NCT00291161

Brief Summary

Background: Partners in Dementia Care (PDC) is a care coordination and support service intervention for veterans with dementia and their family caregivers, delivered through partnerships between VA medical centers and local Alzheimer's Association Chapters. PDC was designed to be a feasible and practical intervention to integrate health, community, and support services. PDC has a standardized protocol for care coordination and support services, including guidelines for care plan assessment, care plan development and implementation, ongoing monitoring, and reassessment. It also offers a structured training curriculum for providers and an operations manual for uniform implementation. Objectives: The primary objective was to test the impact of PDC on outcomes for veterans with dementia and family caregivers. Two specific research objectives and corresponding hypotheses were addressed: 1. To test the impact of PDC on three categories of outcomes: psychosocial well-being outcomes (patient and caregiver effects); health care service use (patient effects only); and health care cost (patient effects only). HI:PDC, compared to usual care, will improve psychosocial well-being for patients with dementia and their caregivers. H2:PDC, compared to usual care, will reduce health care service use for patients with dementia. H3:PDC is preferred to usual care based on cost-benefit analyses. H4:The PDC intervention will be more effective in improving psychosocial well-being and reducing health care service use for patients and caregivers dealing with more severe patient impairment (e.g., cognitive status, functional status, and level of problem behaviors). 2. To evaluate the impact of PDC on role and intra-psychic strains caused by dementia and its care (patient and caregiver effects). H5a:PDC, compared to usual care, will decrease patient role and intra-psychic strain. H5b:PDC, compared to usual care, will decrease caregiver role and intra-psychic strain. H6:The PDC intervention will be more effective in decreasing role and intra-psychic strains for patients and caregivers dealing with more severe patient impairment (e.g., cognitive status, functional status, and level of problem behaviors).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
994

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 13, 2006

Completed
10 months until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

May 19, 2016

Completed
Last Updated

May 19, 2016

Status Verified

May 1, 2016

Enrollment Period

3.8 years

First QC Date

February 10, 2006

Results QC Date

March 18, 2015

Last Update Submit

May 10, 2016

Conditions

Keywords

Delivery of Health Care, IntegratedUnited States Department of Veterans AffairsDementiaPatient Care Management

Outcome Measures

Primary Outcomes (2)

  • Caregiver Outcomes

    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)

    Baseline and at six months

  • Veteran Outcomes

    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).

    Baseline - six months

Study Arms (2)

Partners in Dementia Care

EXPERIMENTAL

PDC is telephone-based care consultation intervention jointly delivered by care consultants in the VA and local Alzheimer's Association. The steps in care consultation included 1) Assessment of medical and non-medical care needs; 2) Development of a care plan that addresses needs of patients and caregivers; 3) on-going monitoring of the status, progress, and barriers encountered; and 4) Reassessment of care needs for patients and caregivers. PDC assisted families by: 1) providing disease-related education and information, 2) offering emotional support and coaching, 3) linking families to medical and non-medical services and resources, and 4) mobilizing and organizing the informal care network.

Behavioral: Partners in Dementia Care

Usual Care

NO INTERVENTION

Patients and caregivers at the three control VA settings were given a packet of educational materials on dementia and usual-care community resources.

Interventions

Partners in Dementia Care is facilitated by the VA Dementia care coordinator (VA DCC) that is with the study. The role of the VA DCC includes conducting initial assessments with the subject and caregiver that leads to: Arranging for further assessment or attention from VA health care system/providers about dementia related concerns or about co-morbid health issues; for example: VA driving evaluation, congestive heart failure medication adherence; Ensuring education is provided about particular health, safety issues; Following up with patient/caregiver on health promoting activities he/she is committed to do; and Sharing care plan actions/outcomes with other VA providers as agreed upon by patient.

Partners in Dementia Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dementia Diagnosis
  • veteran
  • reside outside of a long-term care facility
  • live within local Alzheimer Association chapter service of Houston, Oklahoma City, Boston, or Providence

You may not qualify if:

  • Live in long-term care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

VA Boston Health Care System, Jamaica Plain

Boston, Massachusetts, 02130, United States

Location

VA Boston Healthcare System, Brockton Campus

Brockton, Massachusetts, 02301, United States

Location

Oklahoma City, OK

Oklahoma City, Oklahoma, 73104, United States

Location

VA Medical Center, Providence

Providence, Rhode Island, 02908-4799, United States

Location

Beaumont VA Outpatient Clinic

Beaumont, Texas, 77707, United States

Location

Michael E DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (14)

  • Shrestha S, Judge KS, Wilson NL, Moye JA, Snow AL, Kunik ME. Utilization of legal and financial services of partners in dementia care study. Am J Alzheimers Dis Other Demen. 2011 Mar;26(2):115-20. doi: 10.1177/1533317510394156. Epub 2011 Jan 13.

    PMID: 21233136BACKGROUND
  • 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: 21242317BACKGROUND
  • Bradford A, Upchurch C, Bass D, Judge K, Snow AL, Wilson N, Kunik ME. Knowledge of documented dementia diagnosis and treatment in veterans and their caregivers. Am J Alzheimers Dis Other Demen. 2011 Mar;26(2):127-33. doi: 10.1177/1533317510394648. Epub 2011 Jan 27.

    PMID: 21273206BACKGROUND
  • Weber SR, Pirraglia PA, Kunik ME. Use of services by community-dwelling patients with dementia: a systematic review. Am J Alzheimers Dis Other Demen. 2011 May;26(3):195-204. doi: 10.1177/1533317510392564. Epub 2011 Jan 27.

    PMID: 21273207BACKGROUND
  • Shub D, Bass DM, Morgan RO, Judge KS, Snow AL, Wilson NL, Walder A, Murry B, Kunik ME. Irritability and social isolation in dementia patients with and without depression. J Geriatr Psychiatry Neurol. 2011 Dec;24(4):229-34. doi: 10.1177/0891988711427039.

    PMID: 22228830BACKGROUND
  • Bass DM, Judge KS, Snow AL, Wilson NL, Looman WJ, McCarthy C, Morgan R, Ablorh-Odjidja C, Kunik ME. Negative caregiving effects among caregivers of veterans with dementia. Am J Geriatr Psychiatry. 2012 Mar;20(3):239-47. doi: 10.1097/JGP.0b013e31824108ca.

    PMID: 22251867BACKGROUND
  • Bejjani C, Snow AL, Judge KS, Bass DM, Morgan RO, Wilson N, Walder A, Looman WJ, McCarthy C, Kunik ME. Characteristics of Depressed Caregivers of Veterans With Dementia. Am J Alzheimers Dis Other Demen. 2015 Nov;30(7):672-8. doi: 10.1177/1533317512461555. Epub 2012 Oct 14.

    PMID: 23070578BACKGROUND
  • Godwin KM, Morgan RO, Walder A, Bass DM, Judge KS, Wilson N, Snow AL, Kunik ME. Predictors of Inpatient Utilization among Veterans with Dementia. Curr Gerontol Geriatr Res. 2014;2014:861613. doi: 10.1155/2014/861613. Epub 2014 May 29.

    PMID: 24982674BACKGROUND
  • Ng S, Morgan RO, Walder A, Biswas J, Bass DM, Judge KS, Snow AL, Wilson N, Kunik ME. Functional Decline Predicts Emergency Department Use in Veterans With Dementia. Am J Alzheimers Dis Other Demen. 2014 Jun;29(4):362-71. doi: 10.1177/1533317513518655. Epub 2014 Jan 9.

    PMID: 24413540BACKGROUND
  • Steiger-Gallagher K, Bass DM, Judge KS, Snow L, Wilson NL, Morgan RO, Walder A, Kunik ME. Satisfaction with dementia care. Federal practitioner : for the health care professionals of the VA, DoD, and PHS. 2012 Apr 1; 29(4):33-40.

    RESULT
  • 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.

  • 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.

  • Morgan RO, Bass DM, Judge KS, Liu CF, Wilson N, Snow AL, Pirraglia P, Garcia-Maldonado M, Raia P, Fouladi NN, Kunik ME. A break-even analysis for dementia care collaboration: Partners in Dementia Care. J Gen Intern Med. 2015 Jun;30(6):804-9. doi: 10.1007/s11606-015-3205-x. Epub 2015 Feb 10.

  • Bass DM, Judge KS, Maslow K, Wilson NL, Morgan RO, McCarthy CA, Looman WJ, Snow AL, Kunik ME. Impact of the care coordination program "Partners in Dementia Care" on veterans' hospital admissions and emergency department visits. Alzheimers Dement (N Y). 2015 Apr 17;1(1):13-22. doi: 10.1016/j.trci.2015.03.003. eCollection 2015 Jun.

Related Links

MeSH Terms

Conditions

DementiaAlzheimer Disease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative Diseases

Results Point of Contact

Title
Mark Kunik, MD, MPH
Organization
Houston HSRD Center of Excellence

Study Officials

  • Mark E Kunik, MD MPH

    Michael E. DeBakey VA Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

February 10, 2006

First Posted

February 13, 2006

Study Start

December 1, 2006

Primary Completion

September 1, 2010

Study Completion

February 1, 2011

Last Updated

May 19, 2016

Results First Posted

May 19, 2016

Record last verified: 2016-05

Locations