Evaluation of the PACE/PACENET BHL Caregiver Program

NCT ID: NCT02463708

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dementia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

BHL COTP

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Magellan Health Services

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Mary Beth Gibbons, Ph.D.

Director of Center for Psychotherapy Research. Professor of Psychiatry, Department of Psychiatry, Perelman School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary Beth Gibbons, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Department of Psychiatry (Center for Psychotherapy Research), University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Wray LO, Shulan MD, Toseland RW, Freeman KE, Vasquez BE, Gao J. The effect of telephone support groups on costs of care for veterans with dementia. Gerontologist. 2010 Oct;50(5):623-31. doi: 10.1093/geront/gnq040. Epub 2010 May 27.

Reference Type BACKGROUND
PMID: 20507926 (View on PubMed)

Mavandadi S, Patel S, Benson A, DiFilippo S, Streim J, Oslin D. Correlates of Caregiver Participation in a Brief, Community-Based Dementia Care Management Program. Gerontologist. 2017 Nov 10;57(6):1103-1112. doi: 10.1093/geront/gnw127.

Reference Type BACKGROUND
PMID: 27927725 (View on PubMed)

Mavandadi S, Wray LO, DiFilippo S, Streim J, Oslin D. Evaluation of a Telephone-Delivered, Community-Based Collaborative Care Management Program for Caregivers of Older Adults with Dementia. Am J Geriatr Psychiatry. 2017 Sep;25(9):1019-1028. doi: 10.1016/j.jagp.2017.03.015. Epub 2017 Mar 27.

Reference Type BACKGROUND
PMID: 28433550 (View on PubMed)

Mavandadi S, Wright EM, Graydon MM, Oslin DW, Wray LO. A randomized pilot trial of a telephone-based collaborative care management program for caregivers of individuals with dementia. Psychol Serv. 2017 Feb;14(1):102-111. doi: 10.1037/ser0000118.

Reference Type BACKGROUND
PMID: 28134558 (View on PubMed)

Gonzalez-Fraile E, Ballesteros J, Rueda JR, Santos-Zorrozua B, Sola I, McCleery J. Remotely delivered information, training and support for informal caregivers of people with dementia. Cochrane Database Syst Rev. 2021 Jan 4;1(1):CD006440. doi: 10.1002/14651858.CD006440.pub3.

Reference Type DERIVED
PMID: 33417236 (View on PubMed)

Other Identifiers

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819012

Identifier Type: -

Identifier Source: org_study_id

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