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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Veterans: Partners in Dementia Care Intervention 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.
Veterans: Usual Care Comparison Patients and caregivers were provided usual care and an educational booklet on dementia
Caregivers: Partners in Dementia Care Intervention Caregivers for Veterans assigned to the Partners in Dementia Care Intervention
Caregivers: Usual Care Comparison Caregivers of the Veterans assigned to the Usual Care Comparison

Participant Flow:   Overall Study
    Veterans: Partners in Dementia Care Intervention   Veterans: Usual Care Comparison   Caregivers: Partners in Dementia Care Intervention   Caregivers: Usual Care Comparison
STARTED   316   192   299   187 
COMPLETED   235   134   206   122 
NOT COMPLETED   81   58   93   65 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Veterans-PDC Group Veterans with diagnosed dementia receiving the PDC Intervention
Veterans-Usual Care Comparison Group Veterans with diagnosed dementia receiving educational materials and usual care
Caregivers-PDC Group Caregivers to veterans with diagnosed dementia receiving the PDC Intervention
Caregivers-Usual Care Comparison Group Caregivers to veterans with diagnosed dementia receiving educational materials and usual care
Total Total of all reporting groups

Baseline Measures
   Veterans-PDC Group   Veterans-Usual Care Comparison Group   Caregivers-PDC Group   Caregivers-Usual Care Comparison Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 316   192   299   187   994 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
         
Age of Veterans   79.4  (8.2)   80.7  (6.2)   NA [1]   NA [1]   79.9  (7.6) 
Age of Caregivers   NA [1]   NA [1]   68.0  (12.6)   70.8  (11.4)   69.1  (12.2) 
[1] Age of veterans measured separate from age of caregivers
Gender 
[Units: Participants]
         
Female   11   3   283   178   475 
Male   305   189   16   9   519 
Race/Ethnicity, Customized 
[Units: 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] [2] 
[Units: Participants]
         
Caregivers who were spouses   NA [1]   NA [1]   204   149   NA [2] 
Caregivers who were not spouses   NA [1]   NA [1]   95   38   NA [2] 
[1] Was only collected for Caregiver groups
[2] Total not calculated because data are not available (NA) in one or more arms.


  Outcome Measures

1.  Primary:   Caregiver Outcomes   [ Time Frame: Baseline and at six months ]

2.  Primary:   Veteran Outcomes   [ Time Frame: Baseline - six months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: kunik.marke@va.gov


Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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