The Effect of Motivational Interviewing With Video Call in Individuals With Type 2 Diabetes:RCT

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Motivational Interviewing with WhatsApp video call

About this trial

This is an interventional supportive care trial for Type2 Diabetes

Eligibility Criteria

30 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Those between the ages of 30-64 Receiving insulin therapy Diagnosed with type 2 diabetes at least six months ago BMI value of 25 and above HbA1c of 8 and above (poor control) At least primary school graduate and can speak Turkish No communication barrier (speech, vision or hearing problem) Having a smart phone and internet access Individuals who agree to participate in the research. Exclusion Criteria: Communication disability (speech, vision or hearing problem) Those with neuropathy at a level that prevents them from doing their daily physical activities Diagnosed with kidney failure (acute or chronic) Pregnant Those with a diagnosis of cancer

Sites / Locations

Eda Kılınç İşleyen
İrem Nur ÖZDEMİR
Şengül AYDIN YOLDEMİR

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

The control group received routine nursing care in the internal diseases policlinic.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

HbA1c%

Body Mass Index

Fasting glucose

Cholesterol

waist circumference

Blood pressure

Full Information

NCT ID

NCT05628259

First Posted

November 17, 2022

Last Updated

November 25, 2022

Sponsor

Pamukkale University

Collaborators

Bakırkoy Dr. Sadi Konuk Training and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05628259

Brief Title

The Effect of Motivational Interviewing With Video Call in Individuals With Type 2 Diabetes:RCT

Official Title

The Effect of Motivational Interviewing With Video Call on Diabetes Self-Efficacy, Diabetes Self-Management and Metabolic Control Parameters in Individuals With Type 2 Diabetes: A Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 2, 2023 (Anticipated)

Primary Completion Date

April 2, 2023 (Anticipated)

Study Completion Date

July 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Pamukkale University

Collaborators

Bakırkoy Dr. Sadi Konuk Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

Brief Summary

This study will be carried out to examine the effect of motivational interviewing applied by video call on diabetes self-efficacy, diabetes self-management and metabolic control parameters (HbA1c%, BMI, fasting glucose, cholesterol, blood pressure, waist circumference) in individuals with type 2 diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type2 Diabetes, Self Efficacy, Self Management, Video Call, HbA1c, BMI, Blood Pressure, Fasting Glucose, Cholesterol Deposition

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This study is a parallel group randomized controlled study.

Masking

Participant

Masking Description

Single blinding was provided that included inclusion criteria and agreement to participate in the study.

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

The control group received routine nursing care in the internal diseases policlinic.

Intervention Type

Behavioral

Intervention Name(s)

Motivational Interviewing with WhatsApp video call

Intervention Description

The individuals in the intervention group will be given a motivational interview with a WhatsApp video call for 3 months. Motivational interview will be applied every two weeks, 6 times in total.

Primary Outcome Measure Information:

Title

Diabetes Self-Efficacy Scale

Description

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.

Time Frame

Change from Baseline diabetes self-efficacy at 6 months

Title

Diabetes Self-Management Scale

Description

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.

Time Frame

Change from Baseline diabetes self-management at 6 months

Secondary Outcome Measure Information:

Title

HbA1c%

Time Frame

Change from Baseline HbA1c% at 6 months

Title

Body Mass Index

Time Frame

Change from Baseline Body Mass Index at 6 months

Title

Fasting glucose

Time Frame

Change from Baseline Fasting glucose at 6 months

Title

Cholesterol

Time Frame

Change from Baseline Cholesterol at 6 months

Title

waist circumference

Time Frame

Change from Baseline waist circumference at 6 months

Title

Blood pressure

Time Frame

Change from Baseline blood pressure % at 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Those between the ages of 30-64 Receiving insulin therapy Diagnosed with type 2 diabetes at least six months ago BMI value of 25 and above HbA1c of 8 and above (poor control) At least primary school graduate and can speak Turkish No communication barrier (speech, vision or hearing problem) Having a smart phone and internet access Individuals who agree to participate in the research. Exclusion Criteria: Communication disability (speech, vision or hearing problem) Those with neuropathy at a level that prevents them from doing their daily physical activities Diagnosed with kidney failure (acute or chronic) Pregnant Those with a diagnosis of cancer

Facility Information:

Facility Name

Eda Kılınç İşleyen

City

Pamukkale

State/Province

Denizli

ZIP/Postal Code

(545)-561 96 83

Country

Turkey

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eda Kılınç İşleyen, PhD, RN.

Phone

+905455619683

Email

kilinc_edaa@hotmail.com

Facility Name

İrem Nur ÖZDEMİR

City

Istanbul

Country

Turkey

Facility Contact:

First Name & Middle Initial & Last Name & Degree

İrem Nur ÖZDEMİR, PhD

Phone

+905076472107

Email

iremozdemir92@gmail.com

Facility Name

Şengül AYDIN YOLDEMİR

City

Istanbul

Country

Turkey

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Şengül AYDIN YOLDEMİR, PhD. MD.

Phone

+90(530)9383833

Email

sengulaydinn@gmail.com

Type2 Diabetes, Self Efficacy, Self Management

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial