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Completed

NCT Number: NCT07404943

The Effect of Telenursing on Functionality and Treatment Adherence in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kütahya Evliya Çelebi Training and Research Hospital

Kütahya, 43040, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

telenursing

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Didem Ayhan

Other

Registry information

Official study title

The Effect of Telenursing Counseling on Functioning and Treatment Adherence Levels in Individuals With Bipolar Disorder

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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