Outcomes of Psychiatric Case Manager Training on Medication Adherence, Progression Through the Four Phases of the MAPP Recovery Model, and Quality of Life in Patients With Schizophrenia
| City: |
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New Haven |
| State: |
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Connecticut |
| Zip Code: |
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06511 |
| Conditions: |
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Schizophrenia - Quality of Life - Adjustment, Psychological - Medication Adherence - Signs and Symptoms |
| Purpose: |
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This nested design clinical outcome study of psychiatric case manager education on disease
state, psychopharmacology of schizophrenia, relapse, motivational interviewing, and the
process of psychological adjustment post-psychosis (Milestones of Adjustment Post-Psychosis
Recovery Model-MAPP) will test the following hypotheses:
1. Medication non-adherence in patients with schizophrenia assigned to case managers who
receive MAPP training will decrease from their pre-study rate and from the reported
national average after one year enrollment compared to consumers not enrolled in the
MAPP arm of the study.
2. Consumers in the MAPP intervention will have higher Quality of Life Enjoyment and
Satisfaction Questionnaire (Q-Les-Q (53) scores than consumers not enrolled in the MAPP
at quarterly measures.
3. Consumers enrolled in the MAPP intervention arm of the study will successfully complete
the first two phases of the MAPP Recovery Model in one year.
4. Consumers in the MAPP intervention arm will have greater symptom reductions at
quarterly data points compared to consumers not enrolled in the MAPP intervention arm.
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| Study Summary: |
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52 psychiatric case managers will receive manualized training in the disease state of
schizophrenia, psychotropic medications, motivational interviewing, and relapse prevention.
After randomization, 26 case managers will receive additional manualized training in the
process of post-psychotic adjustment. Outcomes of 130 consumers (5 per case manager)
related to medication adherence, relapse rates, symptom intensity, and quality of life will
be evaluated at quarterly intervals over a two-year period. Outcomes of 130 consumers
related to medication adherence, relapse rates, symptom intensity, quality of life, and
progression through the phases of postpsychotic adjustment (MAPP-Milestones of Adjustment
Post-Psychosis Recovery Model) will be evaluated at quarterly intervals via rating scales
over a two-year period and the two groups compared.
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| Criteria: |
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Inclusion Criteria:Case Managers
- Voluntary basis-includes willingness to administer study tools quarterly for two
years to at least five consumers from their assigned caseloads and to keep a log of
their activities and reactions.
Inclusion Criteria for consumer subjects: 130 in each treatment arm
1. A diagnosis of a schizophrenia spectrum disorder as defined by DSMIV TR (63)
2. Males and females at least 21 years of age assigned to case managers
3. Able to understand the requirements of the study
Exclusion Criteria:Case Managers
- None, all case managers are eligible for the study
Exclusion Criteria: Consumers
- Any DSM-IV Axis I disorder not defined in the inclusion criteria
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| NCT ID: |
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NCT01192594 |
| Primary Contact: |
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Principal Investigator
Mary D Moller, DNP
Yale University School of Nursing
Mary D Moller, DNP
Phone: 203-737-1791
Email: mary.moller@yale.edu
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| Backup Contact: |
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Email: callie.fentress@yale.edu
Callie Fentress, BA
Phone: 508-264-3155
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| Location Contact: |
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New Haven, Connecticut 06511
United States
Jenifer Blemings, MS
Phone: 203-776-9900
Email: jblemings@theconnectioninc.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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