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Delivery Models of Caregiver Support and Education

Comparative Effectiveness of Delivery Methods for Caregiver Support and Education

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02368132
Enrollment
319
Registered
2015-02-20
Start date
2016-05-13
Completion date
2021-02-24
Last updated
2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Keywords

Caregivers, Dementia

Brief summary

The proposed study seeks to compare usual care and two different interventions for caregivers (CGs) of Veterans with dementia that are brief and administered by telephone. In the first intervention, care management (i.e., assistance from a nurse or social worker who works with the CG and Veteran's primary care providers), support, psychoeducation, and skills training are tailored to each individual CG and delivered on an individual basis. In the second intervention, care management is tailored and delivered to each individual CG, but support, psychoeducation, and skills training are delivered (also by phone) in a group format. This study will allow us to examine the added benefit of participating in a CG group that provides mutual peer support and feedback. The investigators also will evaluate the extent to which spousal vs. adult child CGs respond differently to the two interventions. Findings will help refine patient/CG-centered care management and support programs designed to facilitate access to services and improve the quality of life of Veterans with dementia and their families.

Detailed description

Background: Existing interventions for informal caregivers (CGs) of care recipients (CRs) with dementia vary on multiple dimensions (e.g., content, administration time, mode of delivery), and findings indicate that these programs are effective in improving CG and CR outcomes. The investigators' team has developed and evaluated two CG programs that are unique in that they are relatively brief (i.e., 3 months) and rely solely on telephone administration. The original program, the Telehealth Education Program (TEP), provides CG support, psychoeducation, and skills training in a group format. The second program adapted the original TEP to be delivered to individual CGs and includes collaborative care management services. Key components of this CR/CG-centered program include direct collaboration among teams of care managers, primary care providers (PCPs), and CGs. The decision to develop an individually-tailored, collaborative care program was partly in response to the success of collaborative care models with other patient populations and the fact that the majority of individuals with dementia receive their healthcare from their PCPs. Nonetheless, an individually-delivered program lacks the benefits derived from the mutual peer support and feedback provided by group-based interventions. What remains to be determined, therefore, is whether modifying the individually-delivered care management program to deliver TEP in a group format is more effective than the individually-delivered program alone. Objectives: The objectives of the project include: a) testing the comparative effectiveness of 2 delivery models (individual TEP + individual care management vs. group TEP + individual care management) of a telephone-based, collaborative dementia care intervention for CGs, and b) exploring whether the individual or individual + group intervention is more effective/acceptable among spousal vs. adult children CGs. Methods: To meet these objectives, the investigators will use a prospective, randomized control group, repeated measures (i.e., baseline, 3, 6, and 12 month follow-up) design. Participants will include 405 CGs (spouses and children 18 years of age and older) of Veterans diagnosed with dementia and receiving routine clinical care at two VA sites. CGs will be recruited for participation if they live with and/or provide 4+ hours of care/day. CGs will be randomly assigned to usual care, the individual intervention, or the individual + group intervention. The main objectives of both interventions are to facilitate resource connection and provide education, psychosocial support, and care management for individuals caring for Veterans with dementia, thereby improving access to and use of non-institutional services, rates of guideline adherent care, and CG/CR outcomes. In both interventions, CGs will receive education, continuous support, skills training, and monitoring of Veterans' medication adherence, symptoms, and service needs. CGs will be asked to complete an assessment battery of standardized measures of CR- and CG-characteristics. Veterans' clinical medical records (including cost data) also will be evaluated for screening and clinical data collection purposes. Generalized estimating equations (GEE) will be the primary method used to analyze the nested, longitudinal data.

Interventions

BEHAVIORALGroup Delivered TEP

All TEP modules will be in a group format. Each call will take 1.5-2 hours. Each group will be comprised of 5-8 CGs who will call into a teleconference line at a pre-specified time. Groups will include spouse/partner-only or adult child-only CGs. The content of the calls will mirror those in the individual TEP delivered program. In addition to the group calls, they will receive individual care management.

BEHAVIORALIndividual Delivered TEP

Two mandatory modules that cover the stages of dementia and provide a brief introduction to problem solving techniques, action plan development, and coping skills, plus a menu of additional modules covering various content areas evaluated during the course of the monthly assessments (e.g., communication skills, behavioral management techniques, stress management and coping skills, longterm planning, etc.). Each individual TEP session will begin with reviewing education related to the selected module. The remainder of each session will involve coaching the caregiver on emotion-focused and problem focused coping strategies. The care manager will also discuss problem solving with the CG to reinforce the action plan and the educational component of the intervention.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Veteran and CG are 18 years of age or older. * Veteran is community dwelling. * Veteran has had at least one PACT encounter at the Corporal Michael J. Crescenz VA Medical Center (CMCVAMC), VA Western New York Healthcare System (VAWNYHS), or affiliated community-based outpatient clinics in the past six months at the time that data is extracted from VINCI for recruitment. * Veteran meets criteria for dementia that is verified by informant report (AD8, score of 2 or above). * CG endorses that Veteran has a diagnosis of dementia. * CG lives with or provides care for the Veteran for an average of at least 4 hours per day. * Veteran's CG is willing and able to provide informed consent. * CG is either a spouse/partner or adult child. * CG screens positive for moderate CG burden (per Zarit Burden Interview (4-item) score of 3 or more).

Exclusion criteria

* CG cognitive, hearing, visual, or other physical impairments leading to difficulty with informed consent process, assessment, or participation in intervention visits. * CG participation in a pre-existing support group or CG intervention at enrollment (however CGs can subsequently enroll in any treatment they choose)

Design outcomes

Primary

MeasureTime frameDescription
Revised Memory and Behavior Problems Checklist (Reaction Subscale)3 MonthsThe Revised Memory and Behavior Problems Checklist (Reaction Subscale) measures CG distress in response to dementia-related symptoms. The RMBPC CG reaction subscale captured how bothered or upset CGs were in response to each endorsed dementia-related symptom (range=0-96, higher scores denote greater distress in response to symptoms)
Zarit Burden Interview (12 Item)3 MonthsThe 12-item Zarit Burden Interview was administered to assess CGs' perceived caregiving burden (range=0-48, higher scores denote greater burden)
Veterans RAND 12-Item Health Survey (VR12)3 MonthsPerceived overall mental wellbeing were assessed with the Mental Component Score (MCS) subscale of the Veterans RAND 12-Item Health Survey (VR12). Higher scores denote greater mental wellbeing (range: 0-100)

Countries

United States

Participant flow

Recruitment details

Caregivers (CGs) of Veterans with dementia receiving primary care at the Corporal Michael J. Crescenz VA Medical Center, VA Western New York Healthcare System, and their affiliated outpatient clinics were recruited and enrolled between May 2016 and November 2019. Participants were sent a letter introducing them to the study following either direct provider referral or upon a review of lists of patients prescribed memory-enhancing medications generated from the electronic medical record.

Participants by arm

ArmCount
Usual Care
Caregivers randomized to UC will be sent general material about VA and community resources for patients with dementia and their CGs. With the exception of this material, individuals in this group will receive usual care and will be contacted again at 3, 6, and 12 months for follow-up research assessments.
112
Individual Delivered TEP Arm
Two mandatory modules that cover the stages of dementia and provide a brief introduction to problem solving techniques, action plan development, and coping skills, plus a menu of additional modules covering various content areas evaluated during the course of the monthly assessments (e.g., communication skills, behavioral management techniques, stress management and coping skills, longterm planning, etc.). Each individual TEP session will begin with reviewing education related to the selected module. The remainder of each session will involve coaching the caregiver on emotion-focused and problem focused coping strategies. The care manager will also discuss problem solving with the CG to reinforce the action plan and the educational component of the intervention.
122
Group Delivered TEP Arm
All TEP modules will be in a group format. Each call will take 1.5-2 hours. Each group will be comprised of 5-8 CGs who will call into a teleconference line at a pre-specified time. Groups will include spouse/partner-only or adult child-only CGs. The content of the calls will mirror those in the individual TEP delivered program. In addition to the group calls, they will receive individual care management.
85
Total319

Baseline characteristics

CharacteristicUsual CareIndividual Delivered TEP ArmGroup Delivered TEP ArmTotal
Age, Continuous71.31 years
STANDARD_DEVIATION 11.36
72.20 years
STANDARD_DEVIATION 11.45
71.42 years
STANDARD_DEVIATION 11.12
71.68 years
STANDARD_DEVIATION 11.3
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
24 Participants23 Participants15 Participants62 Participants
Race (NIH/OMB)
More than one race
1 Participants1 Participants0 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants8 Participants1 Participants15 Participants
Race (NIH/OMB)
White
81 Participants89 Participants69 Participants239 Participants
Region of Enrollment
United States
112 Participants122 Participants85 Participants319 Participants
Revised Memory and Behavior Problem Checklist (CG Reaction Score)16.23 score on a measure
STANDARD_DEVIATION 11.29
20.48 score on a measure
STANDARD_DEVIATION 14.17
17.88 score on a measure
STANDARD_DEVIATION 12.38
18.29 score on a measure
STANDARD_DEVIATION 12.83
Sex: Female, Male
Female
104 Participants114 Participants80 Participants298 Participants
Sex: Female, Male
Male
8 Participants8 Participants5 Participants21 Participants
VR 12 - Mental Component Score48.45 score on a measure
STANDARD_DEVIATION 9.02
43.07 score on a measure
STANDARD_DEVIATION 11.38
45.88 score on a measure
STANDARD_DEVIATION 11.08
44.24 score on a measure
STANDARD_DEVIATION 11.32
Zarit Burden Interview15.98 score on a measure
STANDARD_DEVIATION 7.4
20.29 score on a measure
STANDARD_DEVIATION 9.04
19.63 score on a measure
STANDARD_DEVIATION 9.09
18.63 score on a measure
STANDARD_DEVIATION 8.72

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 1120 / 1220 / 85
other
Total, other adverse events
0 / 1120 / 1220 / 85
serious
Total, serious adverse events
3 / 1127 / 1226 / 85

Outcome results

Primary

Revised Memory and Behavior Problems Checklist (Reaction Subscale)

The Revised Memory and Behavior Problems Checklist (Reaction Subscale) measures CG distress in response to dementia-related symptoms. The RMBPC CG reaction subscale captured how bothered or upset CGs were in response to each endorsed dementia-related symptom (range=0-96, higher scores denote greater distress in response to symptoms)

Time frame: 3 Months

Population: Intent-to-treat analysis included all randomized participants

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Usual CareRevised Memory and Behavior Problems Checklist (Reaction Subscale)19.46 score on a scaleStandard Error 1.97
Individual Delivered TEP ArmRevised Memory and Behavior Problems Checklist (Reaction Subscale)14.31 score on a scaleStandard Error 1.41
Group Delivered TEP ArmRevised Memory and Behavior Problems Checklist (Reaction Subscale)10.73 score on a scaleStandard Error 1.65
p-value: <0.001Mixed Models Analysis
p-value: 0.04Mixed Models Analysis
Primary

Veterans RAND 12-Item Health Survey (VR12)

Perceived overall mental wellbeing were assessed with the Mental Component Score (MCS) subscale of the Veterans RAND 12-Item Health Survey (VR12). Higher scores denote greater mental wellbeing (range: 0-100)

Time frame: 3 Months

Population: Intent-to-treat analysis included all randomized participants

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Usual CareVeterans RAND 12-Item Health Survey (VR12)49.28 score on a scaleStandard Error 1.52
Individual Delivered TEP ArmVeterans RAND 12-Item Health Survey (VR12)45.29 score on a scaleStandard Error 1.11
Group Delivered TEP ArmVeterans RAND 12-Item Health Survey (VR12)46.20 score on a scaleStandard Error 1.32
Primary

Zarit Burden Interview (12 Item)

The 12-item Zarit Burden Interview was administered to assess CGs' perceived caregiving burden (range=0-48, higher scores denote greater burden)

Time frame: 3 Months

Population: Intent-to-treat analysis included all randomized participants

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Usual CareZarit Burden Interview (12 Item)16.66 score on a scaleStandard Error 1.25
Individual Delivered TEP ArmZarit Burden Interview (12 Item)17.95 score on a scaleStandard Error 0.93
Group Delivered TEP ArmZarit Burden Interview (12 Item)17.37 score on a scaleStandard Error 1.09

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026