - Pilot
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2025to May 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any patient currently in JHOME
- At risk for or experiencing social isolation as defined by the Lubben Social Network Scale 6 item score less than or equal 12 points or loneliness as defined by the UCLA Loneliness Scale 3 item score of 6 to 9 points
- Cognitive inclusion criteria Montreal Cognitive Assessment (MOCA) >23 as determined by referring JHOME study team member provider
- English speaking (measures are standardized in English)
- Ability to participate in an approximately 45-60 min virtual or in person meeting
- Eligible for CAPABLE
Show all 13Show fewer
- 50 years or older
- Not hospitalized over night more than 4 times in the last 12 months
- Have some difficulty with any ADL
- Cognitively intact
- Live in Baltimore County or Baltimore City
- Not receiving active cancer treatment
- Interested in participating in CAPABLE Care partners will be included if the care partners provide > 10 hours of care/week
Who cannot join
- Terminally ill
- live in long term care setting
- receiving active cancer treatment
- Standard of Care/Comparison group Inclusion Criteria:
- Any patient currently in JHOME who did not receive the CAPABLE intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins School of Nursing
Baltimore, Maryland, 21205
About this study
Official title: CAPABLE Care + Connect: Pilot Feasibility of Implementing CAPABLE Into Homebased Primary Care
In this evaluation scale-up research project, the investigators seek to test an implementation of CAPABLE on the infrastructure of home-based primary care for individuals who may experience social isolation and/or loneliness. These two home-based care programs may improve each other and provide opportunity to further improve quality of life for people living with disabilities and the caregivers. The purpose of this mixed methods study is to adapt and test CAPABLE, an existing evidence-based program, to a new target population with the scalable infrastructure of home-based primary care.
Read the detailed description
CAPABLE is a home-based, interdisciplinary, goal-directed program that reduces physical disability by working with the person and environment. This program has shown improved performance of activities of daily living (ADL), instrumental activities of daily living (IADL), and depression. Coordinating CAPABLE and Johns Hopkins Home-Based Medicine (JHOME) can help address barriers to health, function, and social connection. Amid limited to no evidence-based strategies to address social isolation and loneliness, this study offers a unique opportunity to address this problem. Because CAPABLE addresses environmental and personal needs to improve the ADL and IADL function of people with disabilities, combining the two programs may better enable people who are homebound to more easily navigate and access the home or beyond. Additionally, this effort will enable the investigators to explore the impact of this combined intervention on social isolation and loneliness.
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).
The purpose of this mixed methods study is to adapt and test CAPABLE, an existing evidence-based program, to a new target population with the scalable infrastructure of home-based primary care. The investigators seek to explore if the CAPABLE program increases social connection in homebound older adults, and if the benefits of CAPABLE services improve social connections among socially isolated/lonely homebound older adults.
- Conditions
- Social Isolation in Older Adults, Social Isolation or Loneliness, Social Isolation, Quality of Life, Disability Physical, Homebound Persons
- Being tested
- CAPABLE Care + Connect - Open Label Pilot, CAPABLE Care + Connect - Pilot
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPABLE Care + Connect - Open Label PilotBehavioural
As in CAPABLE, the delivery characteristics of CAPABLE Care + Connect 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 targeting those in JHOME will be made on a per-client basis as part of the open-label pilot. The investigators will further refine and develop the intervention by receiving feedback from the open label pilot participants and CAPABLE clinicians who implemented the pilot to gain those perspectives of the acceptability and feasibility of implementing the CAPABLE Care + Connect intervention. Based on this feedback, the study team will have developed an adapted iteration of the prototype.
CAPABLE Care + Connect - PilotBehavioural
As in CAPABLE, the delivery characteristics of CAPABLE Care + Connect 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 will include testing the CAPABLE Care + Connect intervention on a total of 8. The investigators will recruit and provide CAPABLE to four caregiver-patient dyads (eight participants) and four older adults without caregivers. Receives: Behavioral: CAPABLE Care + Connect - Open Label Pilot |
| Pilot- Intervention | Experimental | The investigators will recruit fifteen new partner-patient dyads and fifteen participants without caregivers to receive CAPABLE. That is a total of 45 participants that will receive the CAPABLE intervention Receives: Behavioral: CAPABLE Care + Connect - Pilot |
| Standard of Care Group | No intervention | The standard of care/comparison group will apply for JHOME patients. There are currently around 400-450 patients in JHOME, therefore, our total sample size including both intervention and standard of care group will be up to 450 people. It is important to note that the standard of care group is for individuals who did not complete the intervention and is used to evaluate the effectiveness of the intervention itself. Those eligible for the intervention will be included in the study, whereas those ineligible based on intervention screen will be asked about record review. If those ineligible decline record review, those ineligible will be excluded from entire study. |
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 Scale
6 questions, each 1 point for a total score range of 1- 6. A score closer to 6 indicates high patient independence, better outcome.
Measured: Baseline, 16 weeks
Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale (IADL)
Participants rate their ability to perform daily tasks on a 5-point scale (1 = no difficulty, 2 = a little difficulty, 3 = moderate difficulty, 4 = a lot of difficulty, 5 = unable to do). Score range 8 to 40, higher scores represent greater difficulty performing ADLs, worse outcome.
Measured: Baseline, 16 weeks
Change in Pain as assessed by the Brief Pain Inventory Scale (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. For the 10 point scale, 0 indicated no pain and 10 indicates the worst imaginable pain. Score range 0-90, higher score worse outcome.
Measured: Baseline, 16 weeks
Change in Function as assessed by the American Community Survey Disability Measure
This measure is used to identify whether a person is considered to have a disability based on responses to six standardized questions. A person is considered to have a disability if the person answers "Yes" to at least one of the six questions. There is no composite score.
Measured: Baseline, 16 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. Score range 0-24, higher score worse outcome.
Measured: Baseline, 16 weeks
Change in Social Connection as assessed by the Lubben Social Network Scale
The Lubben Social Network Scale - 12 item version (LSNS-12) includes 12 questions, each scored from 0 to 5 based on the number of social contacts, with total scores ranging from 0 to 60, where lower scores indicate greater social isolation, worse outcome.
Measured: Baseline, 16 weeks
Change in Social Connection as assessed by the University of California Los Angeles (UCLA) Loneliness Scale
The UCLA Loneliness Scale (20-item version) includes 20 questions, each rated on a 1 to 4 scale, with total scores ranging from 20 to 80, where higher scores indicate greater perceived loneliness, worse outcome.
Measured: Baseline, 16 weeks
Change in Social Connection as assessed by qualitative questions
2 open ended questions about social network. Qualitatively look at answers from descriptive perspective
Measured: Baseline, 16 weeks
Change in Caregiver Burden as assessed by Zarit Burden Inventory
The Zarit Burden Interview - 12 item version includes 12 questions, each scored from 0 (never) to 4 (nearly always), for a total score range of 0 to 48, with higher scores indicating greater caregiver burden, worse outcome.
Measured: Baseline, 16 weeks
Change in Perceived Change in Function Scale
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, better outcome.
Measured: 16 weeks
Change in Caregiver Burden as assessed by the Oberest Caregiver Burden Scale
The Oberst Caregiver Burden Scale includes 15 items rated on a 5-point scale assessing the time and difficulty of caregiving tasks, with total scores ranging from 15 to 75 per subscale and higher scores indicating greater burden.
Measured: Baseline, 16 weeks
Change in Caregiver Outcomes as assessed by the Bakas Caregiving Outcomes Scale
The Bakas Caregiving Outcomes Scale includes 15 items, each rated on a 7-point scale from -3 (changed for the worst) to +3 (changed for the best), with total scores reflecting the caregiver's perceived changes in life due to caregiving. Higher score better.
Measured: Baseline, 16 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 on a 10 point scale. 0 = no pain and 10 indicates the worst imaginable pain. Higher score worse outcome.
Measured: Baseline, 16 weeks
Change in Pain as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form
The PROMIS Pain Interference Short Form includes 6 questions, each rated on a 5-point scale, with raw scores summed and converted to a T-score, where higher scores indicate greater interference from pain in daily activities.
Measured: Baseline, 16 weeks
Secondary outcomes (4)
JHOME Health System Effects- Number Urgent Visits
Frequency (number) of urgent visits
Measured: 6 months prior to program, 16 weeks
JHOME Health System Effects- Number Emergency Room Visits
Frequency (number) of emergency room visits
Measured: 6 months prior to program, 16 weeks
JHOME Health System Effects - Nursing Home Placement
Yes/No to being placed in nursing home
Measured: 16 weeks
JHOME Health System Effects- Number of Medications
Number of medications prescribed
Measured: 6 months prior to program, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start14 Aug 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Isolation in Older AdultsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will have a standard of care group and an intervention group. The intervention group will receive the CAPABLE intervention, and the standard of care group is designed to look at long term outcomes of JHOME patients who did not enroll in CAPABLE compared to those who did.
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
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
- Thomas Cudjoe, MD, MPH, MA, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123298
- Sponsor's protocol ID
- IRB00471865
- Status last verified
- Jun 2026
- First submitted
- 7 Aug 2025
- Last updated
- 2 Jun 2026
- 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 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAPABLE Care + Connect: Pilot Feasibility of Implementing CAPABLE Into Homebased Primary Care
- ClinicalTrials.gov ID
- NCT07123298
- Acronym / sponsor ID
- IRB00471865
- Conditions
- Social Isolation in Older Adults, Social Isolation or Loneliness, Social Isolation, Quality of Life, Disability Physical, Homebound Persons
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research, Rita & Alex Hillman Foundation
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 14 Aug 2025 (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.
In this evaluation scale-up research project, the investigators seek to test an implementation of CAPABLE on the infrastructure of home-based primary care for individuals who may experience social isolation and/or loneliness. These two home-based care programs may improve each other and provide opportunity to further improve quality of life for people living with disabilities and the caregivers. The purpose of this mixed methods study is to adapt and test CAPABLE, an existing evidence-based program, to a new target population with the scalable infrastructure of home-based primary care.
Detailed description
CAPABLE is a home-based, interdisciplinary, goal-directed program that reduces physical disability by working with the person and environment. This program has shown improved performance of activities of daily living (ADL), instrumental activities of daily living (IADL), and depression. Coordinating CAPABLE and Johns Hopkins Home-Based Medicine (JHOME) can help address barriers to health, function, and social connection. Amid limited to no evidence-based strategies to address social isolation and loneliness, this study offers a unique opportunity to address this problem. Because CAPABLE addresses environmental and personal needs to improve the ADL and IADL function of people with disabilities, combining the two programs may better enable people who are homebound to more easily navigate and access the home or beyond. Additionally, this effort will enable the investigators to explore the impact of this combined intervention on social isolation and loneliness.
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).
The purpose of this mixed methods study is to adapt and test CAPABLE, an existing evidence-based program, to a new target population with the scalable infrastructure of home-based primary care. The investigators seek to explore if the CAPABLE program increases social connection in homebound older adults, and if the benefits of CAPABLE services improve social connections among socially isolated/lonely homebound older adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The investigators will have a standard of care group and an intervention group. The intervention group will receive the CAPABLE intervention, and the standard of care group is designed to look at long term outcomes of JHOME patients who did not enroll in CAPABLE compared to those who did.
| Arm | Type | Receives |
|---|---|---|
| Open-Label Pilot | Experimental | Behavioral: CAPABLE Care + Connect - Open Label PilotThe Open Label Pilot will include testing the CAPABLE Care + Connect intervention on a total of 8. The investigators will recruit and provide CAPABLE to four caregiver-patient dyads (eight participants) and four older adults without caregivers. |
| Pilot- Intervention | Experimental | Behavioral: CAPABLE Care + Connect - PilotThe investigators will recruit fifteen new partner-patient dyads and fifteen participants without caregivers to receive CAPABLE. That is a total of 45 participants that will receive the CAPABLE intervention |
| Standard of Care Group | No intervention | –The standard of care/comparison group will apply for JHOME patients. There are currently around 400-450 patients in JHOME, therefore, our total sample size including both intervention and standard of care group will be up to 450 people. It is important to note that the standard of care group is for individuals who did not complete the intervention and is used to evaluate the effectiveness of the intervention itself. Those eligible for the intervention will be included in the study, whereas those ineligible based on intervention screen will be asked about record review. If those ineligible decline record review, those ineligible will be excluded from entire study. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Any patient currently in JHOME
- At risk for or experiencing social isolation as defined by the Lubben Social Network Scale 6 item score less than or equal 12 points or loneliness as defined by the UCLA Loneliness Scale 3 item score of 6 to 9 points
- Cognitive inclusion criteria Montreal Cognitive Assessment (MOCA) >23 as determined by referring JHOME study team member provider
- English speaking (measures are standardized in English)
- Ability to participate in an approximately 45-60 min virtual or in person meeting
Key exclusion criteria (5 listed)
- Terminally ill
- live in long term care setting
- receiving active cancer treatment
- Any patient currently in JHOME who did not receive the CAPABLE intervention
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 + Connect - Open Label PilotAs in CAPABLE, the delivery characteristics of CAPABLE Care + Connect 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 targeting those in JHOME will be made on a per-client basis as part of the open-label pilot. The investigators will further refine and develop the intervention by receiving feedback from the open label pilot participants and CAPABLE clinicians who implemented the pilot to gain those perspectives of the acceptability and feasibility of implementing the CAPABLE Care + Connect intervention. Based on this feedback, the study team will have developed an adapted iteration of the prototype. | Behavioural | Open-Label Pilot |
| CAPABLE Care + Connect - PilotAs in CAPABLE, the delivery characteristics of CAPABLE Care + Connect 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 | Pilot- Intervention |
Primary outcome
Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living Scale
Time frame: Baseline, 16 weeks
6 questions, each 1 point for a total score range of 1- 6. A score closer to 6 indicates high patient independence, better outcome.
Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale (IADL)
Time frame: Baseline, 16 weeks
Participants rate their ability to perform daily tasks on a 5-point scale (1 = no difficulty, 2 = a little difficulty, 3 = moderate difficulty, 4 = a lot of difficulty, 5 = unable to do). Score range 8 to 40, higher scores represent greater difficulty performing ADLs, worse outcome.
Change in Pain as assessed by the Brief Pain Inventory Scale (Short Form)
Time frame: Baseline, 16 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. For the 10 point scale, 0 indicated no pain and 10 indicates the worst imaginable pain. Score range 0-90, higher score worse outcome.
Change in Function as assessed by the American Community Survey Disability Measure
Time frame: Baseline, 16 weeks
This measure is used to identify whether a person is considered to have a disability based on responses to six standardized questions. A person is considered to have a disability if the person answers "Yes" to at least one of the six questions. There is no composite score.
Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8)
Time frame: Baseline, 16 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. Score range 0-24, higher score worse outcome.
Change in Social Connection as assessed by the Lubben Social Network Scale
Time frame: Baseline, 16 weeks
The Lubben Social Network Scale - 12 item version (LSNS-12) includes 12 questions, each scored from 0 to 5 based on the number of social contacts, with total scores ranging from 0 to 60, where lower scores indicate greater social isolation, worse outcome.
Change in Social Connection as assessed by the University of California Los Angeles (UCLA) Loneliness Scale
Time frame: Baseline, 16 weeks
The UCLA Loneliness Scale (20-item version) includes 20 questions, each rated on a 1 to 4 scale, with total scores ranging from 20 to 80, where higher scores indicate greater perceived loneliness, worse outcome.
Change in Social Connection as assessed by qualitative questions
Time frame: Baseline, 16 weeks
2 open ended questions about social network. Qualitatively look at answers from descriptive perspective
Change in Caregiver Burden as assessed by Zarit Burden Inventory
Time frame: Baseline, 16 weeks
The Zarit Burden Interview - 12 item version includes 12 questions, each scored from 0 (never) to 4 (nearly always), for a total score range of 0 to 48, with higher scores indicating greater caregiver burden, worse outcome.
Change in Perceived Change in Function Scale
Time frame: 16 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, better outcome.
Change in Caregiver Burden as assessed by the Oberest Caregiver Burden Scale
Time frame: Baseline, 16 weeks
The Oberst Caregiver Burden Scale includes 15 items rated on a 5-point scale assessing the time and difficulty of caregiving tasks, with total scores ranging from 15 to 75 per subscale and higher scores indicating greater burden.
Change in Caregiver Outcomes as assessed by the Bakas Caregiving Outcomes Scale
Time frame: Baseline, 16 weeks
The Bakas Caregiving Outcomes Scale includes 15 items, each rated on a 7-point scale from -3 (changed for the worst) to +3 (changed for the best), with total scores reflecting the caregiver's perceived changes in life due to caregiving. Higher score better.
Change in Pain as assessed by the Brief Pain Inventory (Short Form)
Time frame: Baseline, 16 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 on a 10 point scale. 0 = no pain and 10 indicates the worst imaginable pain. Higher score worse outcome.
Change in Pain as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form
Time frame: Baseline, 16 weeks
The PROMIS Pain Interference Short Form includes 6 questions, each rated on a 5-point scale, with raw scores summed and converted to a T-score, where higher scores indicate greater interference from pain in daily activities.
4 secondary outcomes
JHOME Health System Effects- Number Urgent Visits
Time frame: 6 months prior to program, 16 weeks
JHOME Health System Effects- Number Emergency Room Visits
Time frame: 6 months prior to program, 16 weeks
JHOME Health System Effects - Nursing Home Placement
Time frame: 16 weeks
JHOME Health System Effects- Number of Medications
Time frame: 6 months prior to program, 16 weeks
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 2 Jun 2026.
- 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.
Thomas Cudjoe, MD, MPH, MA principal investigator
Johns Hopkins University
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 + Connect - Open Label Pilot and CAPABLE Care + Connect - Pilot in people with Social Isolation in Older Adults and Social Isolation or Loneliness, 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 13 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 2 Jun 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 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?
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 Chloe Wynn, MS (667-208-7444, cwynn3@jh.edu), or a site near the patient. 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 Scale (time frame: Baseline, 16 weeks). The study lists 14 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 2 Jun 2026.