Tittle: Effect of Video-Based Health Education Intervention on Insulin Therapy Among Adults With Diabetes Mellitus in Dhulikhel Hospital

NCT06435598 | Recruiting DMC

• 1 other identifier: 737/2023
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

Insulin is an essential therapy for treating diabetes, but many patients lack standard insulin injection skills. Learning the method of proper insulin injection technique is crucial for diabetes patients as it promotes treatment compliance, ensures safety, improves treatment efficacy, and contributes to better overall health outcomes. Adequate training and understanding of the proper technique enhance patient self-efficacy and empower them to take an active role in managing their diabetes mellitus. It empowers patients to effectively manage their diabetes and maintain optimal blood glucose control, ultimately leading to a better quality of life. This research aims to investigate the effectiveness of video-based health education in supporting insulin therapy in diabetes mellitus patients visiting Dhulikhel Hospital. With the increasing patients with insulin therapy and the need for effective patient education, it is essential to evaluate the impact of video-based educational interventions specifically tailored for patients undergoing insulin therapy. A randomized control trial method will be used for the study. Participants will be randomly assigned to either an experimental group receiving face to face educational session with video-based education or a control group receiving standard face-to-face educational session. Data will be collected through pre and post intervention assessments. The study's outcomes will help optimize patient care, increase accessibility to healthcare services and potentially reshape the way insulin therapy is delivered to Diabetes Mellitus patients.

Conditions

Knowledge on Insulin Therapy; Practice on Insulin Administration

Keywords

Diabetes mellitus; Educational Video on insulin therapy; Insulin Therapy for diabetes mellitus; Knowledge on insulin therapy; Practice on insulin administration; Usual Care on insulin administration

Outcome Measures

Primary Outcomes (2)

• Knowledge on insulin therapy

  Knowledge on insulin therapy will cover structured questionnaire

  4 months

• Practice of insulin administration technique

  Practice of insulin administration will be assessed by checklist

  4 months

Study Arms (2)

Intervention Group (Educational video and usual care)

EXPERIMENTAL

Investigator will allocate sixty- three of the participants to the video-based health education and usual care

Other: video-based health education

Control Group (Usual Care)

NO INTERVENTION

Investigator will allocate sixty-three of the participants to usual care only

Interventions

video-based health education OTHER

The video- based health education program guided by the Health Belief Model will be designed to provide tailored information on insulin therapy in diabetes. Health Belief Model(HBM) emphasizes changes in people's behavior are acquired through awareness of risk factors and perceived health benefits. The video will provide general information on insulin, types of insulin, its administration technique and storage.

Also known as: Usual Care

Intervention Group (Educational video and usual care)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult more than or equal to 18 years.
• Adult diagnosed with diabetes mellitus
• Adult under insulin therapy
• Adult owns smartphone with social media account

You may not qualify if:

• Patient with learning difficulties (dementia), hearing or visual impairment and hand tremors

Sponsors & Collaborators

• Kathmandu University School of Medical Sciences: lead

Study Sites (1)

Dhulikhel Hospital

Dhulikhel, Bagmati, 45210, Nepal

RECRUITING

Related Links

• Cui M, Wu X, Mao J, Wang X, Nie M (2016) T2DM Self-Management via Smartphone Applications: A Systematic Review and Meta-Analysis. PLOS ONE 11(11): e0166718
• 12\. Frid AH, Kreugel G, Grassi G, Halimi S, Hicks D, Hirsch LJ, et al. New Insulin Delivery Recommendations. Mayo Clin Proc \[Internet\]. 2016;91(9):1231-55

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Subina Manandhar, M.Sc.

  Kathmandu University School of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Kunta D Pun, PhD

  Kathmandu University School of Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Subina Manandhar, M.Sc

CONTACT

+977-9841726577; subina.manandhar@kusms.edu.np

Bhawana Shrestha, M.Sc.

CONTACT

+977-9802337704; bhawanakoju@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Nursing Department

Model Details: This is an open-label two-arm randomized trial. Investigator will allocate half of the participants to the video-based health education and usual care, while the other half of the participants will receive usual care only. (Fig 1) Randomization: Block randomization will be done to allocate adults to intervention or usual care group.

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 30, 2024
• Study Start: June 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: May 30, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)