NCT03447860

Brief Summary

The Primary objective of the study is to evaluate the effectiveness of mindfulness based caregiver intervention, Practice of Acceptance, Awareness, and Compassion in Caregiving (PAACC) compared to an established cognitive behavior therapy based dementia caregiver intervention, Resources for Enhancing Alzheimer's Caregiver Health (REACH) in improving caregiver burden and quality of life of care recipient.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

June 25, 2018

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2023

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

5.4 years

First QC Date

February 21, 2018

Last Update Submit

February 11, 2024

Conditions

Dementia

Outcome Measures

Primary Outcomes (1)

  • Perceived Stress Scale

    The Perceived Stress Scale (PSS) is a 10-item self-report scale developed to measure the degree to which each participant perceives and appraises recent life events as stressful

    4-6 weeks

Study Arms (2)

REACH-VA

ACTIVE COMPARATOR

A cognitive-behavior based multi-component caregiver intervention to reduce caregiver stress.

Behavioral: REACH-VA

PAACC

EXPERIMENTAL

A mindfulness-based multi-component caregiver intervention to reduce caregiver stress.

Behavioral: PAACC

Interventions

PAACCBEHAVIORAL

Mindfulness based caregiver intervention that includes education , problem solving, skill building, stress management and mindfulness to help enhance compassion and acceptance of self and others

PAACC
REACH-VABEHAVIORAL

A cognitive-behavior based multi-component caregiver intervention to reduce caregiver stress

REACH-VA

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Caregivers will include family members living with the individual diagnosed with Alzheimer's Disease( AD) or Alzheimer's disease related dementia(ADRD) or Traumatic Brain Injury -AD(TBI-AD) with moderate to severe caregiver burden .
  • Care recipients with diagnosis of Diagnosis of AD or ADRD or TBI-related AD .

You may not qualify if:

  • Care givers: Determined to be an imminent risk to self or others,the Care recipient currently resides in a nursing home or assisted living facilities, unable to provide their own consent to participate in the study , and active substance use disorder in the last 1yr.
  • Care recipient: Determined to be an imminent risk to self or others, Caregiver is not interested in the study, unable to obtain informed consent from the Care recipient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Boston Health Care system

Brockton, Massachusetts, 02301, United States

Location

Salem VAMC

Salem, Virginia, 24153, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Mamta Sapra, MD

    Salem VAMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Geriatric psychiatrist, MD

Study Record Dates

First Submitted

February 21, 2018

First Posted

February 27, 2018

Study Start

June 25, 2018

Primary Completion

November 12, 2023

Study Completion

November 12, 2023

Last Updated

February 13, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)