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Evaluation of the PACE/PACENET BHL Caregiver Program (CREST)

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ClinicalTrials.gov Identifier: NCT02463708
Recruitment Status : Enrolling by invitation
First Posted : June 4, 2015
Last Update Posted : August 31, 2022
Sponsor:
Collaborator:
Magellan Health Services
Information provided by (Responsible Party):
Shahrzad Mavandadi, PhD, University of Pennsylvania

Brief Summary:
This project will conduct a retrospective clinical database review and a one-time research interview to evaluate outcomes among a sub-set of caregivers (CGs) who were enrolled in the Behavioral Health Laboratory (BHL) Caregiver Outreach and Telehealth Education Program (COTP). The investigators will recruit CGs whose Care Recipients (CR) met criteria for clinically significant cognitive impairment and/or dementia and who received care management services through the COTP.

Condition or disease Intervention/treatment
Dementia Behavioral: BHL COTP

Detailed Description:

The University of Pennsylvania's Caregiver Resources, Education, & SupporT (CREST) Program seeks to improve the overall quality of life and wellbeing of older PACE/PACENET beneficiaries (or care recipients (CRs)) with cognitive impairment and their caregivers (CGs). Specifically, the program provides education, support, and services to both beneficiaries and CGs of PACE/PACENET beneficiaries who have filled a prescription for medication used to treat cognitive impairment. Many of these beneficiaries also meet criteria for clinically significant cognitive impairment/dementia. Thus, the level of contact and services varies as a function of reported needs and symptoms.

The CREST Program developed the BHL Caregiver Outreach and Telehealth Program (COTP) in an effort to address and minimize barriers to successful care management of a growing number of community-dwelling older adults. The COTP starts with an initial baseline assessment; following the baseline assessment, it is then divided into several core services. CGs receive care management services, which includes contact, support, and active listening, as well as written material regarding caregiving and dementia and referral to appropriate community services. CGs also are offered the Telehealth Education Program (TEP), a manualized program developed to provide both education and psychosocial support for individuals caring for older adults with clinically significant cognitive impairment/dementia.

This research project seeks to evaluate the feasibility, acceptability, and individual-level outcomes of a subset of participants engaged in the COPT program. Specifically, the investigators will examine the impact of the COPT program on the functioning and wellbeing of participating cognitively impaired PACE/PACENET beneficiaries and their informal CGs.

Retrospective clinical program data on COTP beneficiaries and the CGs collected at intake (i.e., baseline), over the course of care management, and at program termination (i.e., approximately 3 months following intake) will be extracted from clinical databases for program evaluation purposes. The researchers will use data collected during the clinical program to evaluate CR and CG characteristics, self-reported needs, care participation, and predictors of improved outcomes at 3 and 6 months.

A single follow-up research evaluation will be conducted at 6 months post baseline. This the 6 month follow-up research interviews will evaluate the extent to which a clinical care management program (COTP) for older adults with clinically significant cognitive impairment and/or dementia and the CGs, 1) facilitates access to and the use of medical and social services, and 2) improves CR (e.g., behavioral symptoms, delayed nursing home placement) and CG (e.g., CG mastery, burden, affect) outcomes.

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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the PACE/PACENET BHL Caregiver Outreach and Telehealth Education Program
Study Start Date : November 2013
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Group/Cohort Intervention/treatment
BHL COTP Caregivers
Caregivers participate in the BHL COTP, which provides support, education, and care management services from a Behavioral Health Provider (BHP) in addition to the Telehealth Education Program (TEP), a manualized program that consists of various modules that seek to provide both education and psychosocial support for individuals caring for older adults with clinically significant cognitive impairment/dementia.
Behavioral: BHL COTP
The BHL COTP starts with an initial baseline assessment; following the baseline assessment, it is then divided into several core services. CG receive care management services, which includes contact, support, and active listening, as well as written material regarding caregiving and dementia and referral to appropriate community services. CGs also are offered the Telehealth Education Program (TEP) a manualized program developed to provide both education and psychosocial support for individuals caring for older adults with clinically significant cognitive impairment/dementia.




Primary Outcome Measures :
  1. Revised Memory and Behavior Problems Checklist [ Time Frame: 6 Months ]
    A checklist for dementia-related symptoms in 3 domains (memory impairment, depression, and disruptive behaviors) and associated CG burden.


Secondary Outcome Measures :
  1. Lawton Caregiver Appraisal Scales [ Time Frame: 6 Months ]
    A scale for caregiver satisfaction, mastery, demands, and perceived impact.

  2. Desire to Institutionalize Scale [ Time Frame: 6 Months ]
    A 6-item scale predictive of CGs actual institutionalization of care recipients.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Caregivers of PACE/PACENET beneficiaries who are participating in the BHL COTP.
Criteria

Inclusion Criteria:

  1. Aged 18 and older, males and females.
  2. The beneficiary screened positive for clinically significant cognitive impairment (BOMC score > 14) during the Care Recipient Baseline BHL COTP interview and agreed to allow COPT staff to speak with a CG, OR, the beneficiary could not complete the Care Recipient Baseline BHL COTP interview at all, agreed to allow COPT staff to speak with a CG on their behalf, and the CG verified that the beneficiary has clinically significant cognitive impairment (via AD8 score of 2 or more) and/or a dementia diagnosis made by a health care provider.
  3. CG provides verbal informed consent to the use of retrospective clinical BHL COTP data and participation in the 6 Month Outcome Research Evaluation at the completion of the 3 Month Program Termination visit.

Exclusion Criteria:

  • Not meeting the inclusion criteria listed above.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02463708


Locations
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United States, Pennsylvania
Department of Psychiatry (Addictions/Geriatric), University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Magellan Health Services
Investigators
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Study Director: Shahrzad Mavandadi, PhD University of Pennsylvania
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shahrzad Mavandadi, PhD, Adjunct Associate Professor of Psychology in Psychiatry, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02463708    
Other Study ID Numbers: 819012
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: August 31, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Shahrzad Mavandadi, PhD, University of Pennsylvania:
Care Giver
Dementia
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders