Optimizing Dementia Care

NCT02585232 | Completed Results DMC

• 1 other identifier: D1824-W
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized controlled pilot study is to examine the preliminary effectiveness, feasibility, and potential treatment moderators (i.e., behavioral symptoms and spousal relationship status) of a newly developed intervention for individuals with dementia and their family caregivers that combines elements of the established care consultation (CC) approach with additional counseling modules (CC+C). Outcomes for Veterans with dementia and their family caregivers (e.g., depressive symptoms, care-related burden, quality of life, pleasant events, etc.) will be assessed after 6 months of treatment and again at 12 months.

Conditions

Alzheimer's Disease; Dementia; Dementia, Vascular; Caregivers; Veterans

Keywords

Behavioral sciences; Counseling; Intervention Studies; Cognitive Behavioral Therapy; Telemedicine; Mindfulness

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Caregiver Burden Scores on the Zarit Caregiver Burden Inventory

  The Zarit Caregiver Burden Inventory is a measure of strain related to providing care for someone with dementia. Scores range from 0 to 48 with higher scores indicating more caregiver burden.

  Baseline, 6 months

• Change From Baseline in Relationship Cohesion on the Dyadic Adjustment Scale

  Relationship satisfaction and cohesion measure for spouses and partners in a romantic relationship. Scores range from 0 to 151, and higher scores indicate higher levels of relationship satisfaction. Not all caregivers were in a romantic relationship with the person with dementia, this scale was only administered to dyads who were married or partnered (e.g., adult children caregivers would not have received this measure).

  Baseline, 6 months

• Change From Baseline in Quality of Life on the World Health Organization (WHO) Quality of Life Measure

  Change in shared pleasant events, social engagement, and quality of life is hypothesized to be greater in caregivers assigned to CC+C than in CC alone at 6 months. Scores range from 19 to 95, and higher scores indicate better quality of life.

  Baseline, 6 months

• Change From Baseline Depressive Symptoms on the Cornell Scale for Depression in Dementia

  Depression symptoms measure, scores range from 0 to 38 with higher scores indicating more depressive symptoms as rated by their caregiver.

  Baseline, 6 months

Secondary Outcomes (1)

• Number and Percentage of Veterans With Dementia in Long-term Care Facilities as Reported by the Caregivers at 12 Months

  12 months

Study Arms (2)

Care Consultation (CC)

ACTIVE COMPARATOR

Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the care consultant through a standardized delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the "initial assessment" - much like an interview guide - which then immediately shapes development of concrete action plans.

Behavioral: Care Consultation (CC)

Care Consultation + Counseling (CC+C)

EXPERIMENTAL

Care Consultation + Counseling (CC+C): is consistent with the original CC protocol in that the therapist partners with each dyad in a patient-centered way to prioritize unmet needs as identified during the CC initial assessment. Once this phase has been completed, typically within the first 2 sessions, the CC+C therapist will determine when to initiate counseling sessions targeting 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.). The counseling component of the CC+C intervention incorporates elements of existing manualized interventions that have been tailored for this population and follow a cognitive behavioral therapy framework.

Behavioral: Counseling (C); Behavioral: Care Consultation (CC)

Interventions

Counseling (C) BEHAVIORAL

The counseling component incorporates elements of existing manualized interventions that have been tailored for this population and follow a cognitive behavioral therapy framework. Counseling sessions will be completed for 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.).

Care Consultation + Counseling (CC+C)

Care Consultation (CC) BEHAVIORAL

Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the care consultant through a standardized delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the "initial assessment," which then immediately shapes development of concrete action plans.

Care Consultation (CC); Care Consultation + Counseling (CC+C)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans:
• Must be age 19 or older
• Must have a diagnosis of dementia or a related disorder
• Must live in the community (i.e. not in a VA Community Living Center, nursing home, or other facility)
• Must cohabitate with a caregiver
• Must have reliable access to a telephone
• Must be willing to consent to participate or provide assent in conjunction with proxy consent if their decision-making capacity is compromised
• Caregivers:
• Must be age 19 or older
• Must self-identify as assisting with care for at least 8 hours/week
• Must be willing to consent to participate

You may not qualify if:

• Veterans:
• Currently incarcerated
• Currently pregnant
• Dyads experiencing low levels of distress
• Caregivers:
• Currently incarcerated
• Currently pregnant
• Experiencing severe cognitive impairment that would impair their ability to communicate during an interview
• Dyads experiencing low levels of distress

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Tuscaloosa VA Medical Center, Tuscaloosa, AL

Tuscaloosa, Alabama, 35404, United States

Location

Related Publications (4)

• Judge KS, Bass DM, Snow AL, Wilson NL, Morgan R, Looman WJ, McCarthy C, Kunik ME. Partners in dementia care: a care coordination intervention for individuals with dementia and their family caregivers. Gerontologist. 2011 Apr;51(2):261-72. doi: 10.1093/geront/gnq097. Epub 2011 Jan 17.

  PMID: 21242317 BACKGROUND

• Bass DM, Judge KS, Snow AL, Wilson NL, Morgan R, Looman WJ, McCarthy CA, Maslow K, Moye JA, Randazzo R, Garcia-Maldonado M, Elbein R, Odenheimer G, Kunik ME. Caregiver outcomes of partners in dementia care: effect of a care coordination program for veterans with dementia and their family members and friends. J Am Geriatr Soc. 2013 Aug;61(8):1377-86. doi: 10.1111/jgs.12362. Epub 2013 Jul 19.

  PMID: 23869899 BACKGROUND

• Bass DM, Judge KS, Snow AL, Wilson NL, Morgan RO, Maslow K, Randazzo R, Moye JA, Odenheimer GL, Archambault E, Elbein R, Pirraglia P, Teasdale TA, McCarthy CA, Looman WJ, Kunik ME. A controlled trial of Partners in Dementia Care: veteran outcomes after six and twelve months. Alzheimers Res Ther. 2014 Feb 28;6(1):9. doi: 10.1186/alzrt242. eCollection 2014.

  PMID: 24764496 BACKGROUND

• Bass DM, Clark PA, Looman WJ, McCarthy CA, Eckert S. The Cleveland Alzheimer's managed care demonstration: outcomes after 12 months of implementation. Gerontologist. 2003 Feb;43(1):73-85. doi: 10.1093/geront/43.1.73.

  PMID: 12604748 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Dementia, Vascular

Interventions

Counseling

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Michelle Hilgeman
• Organization: Tuscaloosa VA Medical Center

Michelle.Hilgeman@va.gov

205-554-2000

Study Officials

• Michelle M Hilgeman, PhD

  Tuscaloosa VA Medical Center, Tuscaloosa, AL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 23, 2015
• Study Start: October 1, 2016
• Primary Completion: August 5, 2020
• Study Completion: October 22, 2020
• Last Updated: January 11, 2022
• Results First Posted: September 13, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)