CAPABLE Care + Connect for Loneliness and Social Isolation

Overseen By Samantha Curriero, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Terminally ill, Long term care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 16 weeks

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a program called CAPABLE Care + Connect can assist individuals who feel lonely or isolated, particularly those with disabilities requiring home-based care. CAPABLE has improved quality of life, and this study will evaluate its effectiveness alongside another similar care program. The trial includes different groups: some participants will use CAPABLE with a caregiver, some without, and others will continue their usual care for comparison. Individuals living in Baltimore County or City, experiencing difficulties with daily activities, and feeling socially isolated may be suitable candidates if they are not undergoing active cancer treatment. As an unphased trial, this study provides a unique opportunity to explore innovative care approaches that could enhance quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the CAPABLE Care + Connect program is safe for individuals experiencing social isolation and/or loneliness?

Studies have shown that participants find the CAPABLE program easy to handle. Research indicates that CAPABLE improves strength, balance, and mobility in older adults. It also reduces hospital stays and nursing home visits. More than ten years of research support its safety and effectiveness in enhancing the quality of life for older adults.

The treatment does not involve medication or surgery, which usually results in fewer side effects. Instead, it includes home modifications and support to solve problems and achieve personal goals. So far, no major negative effects have been reported in connection with CAPABLE, making it a safe option for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CAPABLE Care + Connect intervention because it offers a holistic approach to tackling loneliness and social isolation, especially among older adults. Unlike standard care which often focuses on direct medical treatment, CAPABLE combines practical home-based assistance with social connection strategies, aiming to improve both physical and emotional well-being. This intervention is unique as it involves both caregiver-patient dyads and older adults without caregivers, tailoring support to individual needs and potentially enhancing the quality of life more effectively than typical one-size-fits-all solutions. By integrating social interaction with care, CAPABLE could redefine how we support isolated individuals, offering new hope for those who feel left out by conventional methods.

What evidence suggests that the CAPABLE Care + Connect intervention could be effective for reducing loneliness and social isolation?

Research has shown that the CAPABLE program helps older adults improve self-care. In a past study, 75% of low-income older adults who participated in CAPABLE enhanced their self-care abilities. The program also increased their independence in daily activities and improved their health. In this trial, the CAPABLE Care + Connect treatment aims to reduce loneliness and social isolation, building on these successes. Although specific data on its effectiveness for social isolation is limited, the program's past success in enhancing quality of life suggests it could be beneficial. ^{2 3 5 6 7}

Who Is on the Research Team?

Thomas Cudjoe, MD, MPH, MA

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for individuals over 50 who are part of the JHOME program, feel socially isolated or lonely, can speak English, and have some difficulty with daily activities. They should be cognitively intact (with a MOCA score >23) and able to attend a virtual or in-person meeting lasting up to an hour. Those frequently hospitalized or under 50 cannot participate.

Inclusion Criteria

I struggle with daily activities like dressing or bathing.

My mental functions are normal.

I am currently enrolled in the JHOME program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the CAPABLE intervention, which includes home visits by an occupational therapist, registered nurse, and handy worker over 4 months

16 weeks

6 home visits by OT, 4 home visits by RN

Follow-up

Participants are monitored for changes in function, pain, depression, social connection, and caregiver burden

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CAPABLE Care + Connect

Trial Overview The CAPABLE Care + Connect pilot is testing whether combining two home-based care programs can improve quality of life for people living with disabilities and their caregivers by reducing social isolation and loneliness.

How Is the Trial Designed?

Group I: Pilot- Intervention Experimental Treatment 1 Intervention

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

Group II: Open-Label Pilot Experimental Treatment 1 Intervention

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.

Group III: Standard of Care Group Active Control 1 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 Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

The Rita and Alex Hillman Foundation

Collaborator

Trials

2

Recruited

230+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07123298

Study Details | NCT07123298 | CAPABLE Care + Connect Amid limited to no evidence-based strategies to address social isolation and loneliness, this study offers a unique opportunity to address this problem. Because ...

2. withpower.com withpower.com/trial/phase-social-isolation-8-2025-a7767

CAPABLE Care + Connect for Loneliness and Social ... This N/A medical study run by Johns Hopkins University is evaluating whether CAPABLE Care + Connect will have tolerable side effects & efficacy for patients ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11689804/

ADAPTING THE CAPABLE PROGRAM TO ADDRESS ... The overarching goal of CAPABLE Care + Connect is to better address the needs of homebound older adults experiencing limited life space and limited social ...

4. nursing.jhu.edu nursing.jhu.edu/faculty-research/research/projects/capable/

Community Aging in Place—Advancing Better Living for ... In a population of low-income older adults on Medicaid and Medicare who participated in CAPABLE, 75% of participants improved their self-care over the course of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9908520/

Implementation of the CAPABLE Program With Older ... This program evaluation study identified improvement in IADL independence, readiness to change, self-reported health status, and self-reported ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07123298

Study Details | NCT07123298 | CAPABLE Care + Connect 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 ...

7. brothersredevelopment.org brothersredevelopment.org/wp-content/uploads/2024/04/11.-CAPABLE-3-Page-Overview-1.pdf

CAPABLE promotes older adults' ability to age in their ... Studies showed reduced hospitalization and nursing home stays by improving medication management, problem-solving ability, strength, balance, mobility, ...