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Partners in Dementia Care: A Telephone Care Consultation Intervention Provided to Veterans in Partnership With Local Alzheimer's Association Chapters (PDC)

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ClinicalTrials.gov Identifier: NCT00291161
Recruitment Status : Completed
First Posted : February 13, 2006
Results First Posted : May 19, 2016
Last Update Posted : May 19, 2016
Sponsor:
Collaborators:
Benjamin Rose Institute
Alzheimer's Association
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Dementia
Alzheimer Disease
Intervention Behavioral: Partners in Dementia Care
Enrollment 994
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Veterans: Partners in Dementia Care Intervention Veterans: Usual Care Comparison Caregivers: Partners in Dementia Care Intervention Caregivers: Usual Care Comparison
Hide Arm/Group Description A two-person care coordinator team, one based at the VA and one based at the Alzheimer Association, provided telephone-based support to patients with dementia and their caregivers over a 12-month period. The team addressed medical and nonmedical needs through education, coaching, linkages to needed resources, and mobilization of an informal care network. The program consisted of an upfront assessment, development of care goals and action steps, and ongoing monitoring and intervention by the two coordinators, who communicated with each other regularly. Patients and caregivers were provided usual care and an educational booklet on dementia Caregivers for Veterans assigned to the Partners in Dementia Care Intervention Caregivers of the Veterans assigned to the Usual Care Comparison
Period Title: Overall Study
Started 316 192 299 187
Completed 235 134 206 122
Not Completed 81 58 93 65
Arm/Group Title Veterans-PDC Group Veterans-Usual Care Comparison Group Caregivers-PDC Group Caregivers-Usual Care Comparison Group Total
Hide Arm/Group Description Veterans with diagnosed dementia receiving the PDC Intervention Veterans with diagnosed dementia receiving educational materials and usual care Caregivers to veterans with diagnosed dementia receiving the PDC Intervention Caregivers to veterans with diagnosed dementia receiving educational materials and usual care Total of all reporting groups
Overall Number of Baseline Participants 316 192 299 187 994
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 316 participants 192 participants 299 participants 187 participants 994 participants
Age of Veterans 79.4  (8.2) 80.7  (6.2) NA [1]   (NA) NA [1]   (NA) 79.9  (7.6)
Age of Caregivers NA [1]   (NA) NA [1]   (NA) 68.0  (12.6) 70.8  (11.4) 69.1  (12.2)
[1]
Age of veterans measured separate from age of caregivers
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 316 participants 192 participants 299 participants 187 participants 994 participants
Female
11
   3.5%
3
   1.6%
283
  94.6%
178
  95.2%
475
  47.8%
Male
305
  96.5%
189
  98.4%
16
   5.4%
9
   4.8%
519
  52.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 316 participants 192 participants 299 participants 187 participants 994 participants
White nonhispanic 234 178 222 170 804
Black nonhispanic 64 11 56 14 145
Hispanic 12 0 16 0 28
Other 6 3 5 3 17
Number of Caregivers Who were Spouses   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 316 participants 192 participants 299 participants 187 participants 994 participants
Caregivers who were spouses NA [2]  NA [2]  204 149 NA [3] 
Caregivers who were not spouses NA [2]  NA [2]  95 38 NA [3] 
[1]
Measure Description: Was only collected for Caregiver groups
[2]
Was only collected for Caregiver groups
[3]
Total not calculated because data are not available (NA) in one or more arms.
1.Primary Outcome
Title Caregiver Outcomes
Hide Description The following outcomes were measured in Caregivers via scales administered to each caregiver: Unmet need (range=0 to 39, higher meaning more unmet needs); Role captivity (range=0-9, higher indicating greater role captivity); Physical health strain (range=0-9, higher indicating greater health strain); Relationship strain (range=0-18, higher indicating greater relationship strain); Depression (range=0-22, higher indicating greater depression); Caregiver support service use (the number of support services utilized, 0-2); Number of informal helpers (range=0-50, higher indicating more informal helpers)
Time Frame Baseline and at six months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were collected for caregivers only
Arm/Group Title Caregivers: Partners in Dementia Care Intervention Caregivers: Usual Care Comparison
Hide Arm/Group Description:
A two-person care coordinator team, one based at the VA and one based at the Alzheimer Association, provided telephone-based support to patients with dementia and their caregivers over a 12-month period. The team addressed medical and nonmedical needs through education, coaching, linkages to needed resources, and mobilization of an informal care network. The program consisted of an upfront assessment, development of care goals and action steps, and ongoing monitoring and intervention by the two coordinators, who communicated with each other regularly.
Patients and caregivers were provided usual care and an educational booklet on dementia
Overall Number of Participants Analyzed 299 187
Mean (Standard Deviation)
Unit of Measure: units on a scale
Unmet need at Baseline 18.6  (11.8) 14.5  (11.2)
Unmet need at Six months 10.0  (9.9) 10.5  (10.0)
Role Captivity at baseline 3.7  (1.6) 3.5  (1.4)
Role Captivity at 6 months 3.6  (1.6) 3.2  (1.6)
Physical Health Strain at Baseline 3.7  (1.6) 3.6  (1.3)
Physical Health Strain at 6 months 3.5  (1.4) 3.6  (1.5)
Relationship Strain at Baseline 7.2  (2.5) 6.8  (2.1)
Relationship Strain at 6 months 7.0  (2.6) 6.3  (2.3)
Caregiver Support Service use at baseline .4  (.7) .4  (.7)
Caregiver support service at 6 months .7  (.7) .5  (.7)
Depression at baseline 4.5  (3.9) 4.0  (2.9)
Depression at 6 months 4.7  (3.9) 5.0  (4.1)
Number of informal helpers at baseline 4.3  (4.8) 4.3  (5.1)
Number of informal helpers at 6 month 4.7  (5.8) 4.8  (9.1)
2.Primary Outcome
Title Veteran Outcomes
Hide Description The following outcomes were measured for veterans via scales administered to each veteran: Unmet need (range=0 to 24, higher meaning more unmet needs); Embarrassment about memory problems (range=0-3, higher indicating greater embarrassment); Isolation (range=0-4, higher indicating greater isolation); Relationship strain (range=0-4, higher indicating greater relationship strain); Depression (range=0-11, higher indicating greater depression).
Time Frame Baseline - six months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were collected for veterans who could be interviewed only.
Arm/Group Title Partners in Dementia Care Intervention Usual Care Comparison
Hide Arm/Group Description:
A two-person care coordinator team, one based at the VA and one based at the Alzheimer Association, provided telephone-based support to patients with dementia and their caregivers over a 12-month period. The team addressed medical and nonmedical needs through education, coaching, linkages to needed resources, and mobilization of an informal care network. The program consisted of an upfront assessment, development of care goals and action steps, and ongoing monitoring and intervention by the two coordinators, who communicated with each other regularly.
Patients and caregivers were provided usual care and an educational booklet on dementia
Overall Number of Participants Analyzed 152 103
Mean (Standard Deviation)
Unit of Measure: units on a scale
Embarrassment about memory problems at baseline 1.02  (1.19) .89  (1.08)
Embarrassment about memory problems at 6 months .82  (1.09) .91  (1.10)
Depression at baseline 2.68  (2.44) 2.19  (2.10)
Depression at 6 months 2.52  (2.59) 2.37  (2.34)
Unmet need at baseline 7.00  (6.93) 5.44  (6.00)
Unmet need at 6 months 5.05  (6.14) 4.40  (5.58)
Isolation at baseline 1.38  (1.49) 1.06  (1.30)
Isolation at 6 months 1.13  (1.39) 1.09  (1.37)
Relationship strain at baseline .46  (1.04) .38  (.87)
Relationship strain at 6 months .49  (1.02) .32  (.79)
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse Events only assessed for Veterans
 
Arm/Group Title Veterans-PDC Group Veterans-Usual Care Comparison Group
Hide Arm/Group Description Veterans with diagnosed dementia receiving the PDC Intervention Veterans with diagnosed dementia receiving educational materials and usual care
All-Cause Mortality
Veterans-PDC Group Veterans-Usual Care Comparison Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Veterans-PDC Group Veterans-Usual Care Comparison Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/316 (0.00%)   0/192 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Veterans-PDC Group Veterans-Usual Care Comparison Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/316 (0.00%)   0/192 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Mark Kunik, MD, MPH
Organization: Houston HSRD Center of Excellence
Phone: 713-794-8639
Other Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00291161     History of Changes
Other Study ID Numbers: IIR 04-238
First Submitted: February 10, 2006
First Posted: February 13, 2006
Results First Submitted: March 18, 2015
Results First Posted: May 19, 2016
Last Update Posted: May 19, 2016