Quality of LifeNCT04393987
Effect Of Treatment Compliance Training Given To Patients With Bipolar Disorder
A study testing Treatment Compliance Training in people with Quality of Life and Treatment Compliance, run by Uşak University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Quality of Life, Treatment Compliance
- What is being tested?
- Treatment Compliance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2018to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteering to participate,
- Being diagnosed with bipolar disorder,
- Being in the euthymic period,
- Being at the age of 18 or over,
- Being literate.
Who cannot join
- Being in an acute period of exacerbation
- Actively using alcohol or psychoactive substances
- Having another psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Quality of Life, Treatment Compliance
- Being tested
- Treatment Compliance Training
- Keywords
- bipolar disorder, Treatment Compliance Training, Quality of Life, Social Functioning
- Medical subject headings
- Patient Compliance, Bipolar Disorder, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment Compliance TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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 .
Measured: Change from baseline to 5 weeks (also assessed at 17 weeks post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start15 Sep 2018
- Primary completion1 Jan 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ebru başkaya, Uşak University
- Investigators
- Ebru Başkaya, PhD, Principal investigator, Uşak University Vocational School of Health Services 64000 Uşak / Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393987
- Sponsor's protocol ID
- Ebaskaya
- Status last verified
- May 2020
- First submitted
- 14 May 2020
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Treatment Compliance Training Given To Patients With Bipolar Disorder On Treatment Compliance, Social Functioning, And Quality Of Life
- ClinicalTrials.gov ID
- NCT04393987
- Acronym / sponsor ID
- Ebaskaya
- Conditions
- Quality of Life, Treatment Compliance
- Keywords
- bipolar disorder, Treatment Compliance Training, Quality of Life, Social Functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arms | Experimental | Behavioral: Treatment Compliance TrainingTreatment 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Volunteering to participate,
- Being diagnosed with bipolar disorder,
- Being in the euthymic period,
- Being at the age of 18 or over,
- Being literate.
Key exclusion criteria (3 listed)
- Being in an acute period of exacerbation
- Actively using alcohol or psychoactive substances
- Having another psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment Compliance TrainingTreatment 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. | Behavioural | Arms |
Primary outcome
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).
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.
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 .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebru Başkaya, PhD principal investigator
Uşak University Vocational School of Health Services 64000 Uşak / Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment Compliance Training in people with Quality of Life and Treatment Compliance, run by Uşak University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence Rating Scale (MARS) (time frame: Change from baseline to 5 weeks (also assessed at 17 weeks post-baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020.