Milestones of Adjustment Post-Psychosis (MAPP)
|ClinicalTrials.gov Identifier: NCT01192594|
Recruitment Status : Terminated
First Posted : September 1, 2010
Last Update Posted : September 8, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Quality of Life Adjustment, Psychological Medication Adherence Signs and Symptoms||Behavioral: Training in all modules including MAPP Recovery Model Behavioral: Training in all modules except MAPP Recovery Model||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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 Start Date :||November 2009|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Experimental: MAPP Trained Case Managers
Consumers assigned to case managers who receive training in the Milestones of Adjustment Post-Psychosis Recovery Model
Behavioral: Training in all modules including MAPP Recovery Model
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.
Active Comparator: Non-MAPP trained case managers
Consumers of case managers not trained in the Milestones of Adjustment Post-Psychosis Recovery Model
Behavioral: Training in all modules except MAPP Recovery Model
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.
- Medication Adherence [ Time Frame: Two years ]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.
- Psychological Adjustment Post-Psychosis [ Time Frame: 2 years ]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 [ Time Frame: 2 years ]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 [ Time Frame: 2 years ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01192594
|United States, Connecticut|
|The Connection Inc|
|New Haven, Connecticut, United States, 06511|
|Principal Investigator:||Mary D Moller, DNP||Yale University School of Nursing|