Knowledge on Insulin TherapyNCT06435598
Tittle: Effect of Video-Based Health Education Intervention on Insulin Therapy Among Adults With Diabetes Mellitus in Dhulikhel Hospital
A study testing video-based health education in people with Knowledge on Insulin Therapy and Practice on Insulin Administration, run by Kathmandu University School of Medical Sciences at 1 site in Nepal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Knowledge on Insulin Therapy, Practice on Insulin Administration
- What is being tested?
- video-based health education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jun 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult more than or equal to 18 years.
- Adult diagnosed with diabetes mellitus
- Adult under insulin therapy
- Adult owns smartphone with social media account
Who cannot join
- Patient with learning difficulties (dementia), hearing or visual impairment and hand tremors
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nepal1 site, 1 recruiting
- Recruiting
Dhulikhel Hospital
Dhulikhel, Bagmati, 45210
Subina Manandhar, M.Sc., 9841726577 ext. +977, subina.manandhar@kusms.edu.np
Bhawana Shrestha, M.Sc., 9802337704 ext. +977, bhawanakoju@gmail.com
About this study
Official title: Effect of Video-Based Health Education Intervention on Insulin Therapy Among Adults With Diabetes Mellitus in Dhulikhel Hospital: A Randomized Controlled Trial 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.
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.
Read the detailed description
Background:
The prevalence of diabetes is high, and is expected to increase in developing countries or regions such as China, India, Brazil and Southeast Asia. Diabetes Mellitus is a chronic condition that requires lifelong management insulin therapy being a crucial component for many patients. Proper understanding and adherence to insulin are essential for achieving optimal health outcomes. Patient education plays a vital role in enhancing knowledge, self-management skills, and treatment adherence. Video- based health education offers several advantages including accessibility, flexibility and the ability to provide visual demonstrations. It can empower patients to actively participate in their self-care and improve their overall well-being.
Proper injection technique ensures the safe and effective delivery of insulin into the body. This helps minimize the risk of complications such as infections, bruising, discomfort, pain and incorrect dosage administration. Proper injection depth, angle and site rotation contribute to consistent absorption of insulin, leading better blood glucose control. This is possible when patients are confident in their ability to administer insulin correctly with the right training and education.
Overall, this study holds significant importance as it addresses the gap in knowledge regarding the effectiveness of video-based health education in supporting insulin therapy for Diabetes Mellitus patients. Its findings will have implication for optimizing patient education strategies, enhancing treatment adherence and ultimately improving the quality of life for individuals living with Diabetes Mellitus.
Rational/justification:
By conducting this randomized controlled trial, Investigator aim to contribute to the patient education in diabetes management. It will help to optimize patient education methods, enhance treatment adherence and ultimately lead to better health outcomes for Diabetes mellitus patients on insulin therapy.
General Objective:
To explore whether the use of video-based health education program results in better knowledge, practice of insulin therapy technique when compared to usual care among adults with diabetes mellitus in Dhulikhel Hospital.
Specific Objective:
- To determine video-based health education program compared with usual care improves the practice score of insulin therapy technique among adults with diabetes mellitus in Dhulikhel Hospital.
- To find out video-based health education program compared with usual care increases the knowledge score of insulin therapy technique among adults with diabetes mellitus in Dhulikhel Hospital.
- To find out the association of practice of insulin therapy technique before the intervention with selected socio demographic variable.
Research Hypothesis Video-based health education intervention improves knowledge and practice of insulin therapy technique among adults with diabetes mellitus attending Dhulikhel Hospital.
Study Variables:
Dependent Variables: Knowledge and Practice in Insulin Therapy Independent Variables: Socio Demography Data, Educational Video Intervention
Research Method:
Quantitative
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. A random sequence number will be generated in blocks of size of ten using STATA 14 by a statistician. The random numbers will be copied in an excel form and median will be calculated for each block. The numbers below the median will be assigned as 'usual care group' and the numbers above the median will be assigned as 'intervention group'. Diabetic nurses and other nursing staff at the medical OPD and ward in Dhulikhel hospital will identify adults with diabetes and will check their eligibility. Investigator will explain ethical considerations, the importance of maintaining confidentiality during the research process, the voluntary nature of the participation, and the option to quit the study at any time. Investigator will enroll adults providing consent. After taking written consent, investigator will interview adults for baseline characteristics and their knowledge on insulin therapy. The interview will take 30-35 minutes.
Allocation concealment: A computer-based program will randomly allocate participants to either video-based education plus usual care or in a group with usual care only. Block randomization will be done to allocate adults to intervention or usual care group. A random sequence number will be generated in blocks of size of ten using STATA 14 by a statistician. The random numbers will be copied in an excel form and median will be calculated for each block. The numbers below the median will be assigned as 'usual care group' and the numbers above the median will be assigned as 'intervention group'. For randomization, the participants who have agreed to participate will be randomized into either the intervention or control group, with a 1:1 ratio based on allocation sequence. The allocation sequence will be concealed from the research nurse and participants using sequentially numbered opaque sealed envelopes (SNOSE) method. The principal investigator will provide the sealed envelopes to the research nurse who will then assign participants' to the intervention. The participants, the service provider, and the research nurse will be aware of the intervention.
Intervention: 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.
Usual Care: Both intervention and control group will receive the usual standard diabetic care from Dhulikhel hospital which includes diabetic counseling, health teachings, etc.
- Being tested
- video-based health education
- 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
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video-based health educationOther
Also called Usual Care
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: video-based health education |
| Control Group (Usual Care) | No intervention | Investigator will allocate sixty-three of the participants to usual care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge on insulin therapy
Knowledge on insulin therapy will cover structured questionnaire
Measured: 4 months
Practice of insulin administration technique
Practice of insulin administration will be assessed by checklist
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Jun 2024
- Primary completion28 Feb 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knowledge on Insulin TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kathmandu University School of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Subina Manandhar, Kathmandu University School of Medical Sciences
- Investigators
- Subina Manandhar, M.Sc., Principal investigator, Kathmandu University School of Medical SciencesKunta D Pun, PhD, Study director, Kathmandu University School of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435598
- Sponsor's protocol ID
- 737/2023
- Status last verified
- Nov 2024
- First submitted
- 15 May 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Video-Based Health Education Intervention on Insulin Therapy Among Adults With Diabetes Mellitus in Dhulikhel Hospital: A Randomized Controlled Trial 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.
- ClinicalTrials.gov ID
- NCT06435598
- Acronym / sponsor ID
- 737/2023
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Kathmandu University School of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
The prevalence of diabetes is high, and is expected to increase in developing countries or regions such as China, India, Brazil and Southeast Asia. Diabetes Mellitus is a chronic condition that requires lifelong management insulin therapy being a crucial component for many patients. Proper understanding and adherence to insulin are essential for achieving optimal health outcomes. Patient education plays a vital role in enhancing knowledge, self-management skills, and treatment adherence. Video- based health education offers several advantages including accessibility, flexibility and the ability to provide visual demonstrations. It can empower patients to actively participate in their self-care and improve their overall well-being.
Proper injection technique ensures the safe and effective delivery of insulin into the body. This helps minimize the risk of complications such as infections, bruising, discomfort, pain and incorrect dosage administration. Proper injection depth, angle and site rotation contribute to consistent absorption of insulin, leading better blood glucose control. This is possible when patients are confident in their ability to administer insulin correctly with the right training and education.
Overall, this study holds significant importance as it addresses the gap in knowledge regarding the effectiveness of video-based health education in supporting insulin therapy for Diabetes Mellitus patients. Its findings will have implication for optimizing patient education strategies, enhancing treatment adherence and ultimately improving the quality of life for individuals living with Diabetes Mellitus.
Rational/justification:
By conducting this randomized controlled trial, Investigator aim to contribute to the patient education in diabetes management. It will help to optimize patient education methods, enhance treatment adherence and ultimately lead to better health outcomes for Diabetes mellitus patients on insulin therapy.
General Objective:
To explore whether the use of video-based health education program results in better knowledge, practice of insulin therapy technique when compared to usual care among adults with diabetes mellitus in Dhulikhel Hospital.
Specific Objective:
- To determine video-based health education program compared with usual care improves the practice score of insulin therapy technique among adults with diabetes mellitus in Dhulikhel Hospital.
- To find out video-based health education program compared with usual care increases the knowledge score of insulin therapy technique among adults with diabetes mellitus in Dhulikhel Hospital.
- To find out the association of practice of insulin therapy technique before the intervention with selected socio demographic variable.
Research Hypothesis Video-based health education intervention improves knowledge and practice of insulin therapy technique among adults with diabetes mellitus attending Dhulikhel Hospital.
Study Variables:
Dependent Variables: Knowledge and Practice in Insulin Therapy Independent Variables: Socio Demography Data, Educational Video Intervention
Research Method:
Quantitative
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. A random sequence number will be generated in blocks of size of ten using STATA 14 by a statistician. The random numbers will be copied in an excel form and median will be calculated for each block. The numbers below the median will be assigned as 'usual care group' and the numbers above the median will be assigned as 'intervention group'. Diabetic nurses and other nursing staff at the medical OPD and ward in Dhulikhel hospital will identify adults with diabetes and will check their eligibility. Investigator will explain ethical considerations, the importance of maintaining confidentiality during the research process, the voluntary nature of the participation, and the option to quit the study at any time. Investigator will enroll adults providing consent. After taking written consent, investigator will interview adults for baseline characteristics and their knowledge on insulin therapy. The interview will take 30-35 minutes.
Allocation concealment: A computer-based program will randomly allocate participants to either video-based education plus usual care or in a group with usual care only. Block randomization will be done to allocate adults to intervention or usual care group. A random sequence number will be generated in blocks of size of ten using STATA 14 by a statistician. The random numbers will be copied in an excel form and median will be calculated for each block. The numbers below the median will be assigned as 'usual care group' and the numbers above the median will be assigned as 'intervention group'. For randomization, the participants who have agreed to participate will be randomized into either the intervention or control group, with a 1:1 ratio based on allocation sequence. The allocation sequence will be concealed from the research nurse and participants using sequentially numbered opaque sealed envelopes (SNOSE) method. The principal investigator will provide the sealed envelopes to the research nurse who will then assign participants' to the intervention. The participants, the service provider, and the research nurse will be aware of the intervention.
Intervention: 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.
Usual Care: Both intervention and control group will receive the usual standard diabetic care from Dhulikhel hospital which includes diabetic counseling, health teachings, etc.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Educational video and usual care) | Experimental | Other: video-based health educationInvestigator will allocate sixty- three of the participants to the video-based health education and usual care |
| Control Group (Usual Care) | No intervention | –Investigator will allocate sixty-three of the participants to usual care only |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult more than or equal to 18 years.
- Adult diagnosed with diabetes mellitus
- Adult under insulin therapy
- Adult owns smartphone with social media account
Key exclusion criteria (1 listed)
- Patient with learning difficulties (dementia), hearing or visual impairment and hand tremors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| video-based health educationAlso: Usual CareThe 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. | Other | Intervention Group (Educational video and usual care) |
Primary outcome
Knowledge on insulin therapy
Time frame: 4 months
Knowledge on insulin therapy will cover structured questionnaire
Practice of insulin administration technique
Time frame: 4 months
Practice of insulin administration will be assessed by checklist
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- 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): e0166718Link provided by the sponsor.
- 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):1231-55Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Subina Manandhar, M.Sc. principal investigator
Kathmandu University School of Medical Sciences
Kunta D Pun, PhD study director
Kathmandu University School of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video-based health education in people with Knowledge on Insulin Therapy and Practice on Insulin Administration, run by Kathmandu University School of Medical Sciences at 1 site in Nepal.
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 4 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: looking for participants now, as of the sponsor's last update on 25 Nov 2024. 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 Nepal. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Subina Manandhar, M.Sc (+977-9841726577, subina.manandhar@kusms.edu.np), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge on insulin therapy (time frame: 4 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?
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 25 Nov 2024.