SCAN Memory Program Evaluation Study

Dementia Clinical Trial

— SMPES  

Official title:

SCAN Memory Program Evaluation Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01182987
• Other study ID #: SRC 09-002
• Status: Recruiting
• Phase: N/A
• First received: August 16, 2010
• Last updated: August 16, 2010
• Start date: October 2009
• Est. completion date: March 2012

Study information

• Verified date: August 2010
• Source: VA Greater Los Angeles Healthcare System
• Contact: Joshua Chodosh, MD, MSHS
• Phone: 310-268-3361
• Email: jchodosh[@]mednet.ucla.edu
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The SCAN Memory Program Evaluation study is an evaluation of a randomized controlled trial intervention consisting of a care management program for cognitively-impaired health plan members and for their informal/family caregivers. The program includes collaboration between the health plan, partnering medical groups, and community organizations.

Program activities include: 1) telephonic-structured assessments with informal caregivers conducted by SCAN Memory Program care managers; 2) problem identification as a result of these assessments; and 3) pre-established protocols and procedures for problem resolution. ACCESS, the prototype for the SCAN Memory Program, was developed and tested in San Diego County and was very successful in helping affected patients and their caregivers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: Health plan member eligibility includes having a visit-based ICD-9 diagnostic code for dementia or a dementia-specific medication (including donepezil, rivastigmine, galantamine, and memantine) within administrative data any time prior to data inquiry for potential subjects. The health plan member must have a caregiver who can communicate by telephone and though that person might also be a health plan member, health plan membership for caregivers is not required. All subjects must be living in the community and if in a nursing facility, this must be for rehabilitation or respite care but not for long term care. Caregivers must be able to communicate in English or Spanish.

Exclusion Criteria: Person with dementia whose potential participation is declined by their physician. Those who do not have a family or informal caregiver cannot participate and caregivers who do no have telephone access or the capacity to consent to research evaluation are excluded. Patients who reside in nursing facilities as permanent residents are not eligible.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• Dementia Care Management
The SCAN Memory Program is a care management program for cognitively-impaired SCAN members and for their informal/family caregivers. The program includes collaboration between SCAN Health Plan, partnering medical groups, and community organizations. Program activities include: 1) telephonic-structured assessments with informal caregivers conducted by SCAN Memory Program care managers; 2) problem identification as a result of these assessments; and 3) pre-established protocols and procedures for problem resolution.

Locations

Country	Name	City	State
United States	Davis Research	Calabasas	California
United States	VA Greater Los Angeles Healthcare System	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Greater Los Angeles Healthcare System	University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Guideline Adherence	Quality of care process measures will be examined that reflect practice guideline quality indicators measuring patient and caregiver assessment, treatment, education and support, and safety. Measures are collected at 9 and 18 months using caregiver surveys and medical record abstraction.	18 months of longer	No
Primary	Program feasibility and fidelity	Formative Evaluation consisting of a series of stakeholder semi-structured interviews and data abstraction to monitor the activities of healthplan care managers will be collected at pre-specificed intervals and results will be provivided periodically to the healthplan for ongoing improvements in program delivery.	6 to 18 months	No
Primary	Healthcare utilization	Caregiver specific utilization including use of services that care managers may recommend to them and the dementia patient. Emergency department, hospitalization and ambulatory visits data will also be collected through administrative data and caregiver surveys.	18 months	No
Secondary	Behavioral disturbance	Neuropsychiatric inventory questionnaire (NPI-Q)as a caregiver derived assessment on caregiver surveys conducted at baseline, 9 and 18 months.	9 months and 18 months	No
Secondary	Functional Status	Using an informant (caregiver)-based measure of 10 complex higher order activities using the Functional Activities Questionnaire (FAQ). This is a reliable measure of functional status in patients with dementia.	9 and 18 months	No
Secondary	Quality of life	Patient health related quality of life (HRQOL) using the Health Utilities Index	9 and 18 months	No
Secondary	Quality of Care	Using caregiver surveys, this will be measured with a 5-item scale from the Consumer Assessment of Health Plans Survey 2.0.	9 and 18 months	No
Secondary	Caregiver self-efficacy	caregiver confidence using a 6-item measure that was utilized in prior care management clinical trials	9 months and 18 months	No
Secondary	Caregiver unmet need for assistance	a 2-item, 3-point scale for each covering general caregiveing - bathing, dressing, and transportation	9 months and 18 months	No
Secondary	Caregiver social support	This will be measured in caregiver surveys using a 5-item measure derived from the Medical Outcomes study Social Support Survey (MSSS).	9 months and 18 months	No
Secondary	Caregiver burden	The 22-item Burden Interview is a widely used validated measure to assess stressors experienced by caregivers of persons with dementia. Each itme uses a 5-point scale (response set).	9 months and 18 months	No
Secondary	Caregiver depression	The Patient Health Questionnaire - Nine (PHQ-9) will be included in caregiver surveys at baseline, 9 and 18 months as a measure of depressive symptoms over the preceding 2 weeks.	9 months and 18 months	No