Milestones of Adjustment Post-Psychosis

NCT01192594 | Terminated Phase 3 DMC

• 1 other identifier: 0906005268
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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. 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. 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. 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Two years

Secondary Outcomes (3)

• Psychological Adjustment Post-Psychosis

  2 years

• Quality of Life

  2 years

• Symptom Management

  2 years

Study Arms (2)

MAPP Trained Case Managers

EXPERIMENTAL

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

Non-MAPP trained case managers

ACTIVE COMPARATOR

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

Behavioral: Training in all modules except MAPP Recovery Model

Interventions

Training in all modules including MAPP Recovery Model BEHAVIORAL

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.

MAPP Trained Case Managers

Training in all modules except MAPP Recovery Model BEHAVIORAL

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.

Non-MAPP trained case managers

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• None, all case managers are eligible for the study

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

The Connection Inc

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Medication Adherence; Signs and Symptoms; Empowerment; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Pathological Conditions, Signs and Symptoms; Social Behavior

Study Officials

• Mary D Moller, DNP

  Yale University School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: September 1, 2010
• Study Start: November 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: September 8, 2016

Record last verified: 2016-09

Locations

US (1)