- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04260100
Diabetic Care Self-Management Mobile Health Application Among Diabetes Mellitus Clients in Malaysia
March 9, 2021 updated by: Mohd Khairul Zul Hasymi Firdaus
The Effects of Diabetic Care Self-Management Mobile Health Application on Foot Care Behaviour, Dietary Behaviour, Foot Conditions and Fasting Blood Glucose Among Diabetes Mellitus Clients in Malaysia
The main purpose of this study is to explore the effect of Diabetic Care Self-Management Mobile Health Application in behavioral modification i.e foot care behaviour and dietary behaviour among diabetic clients in Malaysia.
Diabetic Care Self-Management Mobile Health Application is a mobile health (mHealth) application program aiming for primary care in health prevention and promotion activity.
The program is developed by the researcher through the literature review conducted.
The program is evaluated through a randomized controlled trial study design.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Perlis Indera Kayangan
-
Kangar, Perlis Indera Kayangan, Malaysia, 01000
- Klinik Kesihatan UTC Kangar
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Past readings of A1c more than 6.5% (Ministry of Health Malaysia, 2015).
- Has at least Stage 1 or above for the risk of foot ulcer development. The risk will be identified through diabetic foot screening. The screening will be carried out by using Inlow's 60 Second Diabetic Foot Screen.
- Age of 18 to 65 years old. Since the study is using mobile health applications, technology literate is an important factor to see the effect of mHealth on behaviour modification process. If the patient is more than 65 years old, the patient might have some difficulties in using mobile health intervention. Meanwhile, for the patient less than 18 years old, guardian permission is required prior to study enrolment.
- Have no history of diabetic foot ulcers.
- Able to independently perform self-care.
- Able to use a mobile application program.
- Own an android phone.
- No vision or hearing problem may interfere with the process of data collection and intervention carried out.
- Able to communicate in either English or Bahasa Malaysia (a native and official language of the country)
Exclusion Criteria:
- The patient that did not come for the follow-up care at Week 5. For instance, the patient may have other matters on the day of follow-up up which required their urgent attention and not able to come for the follow-up, or is stay outside of the area during the day of follow up.
- Have difficulty in performing foot care during in the middle of the intervention period. For example, the client may get sick due to hypoglycemic or hyperglycemic attack which stopped them from being able to perform the foot care behaviour.
- The patient is diagnosed with any cognitive and perceptual decline function
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
|
In day 1, the participant will receive a Foot Care Kit consist of a mirror, a tube of lotion, a small towel, and a nail clipper.
The participant will enrol in 3-hour workshop for general management of diabetes mellitus, diabetic foot care and dietary management.
The participant will be invited to install Diabetes Care Self-Management Mobile Health Application.
The mobile application is meant for sources of referral for diabetic foot care and dietary care, and for record purpose (diary) of any foot care activities carried out that participant needs to enter in the application during his/her home.
The participant will be trained for the use of Diabetes Care Mobile Health Application.
In addition, the participant will be invited to join a WhatsApp group for the medium of communication.
The program will be lasting for 5 weeks.
|
No Intervention: Control Group
Routine care group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Foot Care Behaviour
Time Frame: 5 weeks; Baseline on Week 1 and follow up on Week 5
|
The changes of foot care behaviour will be measured twice (Week 1 and Week 5) by using Diabetic Foot Selfcare Behaviour Scale (DFSBS).
The questionnaire consist of two parts namely Part 1 and Part 2 with two set of different responses.
In Part 1, there are four different questions measuring the self-care activity.
The response for this Part 1 consists of days performed from 0 - 7 days.
The response will be categorized based on Likert Scale according to the following categories; 0 days for score of 1, 1-2 days for score of 2, 3-4 days for score of 3, 5-6 days for score of 4 and 7 days for score of 5.
In Part 2, the question responses are categorized as never (1), seldom (2), sometimes (3), frequently (4) and always (5).
The total score accumulated will be in range of 7 - 35.
The interpretation of the score will be the higher the score, the better the foot care behaviour.
|
5 weeks; Baseline on Week 1 and follow up on Week 5
|
Dietary Behaviour
Time Frame: 5 weeks; Baseline in Week 1 and follow up in Week 5
|
The changes of dietary behaviour will be measured twice (Week 1 and Week 5) by using translated Dietary Behavior Questionnaire (DBQ).
The questionnaire consists of 30 items with four domains.
The domains are selecting a healthy diet with 13 items; arranging a meal plan, 7 items; recognizing the amount of calorie needs, 5 items and managing dietary behaviour challenges, 5 items.
5 points of Likert scale is use from 0 to 4 with 0 for never, 1 for seldom, 2 for occasionally, 3 for often and 4 for repeatedly.
The total score of DBQ is ranging from 0 to 120 with score of 0 to 40 categorized as poor behaviour, 41 to 80 categorized as medium and 81 to 120 categorized as better dietary behaviour.
|
5 weeks; Baseline in Week 1 and follow up in Week 5
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Foot Conditions
Time Frame: 5 weeks; baseline in Week 1 and post intervention in Week 5
|
The foot conditions will be assessed twice (Week 1 and Week 5) by using foot condition assessment form.
|
5 weeks; baseline in Week 1 and post intervention in Week 5
|
Fasting Blood Glucose
Time Frame: 5 weeks; baseline in Week 1 and post intervention in Week 5
|
The level of fasting blood glucose will be assessed twice (Week 1 and Week 5) by withdrawing participants blood for the test.The test will be sent to a certified laboratory for the analysis of FBG reading.
Prior to blood taking procedure, the participants will be asked to fast.
|
5 weeks; baseline in Week 1 and post intervention in Week 5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 17, 2020
Primary Completion (Actual)
March 3, 2020
Study Completion (Actual)
September 15, 2020
Study Registration Dates
First Submitted
February 5, 2020
First Submitted That Met QC Criteria
February 5, 2020
First Posted (Actual)
February 7, 2020
Study Record Updates
Last Update Posted (Actual)
March 11, 2021
Last Update Submitted That Met QC Criteria
March 9, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Diabetic Care Mobile App
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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