NCT06325917

Brief Summary

Introduction: Diabetes mellitus (DM) is one of the chronic diseases that can have an impact on increasing morbidity, disability, and death. Social media has become a valuable resource for people with diabetes in improving self-management skills Applying diabetes self-management education with ongoing support using social media produces behavioral changes, empowerment, and cost-effectiveness. purpose: the purpose of this study is to examine the effect of self-management education with ongoing support using social media (WhatsApp) on glycemic control among patients with uncontrolled diabetes. Method: 140 patients with diabetes type 2 attending outpatients' diabetes clinic setting in Aqaba will participate in a two-arm randomized controlled trial study. Self-management education will be applied for all participants, ongoing support using social media (what's app) will be applied to the intervention group, and only usual diabetes care by a diabetes specialist nurse will be applied to the control group.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2023

Completed
10 months until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

1.7 years

First QC Date

June 6, 2023

Last Update Submit

March 16, 2024

Conditions

Keywords

DiabetesGlycemic controlself-management education

Outcome Measures

Primary Outcomes (1)

  • glycemic control

    This is the primary outcome of the study that will be assessed by the Glycated hemoglobin (A1C)

    baseline and three Monthes post intervention

Secondary Outcomes (1)

  • diabetes self management behaviors

    Three moths after the intervention

Study Arms (2)

whatsApp ongoing support

EXPERIMENTAL

70 patients will receive the usual care by DSN in the diabetes clinic through monthly visits supported by ongoing follow-up via what's App for a 3month.

Behavioral: what's app ongoing support

usual care

PLACEBO COMPARATOR

monthly follow-up at the diabetes education clinic patients receiving individual care and education by diabetes nurse specialist

Behavioral: usual care

Interventions

daily educational messages and reminders sent through WhatsApp. The educational material related to diabetes self-management behaviors (AADE7 Self-Care Behaviors, diabetes and genetics, and endocrinology center, also the Ministry of Health in Jordan diabetes. individual bidirectional communication between the participants and the investigator, which will allow participants to seek advice and get free-of-charge feedback and consultation.

whatsApp ongoing support
usual careBEHAVIORAL

monthly visit and follow-up at the diabetes education clinic by a diabetes nurse specialist providing DSMES

usual care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • have a confirmed diagnosis of DM2 in their medical records at last one year.
  • age 18 years old or more
  • able to read and write Arabic
  • agree to participate in the study
  • have uncontrolled blood sugar with HbA1C 8% or more
  • able to use the WhatsApp application
  • Having the ability to autonomous behavior

You may not qualify if:

  • the presence of mental disorders
  • complications of acute diabetes or inability to take care of themselves
  • other serious diseases, such as severe cardiovascular and cerebrovascular diseases, severe kidney disease stage 3, cancer, and visual impairment due to complications of T2DM
  • gestational diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Jordan

Amman, 11942, Jordan

Location

Related Publications (9)

  • Gabarron E, Arsand E, Wynn R. Social Media Use in Interventions for Diabetes: Rapid Evidence-Based Review. J Med Internet Res. 2018 Aug 10;20(8):e10303. doi: 10.2196/10303.

    PMID: 30097421BACKGROUND
  • Zisman-Ilani Y, Obeidat R, Fang L, Hsieh S, Berger Z. Shared Decision Making and Patient-Centered Care in Israel, Jordan, and the United States: Exploratory and Comparative Survey Study of Physician Perceptions. JMIR Form Res. 2020 Aug 3;4(8):e18223. doi: 10.2196/18223.

    PMID: 32744509BACKGROUND
  • Ajlouni K, Batieha A, Jaddou H, Khader Y, Abdo N, El-Khateeb M, Hyassat D, Al-Louzi D. Time trends in diabetes mellitus in Jordan between 1994 and 2017. Diabet Med. 2019 Sep;36(9):1176-1182. doi: 10.1111/dme.13894. Epub 2019 Jan 25.

  • Omar MA, Hasan S, Palaian S, Mahameed S. The impact of a self-management educational program coordinated through WhatsApp on diabetes control. Pharm Pract (Granada). 2020 Apr-Jun;18(2):1841. doi: 10.18549/PharmPract.2020.2.1841. Epub 2020 May 3.

  • American Association of Diabetes Educators. An Effective Model of Diabetes Care and Education: Revising the AADE7 Self-Care Behaviors(R). Diabetes Educ. 2020 Apr;46(2):139-160. doi: 10.1177/0145721719894903. Epub 2020 Jan 12.

  • Azami G, Soh KL, Sazlina SG, Salmiah MS, Aazami S, Mozafari M, Taghinejad H. Effect of a Nurse-Led Diabetes Self-Management Education Program on Glycosylated Hemoglobin among Adults with Type 2 Diabetes. J Diabetes Res. 2018 Jul 8;2018:4930157. doi: 10.1155/2018/4930157. eCollection 2018.

  • Pal K, Dack C, Ross J, Michie S, May C, Stevenson F, Farmer A, Yardley L, Barnard M, Murray E. Digital Health Interventions for Adults With Type 2 Diabetes: Qualitative Study of Patient Perspectives on Diabetes Self-Management Education and Support. J Med Internet Res. 2018 Jan 29;20(2):e40. doi: 10.2196/jmir.8439.

  • Ventola CL. Social media and health care professionals: benefits, risks, and best practices. P T. 2014 Jul;39(7):491-520.

  • Cashmore BA, Cooper TE, Evangelidis NM, Green SC, Lopez-Vargas P, Tunnicliffe DJ. Education programmes for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD007374. doi: 10.1002/14651858.CD007374.pub3.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: two arms parallel randomized controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 6, 2023

First Posted

March 22, 2024

Study Start

November 1, 2022

Primary Completion

July 1, 2024

Study Completion

July 30, 2024

Last Updated

March 22, 2024

Record last verified: 2024-03

Locations