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Type2 DiabetesNCT05628259

The Effect of Tele-Nursing Based Motivational Interviewing in Individuals With Type 2 Diabetes:RCT

A study testing Tele-Nursing based Motivational Interviewing in people with Type2 Diabetes and Self Efficacy, run by Pamukkale University at 3 sites 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 study carried out to examine the effect of tele-nursing based motivational interviewing on diabetes self-efficacy, diabetes self-management and metabolic control parameters (Body mass index, waist circumference, HbA1c%,fasting blood glucose, LDL cholesterol, HDL cholesterol, total cholesterol, triglyceride) in… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type2 Diabetes, Self Efficacy, Self Management
What is being tested?
Tele-Nursing based Motivational Interviewing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
3 sitesTurkey (Türkiye)
Study dates
1 Feb 2023to 2 Oct 2023
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

  • 1) being over 18 years old, 2) receiving insulin or insulin + oral therapy, 3) diagnosis of type 2 diabetes at least one year ago, 4) having a BMI of 25 and above, 5) HbA1c value of 7 and above, 6) access to phone, 7) voluntarily agreeing to participate in the study.

Who cannot join

  • 1) have a physical disability.

Trial locations and contacts

3 sites in 1 country.

Turkey (Türkiye)3 sites

  • İrem Nur ÖZDEMİR

    Istanbul

  • Şengül AYDIN YOLDEMİR

    Istanbul

  • Eda Kılınç İşleyen

    Pamukkale, Denizli, (545)-561 96 83

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Tele-Nursing Based Motivational Interviewing on Diabetes Self-Efficacy, Diabetes Self-Management and Metabolic Control Parameters in Individuals With Type 2 Diabetes: Randomized Controlled Study

This study carried out to examine the effect of tele-nursing based motivational interviewing on diabetes self-efficacy, diabetes self-management and metabolic control parameters (Body mass index, waist circumference, HbA1c%,fasting blood glucose, LDL cholesterol, HDL cholesterol, total cholesterol, triglyceride) in individuals with type 2 diabetes.

Read the detailed description

The first researcher of the article who applied Motivational Interviewing Techniques has a "Motivational Interviewing Techniques Training" certificate. A motivational interview (MI) program based on the telenursing approach was prepared by the researchers based on the literature for the individuals in the experimental group. In this study, the MI procedure includes eight sessions in total, with four sessions of motivational interviews by phone in the first month of the intervention and four sessions of motivational interviews by phone in the next two months for each individual. Pre-tests were collected in the first month. Afterwards, MI intervention was applied for three months. This intervention was applied to the experimental group in addition to the routine care provided by the hospital. MI application took an average of 45-60 minutes via phone call.

Being tested
Tele-Nursing based Motivational Interviewing
Medical subject headings
Hyperlipoproteinemia Type II, Hypoalphalipoproteinemias, Lipidoses

What participants receive

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

  • Tele-Nursing based Motivational InterviewingBehavioural

    A motivational interview (MI) program based on the telenursing approach was applied to the individuals in the experimental group. In this study, the MI procedure includes eight sessions in total, with four sessions of motivational interviews by phone in the first month of the intervention and four sessions of motivational interviews by phone in the next two months for each individual. Pre-tests were collected in the first month. Afterwards, MI intervention was applied for three months. This intervention was applied to the experimental group in addition to the routine care provided by the hospital. MI application took an average of 45-60 minutes via phone call.

Study groups in NCT05628259
Study groupRoleWhat they receive
Intervention GroupExperimentalA motivational interview (MI) program based on the telenursing approach was applied to the individuals in the experimental group. In this study, the MI procedure includes eight sessions in total, with four sessions of motivational interviews by phone in the first month of the intervention and four sessions of motivational interviews by phone in the next two months for each individual. Pre-tests were collected in the first month. Afterwards, MI intervention was applied for three months. This intervention was applied to the experimental group in addition to the routine care provided by the hospital. MI application took an average of 45-60 minutes via phone call.
Receives: Behavioral: Tele-Nursing based Motivational Interviewing
Control GroupNo interventionThe control group received routine nursing care in the diabetes policlinic.

What is being measured

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

  1. Diabetes Self-Efficacy Scale

    The change in diabetes self efficacy of individuals with Type 2 diabetes at 3rd month and 6 rd month with the Diabetes Self-Efficacy Scale.

    Measured: Change from Baseline diabetes self-efficacy at 6 months

  2. Diabetes Self-Management Scale

    This scale was used to measure the behavioral component of individuals in the IMB model. The validity and reliability study of the Turkish Diabetes Self-Management Perception Scale was conducted by Eroğlu and Sabuncu (2018). The scale consists of 16 items and 4 sub-dimensions and is a 4-point Likert type. Glucose Management sub-dimension: Items 4, 6, 10, 12 (items 4 and 12 are about drug use, items 1, 6 and 10 are about blood glucose monitoring). Diet Control sub-dimension: Items 2, 5, 9, 13. Physical Activity sub-dimension: Items 8, 11, 15. Use of Health Services sub-dimension: It consists of 3, 7, 14, and 16 items. The DMS scale consists of 16 items, 7 of which are straight and 9 of which are reversed. The scores of the items numbered "5, 7, 10, 11, 12, 13, 14, 15 and 16" in the scale are calculated by reversing them. Diabetes self-management increases as the score gets closer to 10.

    Measured: Change from Baseline diabetes self-management at 6 months

Secondary outcomes (8)

  1. HbA1c%

    Hemoglobin A1C

    Measured: Change from Baseline HbA1c% at 6 months

  2. BMI

    Body Mass Index

    Measured: Change from Baseline Body Mass Index at 6 months

  3. FBG

    Fasting blood glucose

    Measured: Change from Baseline Fasting glucose at 6 months

  4. LDL

    Low-density lipoprotein

    Measured: Change from Baseline LDL at 6 months

  5. HDL

    High-density lipoprotein

    Measured: Change from Baseline HDL at 6 months

  6. waist circumference

    waist circumference

    Measured: Change from Baseline waist circumference at 6 months

  7. Total cholesterol

    Total cholesterol

    Measured: Change from Baseline total cholesterol at 6 months

  8. Triglyceride

    triglyceride

    Measured: Change from Baseline total triglyceride at 6 months

Timeline

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

  1. First posted28 Nov 2022
  2. Study start1 Feb 2023
  3. Primary completion2 May 2023
  4. Study completion2 Oct 2023

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
Model description
This study is a parallel group randomized controlled study.
Masking
Single blind
Who is masked
Participant
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05628259
Sponsor's protocol ID
EKILINCISLEYEN
Status last verified
Mar 2024
First submitted
17 Nov 2022
Last updated
13 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Isleyen EK, Ozdemir IN, Yoldemir SA. The effect of tele-nursing based motivational interviewing on self-efficacy, self-management and metabolic control parameters in individuals with type 2 diabetes: randomized controlled study. Ir J Med Sci. 2025 Apr;194(2):563-573. doi: 10.1007/s11845-025-03916-5. Epub 2025 Feb 21.

    PubMed 39982630

Questions about this trial

What is this clinical trial studying?

A study testing Tele-Nursing based Motivational Interviewing in people with Type2 Diabetes and Self Efficacy, run by Pamukkale University at 3 sites 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 1 inclusion and 1 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 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Diabetes Self-Efficacy Scale (time frame: Change from Baseline diabetes self-efficacy at 6 months). 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 NCT05628259, which also lists 1 linked publication.

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 13 Mar 2024.

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