All > Mild Cognitive Impairment

CAPABLE Family for Depression

Johns Hopkins School of Nursing, Baltimore, MD
Depression+13 More ConditionsCAPABLE Family - Behavioral
Eligibility
18+
All Sexes

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.

Eligible Conditions
  • Depression
  • Caregiver Burden
  • Caregiver Burnout
  • Quality of Life
  • Cognitive Impairment
  • Mild Cognitive Impairment
  • Physical Disabilities

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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3
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2
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Study Objectives

9 Primary · 0 Secondary · Reporting Duration: 16 weeks, 32 weeks

16 weeks
Satisfaction at endpoint of intervention as assessed by qualitative questions
16 weeks, 32 weeks
Change in Perceived Change in Function Scale Score
Change in caregiving burden as assessed by the Perceived Change Index Scale
8 weeks
Satisfaction at midpoint of intervention assessed by qualitative questions
Baseline
Level of Cognitive Impairment for eligibility as assessed by the Montreal Cognitive Assessment (MoCA) Blind/Telephone
Week 32
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
Change in Pain as assessed by the Brief Pain Inventory (Short Form)

Trial Safety

Phase-Based Safety

1 of 3

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2
VSOP
3
Spironolactone
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

3 Treatment Groups

Randomized Control Pilot - Waitlist Control Arm
1 of 3
Open Label Pilot
1 of 3
Randomized Control Pilot - Intervention Arm
1 of 3

Active Control

Experimental Treatment

80 Total Participants · 3 Treatment Groups

Primary Treatment: CAPABLE Family · No Placebo Group · N/A

Open Label PilotExperimental Group · 2 Interventions: CAPABLE Family, CAPABLE Family - Open Label Pilot · Intervention Types: Behavioral, Behavioral
Randomized Control Pilot - Intervention ArmExperimental Group · 2 Interventions: CAPABLE Family, CAPABLE Family - Randomized Control Trial · Intervention Types: Behavioral, Behavioral
Randomized Control Pilot - Waitlist Control ArmActiveComparator Group · 2 Interventions: CAPABLE Family, CAPABLE Family - Randomized Control Trial · Intervention Types: Behavioral, Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 16 weeks, 32 weeks

Who is running the clinical trial?

The Rita and Alex Hillman FoundationUNKNOWN
National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
58 Previous Clinical Trials
7,003 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,117 Previous Clinical Trials
32,579,308 Total Patients Enrolled
52 Trials studying Depression
27,904 Patients Enrolled for Depression
Sarah Szanton, PhD, RN, FAANPrincipal InvestigatorJohns Hopkins School of Nursing
Sarah Szanton, PhD, RNPrincipal InvestigatorJohns Hopkins School of Nursing

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed by a doctor with mild cognitive impairment or mild dementia, or you have reported difficulties with thinking and memory. Your score on a cognitive test called the Montreal Cognitive Assessment (MoCA) is between 16 and 23.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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