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Behavioural Intervention

CAPABLE Family Adaptation for Dementia

N/A

Waitlist Available

Led By Sarah Szanton, PhD, RN

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have at least 1 ADL disability

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks, 32 weeks

Awards & highlights

Study Summary

This trial will test an adapted protocol, CAPABLE Family, which builds upon the CAPABLE program to address older adults with co-occurring physical disability and mild cognitive impairment or early stage dementia and their caregivers.

Who is the study for?

This trial is for older adults with mild cognitive impairment or early-stage dementia who have at least one disability in daily activities, and their caregivers providing more than 10 hours of care weekly. Participants must live in Baltimore City/County. Those living in long-term care settings cannot join.Check my eligibility

What is being tested?

The CAPABLE Family program is being tested to see if it helps older adults with physical disabilities and mild cognitive issues, along with their caregivers. The study has two parts: an initial phase where everyone gets the program (open label pilot) and a second phase comparing the program against a waitlist control group.See study design

What are the potential side effects?

Since this intervention involves non-medical adjustments to improve quality of life, traditional side effects like those seen with medications are not expected. However, participants may experience changes in mood or stress levels due to alterations in caregiving routines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I need help with at least one daily activity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8)

Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale

Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Randomized Control Pilot - Intervention ArmExperimental Treatment1 Intervention

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.

Group II: Open Label PilotExperimental Treatment1 Intervention

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.

Group III: Randomized Control Pilot - Waitlist Control ArmActive Control1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Disability, Independent Living, and Rehabilitation ResearchFED

71 Previous Clinical Trials

9,055 Total Patients Enrolled

1 Trials studying Depression

80 Patients Enrolled for Depression

The Rita and Alex Hillman FoundationUNKNOWN

1 Previous Clinical Trials

160 Total Patients Enrolled

Johns Hopkins UniversityLead Sponsor

2,259 Previous Clinical Trials

14,820,579 Total Patients Enrolled

57 Trials studying Depression

29,541 Patients Enrolled for Depression

Media Library

CAPABLE Family (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05187117 — N/A

Depression Research Study Groups: Randomized Control Pilot - Intervention Arm, Randomized Control Pilot - Waitlist Control Arm, Open Label Pilot

Depression Clinical Trial 2023: CAPABLE Family Highlights & Side Effects. Trial Name: NCT05187117 — N/A

CAPABLE Family (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05187117 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total enrollment size for this clinical investigation?

"Affirmative. Data on clinicaltrials.gov confirms that this research is still actively trying to find participants and began recruiting on March 9th 2022. The experiment seeks 80 patients from 1 site for their investigations."

Answered by AI

Are there openings available for individuals to participate in this research?

"Affirmative. The information on clinicaltrials.gov reveals that this research is currently seeking out participants. This trial, which was first posted on March 9th 2022, needs 80 individuals from 1 site to complete it successfully."

Answered by AI

Recent research and studies

Contemporary Clinical TrialsJournal

CAPABLE Trial: A Randomized Controlled Trial of Nurse, Occupational Therapist and Handyman to Reduce Disability Among Older Adults: Rationale and Design

Szanton, Sarah L., J.W. Wolff, B. Leff, R.J. Thorpe, E.K. Tanner, C. Boyd, Q. Xue, J. Guralnik, D. Bishai, and L.N. Gitlin. 2014. “CAPABLE Trial: A Randomized Controlled Trial of Nurse, Occupational Therapist and Handyman to Reduce Disability Among Older Adults: Rationale and Design”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2014.03.005.

clinicaltrials.govStudy

CAPABLE Family Pilot - Adapting CAPABLE for Older Adults With Mild Cognitive Impairment (MCI)/Early Stage Dementia and Their Care Partners

2022. "CAPABLE Family Pilot - Adapting CAPABLE for Older Adults With Mild Cognitive Impairment (MCI)/Early Stage Dementia and Their Care Partners". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05187117.

All > Mild Cognitive Impairment