Effect Of Treatment Compliance Training Given To Patients With Bipolar Disorder

Sponsor

Uşak University (Other)

Overall Status

Completed

CT.gov ID

NCT04393987

Collaborator

(none)

Enrollment

Location

Arms

11.5

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Quality of Life Treatment Compliance	Behavioral: Treatment Compliance Training	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 15, 2018

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Sep 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.
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.

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uşak Üniversity	Uşak		Turkey	64000

Sponsors and Collaborators

Uşak University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ebru başkaya, Principal Investigator, Uşak University

ClinicalTrials.gov Identifier:

NCT04393987

Other Study ID Numbers:

Ebaskaya

First Posted:

May 19, 2020

Last Update Posted:

May 20, 2020

Last Verified:

May 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by ebru başkaya, Principal Investigator, Uşak University

bipolar disorder

Treatment Compliance Training

Quality of Life

Social Functioning

Additional relevant MeSH terms:

Bipolar Disorder

Study Results

No Results Posted as of May 20, 2020