DementiaSMPESNCT01182987
SCAN Memory Program Evaluation Study
A study testing Dementia Care Management in people with Dementia, run by VA Greater Los Angeles Healthcare System at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Dementia Care Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2009to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Davis Research
Calabasas, California
Jason Kerns, 818-223-4046, jkerns@davisresearch.com
Nicole Cullen, ncullen@davisresearch.com
- Recruiting
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Joshua Chodosh, MD, MSHS, 310-268-3361, jchodosh@mednet.ucla.edu
Karen Connor, RN, MBA, PhD, 310-268-3975, kiconnor@ucla.edu
About this study
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.
- Conditions
- Dementia
- Being tested
- Dementia Care Management
- Keywords
- Quality improvement, Quality of care, Health care utilization, Behavioral change
- Medical subject headings
- Dementia, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dementia Care ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Dementia care management | Active comparator | Patients and family caregivers will be offered dementia care management, which includes detailed comprehensive assessment, education, counseling, referrals to community agencies, collaboration with medical providers and frequent telephone follow-up Receives: Behavioral: Dementia Care Management |
| Usual care | No intervention | Patients and care family care givers will receive usual support and medical care offered by the health plan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months of longer
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.
Measured: 6 to 18 months
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.
Measured: 18 months
Secondary outcomes (9)
Behavioral disturbance
Neuropsychiatric inventory questionnaire (NPI-Q)as a caregiver derived assessment on caregiver surveys conducted at baseline, 9 and 18 months.
Measured: 9 months and 18 months
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.
Measured: 9 and 18 months
Quality of life
Patient health related quality of life (HRQOL) using the Health Utilities Index
Measured: 9 and 18 months
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.
Measured: 9 and 18 months
Caregiver self-efficacy
caregiver confidence using a 6-item measure that was utilized in prior care management clinical trials
Measured: 9 months and 18 months
Caregiver unmet need for assistance
a 2-item, 3-point scale for each covering general caregiveing - bathing, dressing, and transportation
Measured: 9 months and 18 months
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).
Measured: 9 months and 18 months
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).
Measured: 9 months and 18 months
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.
Measured: 9 months and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startOct 2009
- Primary completionDec 2011 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Greater Los Angeles Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- University of California, Los Angeles
- Investigators
- Joshua Chodosh, MD, MSHS, Principal investigator, VA / UCLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182987
- Sponsor's protocol ID
- SRC 09-002
- Acronym
- SMPES
- Status last verified
- Aug 2010
- First submitted
- 16 Aug 2010
- Last updated
- 17 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCAN Memory Program Evaluation Study
- ClinicalTrials.gov ID
- NCT01182987
- Acronym / sponsor ID
- SMPES / SRC 09-002
- Conditions
- Dementia
- Keywords
- Quality improvement, Quality of care, Health care utilization, Behavioral change
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- VA Greater Los Angeles Healthcare SystemUS federal agency
- Collaborators
- University of California, Los Angeles
- Study start
- Oct 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 17 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dementia care management | Active comparator | Behavioral: Dementia Care ManagementPatients and family caregivers will be offered dementia care management, which includes detailed comprehensive assessment, education, counseling, referrals to community agencies, collaboration with medical providers and frequent telephone follow-up |
| Usual care | No intervention | –Patients and care family care givers will receive usual support and medical care offered by the health plan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dementia Care ManagementThe 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. | Behavioural | Dementia care management |
Primary outcome
Guideline Adherence
Time frame: 18 months of longer
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.
Program feasibility and fidelity
Time frame: 6 to 18 months
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.
Healthcare utilization
Time frame: 18 months
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.
9 secondary outcomes
Behavioral disturbance
Time frame: 9 months and 18 months
Functional Status
Time frame: 9 and 18 months
Quality of life
Time frame: 9 and 18 months
Quality of Care
Time frame: 9 and 18 months
Caregiver self-efficacy
Time frame: 9 months and 18 months
Caregiver unmet need for assistance
Time frame: 9 months and 18 months
Caregiver social support
Time frame: 9 months and 18 months
Caregiver burden
Time frame: 9 months and 18 months
Caregiver depression
Time frame: 9 months and 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Chodosh, MD, MSHS principal investigator
VA / UCLA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dementia Care Management in people with Dementia, run by VA Greater Los Angeles Healthcare System at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joshua Chodosh, MD, MSHS (310-268-3361, jchodosh@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Guideline Adherence (time frame: 18 months of longer). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2010.