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Effect Of Treatment Compliance Training Given To Patients With Bipolar Disorder

Primary Purpose

Quality of Life, Treatment Compliance

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Treatment Compliance Training
Sponsored by
Uşak University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quality of Life focused on measuring bipolar disorder, Treatment Compliance Training, Quality of Life, Social Functioning

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Uşak Üniversity

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arms

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Medication Adherence Rating Scale (MARS)
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).
Social Functioning Scale (SFS)
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.
World Health Organization Quality of Life Instrument Short Form (WHOQOLBREF-TR)
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 .

Secondary Outcome Measures

Full Information

First Posted
May 14, 2020
Last Updated
May 18, 2020
Sponsor
Uşak University
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1. Study Identification

Unique Protocol Identification Number
NCT04393987
Brief Title
Effect Of Treatment Compliance Training Given To Patients With Bipolar Disorder
Official Title
Effect Of Treatment Compliance Training Given To Patients With Bipolar Disorder On Treatment Compliance, Social Functioning, And Quality Of Life
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 15, 2018 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uşak University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Treatment Compliance
Keywords
bipolar disorder, Treatment Compliance Training, Quality of Life, Social Functioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The research was using quasi-experimentally research methods. The research was carried out with 19 patients enrolled in the Community Mental Health Center and 21 outpatients who were monitored in the Psychiatry Outpatient Clinic of a university and who met the inclusion criteria. The data were collected using the Participant Information Form, Medication Adherence Rating Scale, Social Functioning Scale, and World Health Organization Quality of Life Instrument Short Form. Treatment compliance training was given to the intervention group (n=19) individually once a week for a total of five sessions. No intervention was applied to the control group (n=21) following the pretest application. Post-tests were applied to the intervention group after the training and follow-up tests were applied to both groups three months after the training.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arms
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment Compliance Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medication Adherence Rating Scale (MARS)
Description
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).
Time Frame
Change from baseline to 5 weeks (also assessed at 17 weeks post-baseline)
Title
Social Functioning Scale (SFS)
Description
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.
Time Frame
Change from baseline to 5 weeks (also assessed at 17 weeks post-baseline)
Title
World Health Organization Quality of Life Instrument Short Form (WHOQOLBREF-TR)
Description
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 .
Time Frame
Change from baseline to 5 weeks (also assessed at 17 weeks post-baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebru Başkaya, PhD
Organizational Affiliation
Uşak University Vocational School of Health Services 64000 Uşak / Turkey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uşak Üniversity
City
Uşak
ZIP/Postal Code
64000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Effect Of Treatment Compliance Training Given To Patients With Bipolar Disorder

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