Effect Of Treatment Compliance Training Given To Patients With Bipolar Disorder

NCT04393987 | Completed

• 1 other identifier: Ebaskaya
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Treatment Compliance

Keywords

bipolar disorder; Treatment Compliance Training; Quality of Life; Social Functioning

Outcome Measures

Primary Outcomes (3)

• 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).

  Change from baseline to 5 weeks (also assessed at 17 weeks post-baseline)

• 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.

  Change from baseline to 5 weeks (also assessed at 17 weeks post-baseline)

• 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 .

  Change from baseline to 5 weeks (also assessed at 17 weeks post-baseline)

Study Arms (2)

Arms

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Treatment Compliance Training BEHAVIORAL

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.

Arms

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Uşak University: lead

Study Sites (1)

Uşak Üniversity

Uşak, 64000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient Compliance; Bipolar Disorder; Social Adjustment

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Social Behavior

Study Officials

• Ebru Başkaya, PhD

  Uşak University Vocational School of Health Services 64000 Uşak / Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 19, 2020
• Study Start: September 15, 2018
• Primary Completion: January 1, 2019
• Study Completion: September 1, 2019
• Last Updated: May 20, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)