Clinical trial NCT01192594: Milestones of Adjustment Post-Psychosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Schizophrenia
Quality of Life
Adjustment, Psychological
Medication Adherence
Signs and Symptoms
Keywords: symptom management
empowerment
medication adherence
recovery
schizophrenia
post-psychotic adjustment process
psychological adjustment
psychiatric case managers
psychosis
insight
cognitive function
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2010-09-01
Enrollment: 110
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Medication Adherence
timeFrame: Two years
Secondary outcomes:
measure: Psychological Adjustment Post-Psychosis
timeFrame: 2 years
measure: Quality of Life
timeFrame: 2 years
measure: Symptom Management
timeFrame: 2 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: The Connection Inc
state: Connecticut
Study officials:
affiliation: Yale University School of Nursing
name: Mary D Moller, DNP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moller, M.D. (2009). Neurobiological responses and schizophrenia and psychotic disorders. In, Stuart, G. Principles and practices of psychiatric nursing, 9th Ed. Chapter 20/ St. Louis: Mosby.