The Effect of Telenursing on Functionality and Treatment Adherence in Bipolar Disorder

NCT07404943 | Completed

• 1 other identifier: 2024-257
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bi-Polar Disorder

Keywords

bi-polar; Treatment Adherence; Functioning; telenursing

Outcome Measures

Primary Outcomes (2)

• Comparison of experimental and control groups and comparison of pre-test and post-test results for Morisky Medication Adherence Scale

  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.

  From the registration phase to the end of the 8-week telenursing program

• Comparison of experimental and control groups and comparison of pre-test and post-test results for Short Functioning Assessment Scale

  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.

  From the registration phase to the end of the 8-week telenursing program

Study Arms (2)

experimental group

EXPERIMENTAL

group receiving telenursing counseling

Behavioral: telenursing

control group

NO INTERVENTION

group receiving routine community mental health care

Interventions

telenursing BEHAVIORAL

Providing nursing services by telephone is not standard practice in community mental health centers.

experimental group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Didem Ayhan: lead

Study Sites (1)

Kütahya Evliya Çelebi Training and Research Hospital

Kütahya, 43040, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 34748085 BACKGROUND

• 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.

  PMID: 38709104 BACKGROUND

• 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.

  PMID: 5312514 BACKGROUND

• 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.

  PMID: 37815563 BACKGROUND

• 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.

  PMID: 27382586 BACKGROUND

• 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.

  PMID: 31955273 BACKGROUND

• 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.

  PMID: 33052390 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder; Treatment Adherence and Compliance

Interventions

Telenursing

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Nursing; Professional Practice; Organization and Administration; Health Services Administration; Telemedicine; Delivery of Health Care; Patient Care Management

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc. prof

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: February 12, 2026
• Study Start: December 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)