- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07404943
The Effect of Telenursing on Functionality and Treatment Adherence in Bipolar Disorder
The Effect of Telenursing Counseling on Functioning and Treatment Adherence Levels in Individuals With Bipolar Disorder
This research is a randomized controlled experimental study with a pretest-posttest design, conducted to determine the effect of telenursing counseling on functionality and treatment adherence levels in patients with bipolar disorder.
First, patients followed up with a diagnosis of bipolar disorder at the Community Mental Health Center (CMHC) were evaluated by the researcher through face-to-face interviews in terms of the inclusion criteria. Patients who met the criteria and voluntarily agreed to participate in the study were informed about the research, and their written informed consent was obtained. Subsequently, the participants were assigned to the experimental and control groups by an independent faculty member using a stratified block randomization method. Following the randomization process, a nurse working at the Community Mental Health Center administered the Descriptive Information Form, the Short Functioning Assessment Scale, and the Morisky Medication Adherence Scale to both groups face-to-face as a pretest.
After the baseline measurements, an eight-week telenursing counseling intervention was implemented with the patients in the experimental group. No intervention was provided to the control group; they only received standard treatment and care services. At the end of the eight-week period, the same nurse working at the CMHC administered the SFAS and MMAS scales again, and the posttest measurements were obtained.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Kütahya, Turkey (Türkiye), 43040
- Kütahya Evliya Çelebi Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having received a diagnosis of bipolar disorder (Type I/II) at least one year ago according to the diagnostic criteria specified in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR),
- Being followed up at the Community Mental Health Center (CMHC) for at least one year,
- Having a Morisky Medication Adherence Scale score of ≥ 1,
- Having at least a primary school education,
- Owning a mobile phone and having no visual and/or hearing impairment related to calling/messaging use,
- Voluntarily agreeing to participate in the research.
Exclusion Criteria:
- Presence of an acute mood episode,
- Presence of a comorbid mental disorder (e.g., severe personality disorder, substance use disorder),
- Being unable to continue tele-intervention due to a serious physical illness (e.g., cancer, heart failure) and/or cognitive impairment (e.g., loss of intellectual capacity, neurocognitive disorder),
- Presence of conditions that make tele-access impossible,
- Concurrent participation in another psychoeducation or tele-intervention program with similar content.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
group receiving telenursing counseling
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Providing nursing services by telephone is not standard practice in community mental health centers.
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No Intervention: control group
group receiving routine community mental health care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of experimental and control groups and comparison of pre-test and post-test results for Morisky Medication Adherence Scale
Time Frame: From the registration phase to the end of the 8-week telenursing program
|
Morisky Medication Adherence Scale: The scale items are answered as "yes (1 point)" and "no (0 points)".
The total score obtainable from the scale ranges from 0 to 4. Accordingly, a score of 0 indicates high medication adherence, 1-2 points indicate medium adherence, and 3-4 points indicate low adherence.
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From the registration phase to the end of the 8-week telenursing program
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Comparison of experimental and control groups and comparison of pre-test and post-test results for Short Functioning Assessment Scale
Time Frame: From the registration phase to the end of the 8-week telenursing program
|
Short Functioning Assessment Scale (SFAS): The scale consists of 24 items on a four-point Likert scale ("0: no difficulty", "1: minimal difficulty", "2: moderate difficulty", "3: severe difficulty").
SFAS has six subscales: autonomy, occupational functioning, cognitive functioning, financial matters, interpersonal relationships, and leisure activities.
The total score on the scale ranges from 0 to 72, with higher scores indicating poorer functioning.
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From the registration phase to the end of the 8-week telenursing program
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Miklowitz DJ, Efthimiou O, Furukawa TA, Scott J, McLaren R, Geddes JR, Cipriani A. Adjunctive Psychotherapy for Bipolar Disorder: A Systematic Review and Component Network Meta-analysis. JAMA Psychiatry. 2021 Feb 1;78(2):141-150. doi: 10.1001/jamapsychiatry.2020.2993.
- Raesi R, Shaye ZA, Saghari S, Sheikh Beig Goharrizi MA, Raei M, Hushmandi K. The impact of education through nurse-led telephone follow-up (telenursing) on the quality of life of COVID-19 patients. J Egypt Public Health Assoc. 2021 Nov 8;96(1):30. doi: 10.1186/s42506-021-00093-y.
- Oz HS, Ayhan D, Oz F. Effects of Telenursing on Drug Attitudes, Self-Efficacy, and Quality of Life in Individuals With Schizophrenia: A Randomized Controlled Trial. J Psychosoc Nurs Ment Health Serv. 2024 Oct;62(10):15-24. doi: 10.3928/02793695-20240423-02. Epub 2024 May 6.
- Van der Walt JP, Scott DB. Bullera dendrophila sp. n. Antonie Van Leeuwenhoek. 1970;36(3):383-7. doi: 10.1007/BF02069038. No abstract available.
- Nierenberg AA, Agustini B, Kohler-Forsberg O, Cusin C, Katz D, Sylvia LG, Peters A, Berk M. Diagnosis and Treatment of Bipolar Disorder: A Review. JAMA. 2023 Oct 10;330(14):1370-1380. doi: 10.1001/jama.2023.18588.
- Najafi SS, Shaabani M, Momennassab M, Aghasadeghi K. The Nurse-Led Telephone Follow-Up on Medication and Dietary Adherence among Patients after Myocardial Infarction: A Randomized Controlled Clinical Trial. Int J Community Based Nurs Midwifery. 2016 Jul;4(3):199-208.
- Miller JN, Black DW. Bipolar Disorder and Suicide: a Review. Curr Psychiatry Rep. 2020 Jan 18;22(2):6. doi: 10.1007/s11920-020-1130-0.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Bipolar and Related Disorders
- Mental Disorders
- Mood Disorders
- Behavior
- Health Behavior
- Bipolar Disorder
- Treatment Adherence and Compliance
- Professional Practice
- Organization and Administration
- Health Services Administration
- Delivery of Health Care
- Telemedicine
- Patient Care Management
- Nursing
- Telenursing
Other Study ID Numbers
- 2024-257
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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