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Milestones of Adjustment Post-Psychosis (MAPP)

Primary Purpose

Schizophrenia, Quality of Life, Adjustment, Psychological

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Training in all modules including MAPP Recovery Model
Training in all modules except MAPP Recovery Model
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Schizophrenia focused on measuring symptom management, empowerment, medication adherence, recovery, schizophrenia, post-psychotic adjustment process, psychological adjustment, psychiatric case managers, psychosis, insight, cognitive function

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Connection Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MAPP Trained Case Managers

Non-MAPP trained case managers

Arm Description

Consumers assigned to case managers who receive training in the Milestones of Adjustment Post-Psychosis Recovery Model

Consumers of case managers not trained in the Milestones of Adjustment Post-Psychosis Recovery Model

Outcomes

Primary Outcome Measures

Medication Adherence
Specific consumer medication adherence outcome data will be collected quarterly for both groups for two years targeting two specific analyses of change: pharmacy records of prescription refills one year before and quarterly after the educational intervention. These records will be obtained by informed consent from the consumer and respective pharmacies.

Secondary Outcome Measures

Psychological Adjustment Post-Psychosis
Movement through the four phases of the MAPP: cognitive dissonance, insight, cognitive constancy, and ordinariness and resolution of stage specific themes will be evaluated quarterly for both years of the study and analyzed using latent transitional analysis
Quality of Life
The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-Les-Q) will be administered quarterly to consumers in both arms of the study over two years.
Symptom Management
Symptoms associated with anxiety, depression, psychosis, mania,cognitive difficulties, activities of daily living, medication adherence, interpersonal relationships, general health concerns, and common symptom management strategies will be measured quarterly using the Moller-Murphy Symptom Management Assessment Tool

Full Information

First Posted
August 30, 2010
Last Updated
September 6, 2016
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT01192594
Brief Title
Milestones of Adjustment Post-Psychosis
Acronym
MAPP
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

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Study Start Date
November 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MAPP Trained Case Managers
Arm Type
Experimental
Arm Description
Consumers assigned to case managers who receive training in the Milestones of Adjustment Post-Psychosis Recovery Model
Arm Title
Non-MAPP trained case managers
Arm Type
Active Comparator
Arm Description
Consumers of case managers not trained in the Milestones of Adjustment Post-Psychosis Recovery Model
Intervention Type
Behavioral
Intervention Name(s)
Training in all modules including MAPP Recovery Model
Intervention Description
50% of the case managers will complete all five modules: Disease state,psychopharmacology,symptom management, motivational interviewing and adherence, and the Milestones of Adjustment Post-Psychosis Recovery Model including the MAPP treatment guide.
Intervention Type
Behavioral
Intervention Name(s)
Training in all modules except MAPP Recovery Model
Intervention Description
50% of the case managers in the study will complete only four training modules: Disease state, psychopharmacology, symptom management, and motivational interviewing and adherence. They will not complete the Milestones of Adjustment Post-Psychosis Recovery Model module.
Primary Outcome Measure Information:
Title
Medication Adherence
Description
Specific consumer medication adherence outcome data will be collected quarterly for both groups for two years targeting two specific analyses of change: pharmacy records of prescription refills one year before and quarterly after the educational intervention. These records will be obtained by informed consent from the consumer and respective pharmacies.
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Psychological Adjustment Post-Psychosis
Description
Movement through the four phases of the MAPP: cognitive dissonance, insight, cognitive constancy, and ordinariness and resolution of stage specific themes will be evaluated quarterly for both years of the study and analyzed using latent transitional analysis
Time Frame
2 years
Title
Quality of Life
Description
The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-Les-Q) will be administered quarterly to consumers in both arms of the study over two years.
Time Frame
2 years
Title
Symptom Management
Description
Symptoms associated with anxiety, depression, psychosis, mania,cognitive difficulties, activities of daily living, medication adherence, interpersonal relationships, general health concerns, and common symptom management strategies will be measured quarterly using the Moller-Murphy Symptom Management Assessment Tool
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 A diagnosis of a schizophrenia spectrum disorder as defined by DSMIV TR (63) Males and females at least 21 years of age assigned to case managers 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary D Moller, DNP
Organizational Affiliation
Yale University School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Connection Inc
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States

12. IPD Sharing Statement

Citations:
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.
Results Reference
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