Evaluation of the PACE/PACENET BHL Caregiver Program

NCT02463708 | Enrolling By Invitation

• 1 other identifier: 819012
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

Care Giver; Dementia

Outcome Measures

Primary Outcomes (1)

• Revised Memory and Behavior Problems Checklist

  A checklist for dementia-related symptoms in 3 domains (memory impairment, depression, and disruptive behaviors) and associated CG burden.

  6 Months

Secondary Outcomes (2)

• Lawton Caregiver Appraisal Scales

  6 Months

• Desire to Institutionalize Scale

  6 Months

Study Arms (1)

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

Interventions

BHL COTP 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.

BHL COTP Caregivers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Caregivers of PACE/PACENET beneficiaries who are participating in the BHL COTP.

You may qualify if:

• Aged 18 and older, males and females.
• 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.
• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Magellan Health Services: collaborator

Study Sites (1)

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

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (5)

• 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.

  PMID: 20507926 BACKGROUND

• 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.

  PMID: 27927725 BACKGROUND

• 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.

  PMID: 28433550 BACKGROUND

• 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.

  PMID: 28134558 BACKGROUND

• 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.

  PMID: 33417236 DERIVED

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Mary Beth Gibbons, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Center for Psychotherapy Research. Professor of Psychiatry, Department of Psychiatry, Perelman School of Medicine

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 4, 2015
• Study Start: November 1, 2013
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)