Effect Of Treatment Compliance Training Given To Patients With Bipolar Disorder

May 18, 2020 updated by: ebru başkaya, Uşak University

Effect Of Treatment Compliance Training Given To Patients With Bipolar Disorder On Treatment Compliance, Social Functioning, And Quality Of Life

In bipolar disorder, treatment noncompliance is associated with high rates of recurrence and hospitalization. Furthermore, it is reported that that treatment noncompliance disturbs the social functioning of patients and reduces the quality of life. Improvement of the quality of life, social functioning and treatment compliance is as important as the long-term treatment of symptoms.This study aimed to determine the effect of treatment compliance training given to patients with bipolar disorder on treatment compliance, social functioning, and quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim is to determine the effect of treatment compliance training given to patients with bipolar disorder on treatment compliance, social functioning, and quality of life.

The study was conducted with 38 bipolar disorder (n=17 intervention group; n=21 control group) using a quasi-experimental research design. Patients were evaluated using a pre-test, post-test, monitoring test, "Medication

Adherence Rating Scale (MARS)", "Social Functioning Scale (SFS)", and "World Health Organization Quality of Life Instrument Short Form (WHOQOLBREF-TR)." The measurements were taken 3 times:

pre test, post-test and 3-months post-test.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Uşak, Turkey, 64000
        • Uşak University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Volunteering to participate,
  • Being diagnosed with bipolar disorder,
  • Being in the euthymic period,
  • Being at the age of 18 or over,
  • Being literate.

Exclusion Criteria:

  • Being in an acute period of exacerbation
  • Actively using alcohol or psychoactive substances
  • Having another psychiatric illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
No intervention was performed on the patients in the control group, and routine follow-up (arranging treatment by the doctor, answering the patient's and family's questions about treatment) continued in the polyclinic.
Experimental: Arms
Treatment Compliance Training The treatment compliance training consists of five sessions in total and was given individually. Each session of the treatment compliance training given once a week took 45 minutes on average.
Behavioral: Treatment Compliance Training
Treatment Compliance Training consist of: Introduction of Treatment Compliance Program and Information about the Disease, Therapies for Bipolar Disorder and Importance of Treatment Compliance, Drugs Used for Bipolar Disorder, Effects and Side effects, Strategies to Solve Treatment-Related Problems and Cope with Stress, Beliefs, Attitudes, and Stigmatization Towards Patient/Disease in Bipolar Disorder. The sessions were held in the form of PowerPoint presentations. In the Treatment Compliance Training, lecture, question-answer, homework, sharing experiences, video presentation, summarization were used.The day before each session, patients were phoned and reminded of the time of the session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication Adherence Rating Scale (MARS)
Time Frame: Change from baseline to 5 weeks (also assessed at 17 weeks post-baseline)
The scale assesses the patient's compliance behaviors and attitude to treatment. The scale consists of 10 questions to answer in the form of Yes/No (between 1-7 were poor in compliance with treatment and those with scores between 8-10 were high). The scale assesses the patient's compliance behaviors and attitude to treatment. The scale consists of 10 questions to answer in the form of Yes/No (between 1-7 were poor in compliance with treatment and those with scores between 8-10 were high).
Change from baseline to 5 weeks (also assessed at 17 weeks post-baseline)
Social Functioning Scale (SFS)
Time Frame: Change from baseline to 5 weeks (also assessed at 17 weeks post-baseline)
The Social Functioning Scale is a tool that evaluates role functions requiring judgment on the social role of an individual. The scale consists of seven subscales. The total score that can be obtained from this scale ranges between 0-223 points. High scores taken from each subscale indicate that there is a positive development in functioning.
Change from baseline to 5 weeks (also assessed at 17 weeks post-baseline)
World Health Organization Quality of Life Instrument Short Form (WHOQOLBREF-TR)
Time Frame: Change from baseline to 5 weeks (also assessed at 17 weeks post-baseline)
World Health Organization Quality of Life Instrument Short Form consists of 26 questions and four domains. These 4 domains are physical health, psychological health, social relationships, and environment.Domain I: Physical domain: It covers the ability to conduct daily tasks, commitment to medicines and treatment, vitality and fatigue, physical mobility, pain and discomfort, sleep and rest, ability to work. Domain II: Mental domain: It covers body image and appearance, negative emotions, memory, and concentration. Domain III: Social domain: It covers the relationships with others, social support, and sexual life. Domain IV: Environmental domain: It covers financial resources, physical security, access to health services, home environment, opportunity for rest and recreation, physical environment and transportation. The quality of life increases as the score obtained from the domains increases .
Change from baseline to 5 weeks (also assessed at 17 weeks post-baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uşak University

Investigators

  • Principal Investigator: Ebru Başkaya, PhD, Uşak University Vocational School of Health Services 64000 Uşak / Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2018

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

May 14, 2020

First Submitted That Met QC Criteria

May 14, 2020

First Posted (Actual)

May 19, 2020

Study Record Updates

Last Update Posted (Actual)

May 20, 2020

Last Update Submitted That Met QC Criteria

May 18, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ebaskaya

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Other researchers will be able to read detailed information such as the research method and results when the research is published. The "Research Protocol" will be available on the this PRS page.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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