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Effectiveness of Adherence Therapy for Schizophrenia

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by The Hong Kong Polytechnic University
Sponsor:
Collaborators:
Castle Peak Hospital, Hong Kong
Kwai Chung Hospital, Hong Kong
Information provided by (Responsible Party):
Chien Wai-Tong, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT01780116
First received: January 29, 2013
Last updated: July 6, 2014
Last verified: July 2014
  Purpose

When compared with those in the control (usual care) group, participants in the AT group are expected to demonstrate significant improvements immediately and at three, six and 12 months after completion of the intervention in: level of medication adherence, readmission rate, mental status, insight into treatment, and level of functioning.


Condition Intervention Phase
Schizophrenia
Schizophreniform Disorder
Schizoaffective Disorder
Behavioral: Adherence therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: An Evaluation of the Effectiveness of Adherence Therapy for Schizophrenia: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by The Hong Kong Polytechnic University:

Primary Outcome Measures:
  • re-hospitalization rate [ Time Frame: 12 months after completion of intervention ] [ Designated as safety issue: No ]
    rate and length of psychiatric hospital readmission immediately, 6 months and 12 months after the completion of the intervention undertaken


Secondary Outcome Measures:
  • level of medication adherence [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
    level of adherence to antipsychotic medication measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention

  • mental status [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
    symptom severity measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention

  • insight into treatment [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
    insights into illness and treatment measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention

  • functioning [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
    level of functioning measured at recruitment and at immediately, 6 months and 12 months after completion fo the intervention


Other Outcome Measures:
  • program attendance and attrition [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
    attendance and attrition rate


Estimated Enrollment: 134
Study Start Date: May 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Medicaiton adherence therapy

Adherence therapy, consisting of six, 2-hour sessions over 3 months, in three phases:

  1. Engaging patients: assessing needs and concerns in medication adherence;
  2. Reviewing strengths and barriers and developing coping strategies; and
  3. Rationalizing beliefs and concerns and preventing relapse.
Behavioral: Adherence therapy
Systematic and highly structured medication adherence program using the motivational interviewing (MI) technique that focuses on six principles: expressing empathy, developing discrepancy between client's beliefs and evidence, supporting self-efficacy, avoiding argumentation, and rolling with resistance to behavioral change. MI is often able (with in-depth behavioral analysis) to focus on particular consequences of problem behavior, such as medication non-adherence, that have an obvious impact on patients.
Other Name: Medication adherence program
No Intervention: Routine community care
Routine Community psychiatric nursing services provided by the Community Psychiatric Nurses in the practice field

Detailed Description:

When compared with those in the control (usual care) group, participants in the AT group are expected to demonstrate significant improvements immediately and at three, six and 12 months after completion of the intervention in the following aspects:

  1. level of adherence to antipsychotic medication,
  2. rate and length of psychiatric hospital readmission,
  3. mental status,
  4. insight and attitude into illness and treatment, and
  5. level of functioning.

The primary outcomes are level of antipsychotic medication adherence, re-hospitalization rates and mental status; and the patients' drug attitude will be the mediating factor of the AT.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria of the patients include those who:

  • are Hong Kong Chinese residents;
  • have a primary diagnosis of schizophrenia or its subtypes such as schizophreniform and schizoaffective disorders not more than 3 years;
  • have been prescribed oral antipsychotics for at least 1 month;
  • are aged 18-65 years;
  • have Positive and Negative Syndrome Scale (PANSS) score >60 and are judged by the case Community Psychiatric Nurse/psychiatrist as non-adherents; and
  • are able to understand Cantonese/Mandarin.

Patients will be excluded if they have:

  • only depot/intramuscular injections as regular psychiatric medication;
  • co-morbidity of learning disability and organic brain disease, or clinically significant medical diseases;
  • participated in adherence therapy; and/or
  • visual, language or communication difficulty.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780116

Contacts
Contact: Wai Tong Chien, PhD 852-2766 5648 wai.tong.chien@polyu.edu.hk
Contact: Jolene Mui, MSc 852-2456 8487 muihc@ha.org.hk

Locations
Hong Kong
Kwai Chung Hospital Recruiting
Kwai Chung, NT, Hong Kong
Contact: WT Chien, PhD    852-2766 5648    wai.tong.chien@polyu.edu.hk   
Contact: Glendy Ip, MSc    852-2959 8463    ipsh@ha.org.hk   
Sub-Investigator: Glendy Ip, MSc         
Castle Peak Hospital Recruiting
Tuen Mun, NT, Hong Kong
Contact: Jolene Mui, MSc    852-24568487    muihc@ha.org.hk   
Contact: Alan Chan, BSc    852-6594 3964    rsalanc@polyu.edu.hk   
Sub-Investigator: Eric Cheung, MD         
Sub-Investigator: Jolene Mui, MSc         
Sponsors and Collaborators
The Hong Kong Polytechnic University
Castle Peak Hospital, Hong Kong
Kwai Chung Hospital, Hong Kong
Investigators
Principal Investigator: WT Chien, PhD The Hogn Kong Polytechnic University
  More Information

Publications:
1. Chien, W.T., Mui, J., Cheung, E., & Gray, R. (2013). Effectiveness of medication adherence therapy for schizophrenia: A randomized controlled trial. Presentation (Book of Abstracts, pp. 144-146) at the 19th International Network for Psychiatric Nursing Research, 'The Personal and Political of Mental Health Nursing Research' (5-6 September 2013), Warwick Conference Centre, Coventry, UK. London: Royal College of Nursing.

Responsible Party: Chien Wai-Tong, Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT01780116     History of Changes
Other Study ID Numbers: AT-2013
Study First Received: January 29, 2013
Last Updated: July 6, 2014
Health Authority: Hong Kong: Health and Medical Research Fund, Food & Health Bureau

Keywords provided by The Hong Kong Polytechnic University:
schizophrenia
adherence therapy
medication
randomized controlled trial
cost-effectiveness

Additional relevant MeSH terms:
Disease
Psychotic Disorders
Schizophrenia
Mental Disorders
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 19, 2014