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Clinical Trials/NCT07404943
NCT07404943CompletedNot Applicable

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

Didem Ayhan1 site in 1 country70 target enrollmentStarted: December 1, 2024Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
70
Locations
1
Primary Endpoint
Comparison of experimental and control groups and comparison of pre-test and post-test results for Morisky Medication Adherence Scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

experimental group

Experimental

group receiving telenursing counseling

Intervention: telenursing (Behavioral)

control group

No Intervention

group receiving routine community mental health care

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Didem Ayhan
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Didem Ayhan

Assoc. prof

Bandırma Onyedi Eylül University

Study Sites (1)

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