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Bi-Polar DisorderNCT07404943

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

A study testing telenursing in people with Bi-Polar Disorder, run by Didem Ayhan at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bi-Polar Disorder
What is being tested?
telenursing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2024to 1 Dec 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Kütahya Evliya Çelebi Training and Research Hospital

    Kütahya, 43040

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Being tested
telenursing
Keywords
bi-polar, Treatment Adherence, Functioning, telenursing
Medical subject headings
Bipolar Disorder, Treatment Adherence and Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • telenursingBehavioural

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

Study groups in NCT07404943
Study groupRoleWhat they receive
experimental groupExperimentalgroup receiving telenursing counseling
Receives: Behavioral: telenursing
control groupNo interventiongroup receiving routine community mental health care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2026
  2. Study start1 Dec 2024
  3. Primary completion1 Sep 2025
  4. Study completion1 Dec 2025

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07404943
Sponsor's protocol ID
2024-257
Status last verified
Jan 2026
First submitted
24 Jan 2026
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual assessments will not be conducted; analyses will be based on the total number.

Publications

  • 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.

    PubMed 34748085

  • 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.

    PubMed 38709104

  • 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.

    PubMed 5312514

  • 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.

    PubMed 37815563

  • 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.

    PubMed 27382586

  • 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.

    PubMed 31955273

  • 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.

    PubMed 33052390

  • Ubic N, Ayhan D. The effect of tele-nursing counseling on functioning and medication adherence in individuals with bipolar disorder: A randomized controlled trial. Arch Psychiatr Nurs. 2026 Oct;64:152217. doi: 10.1016/j.apnu.2026.152217. Epub 2026 Aug 13.

    PubMed 42863911

Questions about this trial

What is this clinical trial studying?

A study testing telenursing in people with Bi-Polar Disorder, run by Didem Ayhan 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 6 inclusion and 5 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 31 Jul 2026. 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?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07404943, which also lists 8 linked publications.

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 31 Jul 2026.

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