Diabetes Mellitus, Type 2NCT04260100
Diabetic Care Self-Management Mobile Health Application Among Diabetes Mellitus Clients in Malaysia
A study testing Diabetes Care Self-Management Mobile Health Application in people with Diabetes Mellitus, Type 2, run by Mohd Khairul Zul Hasymi Firdaus at 1 site in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Diabetes Care Self-Management Mobile Health Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteMalaysia
- Study dates
- 17 Feb 2020to 15 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Klinik Kesihatan UTC Kangar
Kangar, Perlis Indera Kayangan, 01000
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Diabetes Care Self-Management Mobile Health Application
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Care Self-Management Mobile Health ApplicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Behavioral: Diabetes Care Self-Management Mobile Health Application |
| Control Group | No intervention | Routine care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Care Behaviour
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.
Measured: 5 weeks; Baseline on Week 1 and follow up on Week 5
Dietary Behaviour
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.
Measured: 5 weeks; Baseline in Week 1 and follow up in Week 5
Secondary outcomes (2)
Foot Conditions
The foot conditions will be assessed twice (Week 1 and Week 5) by using foot condition assessment form.
Measured: 5 weeks; baseline in Week 1 and post intervention in Week 5
Fasting Blood Glucose
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.
Measured: 5 weeks; baseline in Week 1 and post intervention in Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start17 Feb 2020
- Primary completion3 Mar 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohd Khairul Zul Hasymi Firdaus
- Sponsor type
- University, hospital or other
- Collaborators
- Prince of Songkla University
- Responsible party
- Sponsor-investigator, Mohd Khairul Zul Hasymi Firdaus, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260100
- Sponsor's protocol ID
- Diabetic Care Mobile App
- Status last verified
- Mar 2021
- First submitted
- 5 Feb 2020
- Last updated
- 11 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Firdaus MKZH, Jittanoon P, Boonyasopun U, Che Hasan MK. The effect of mHealth program on behavior modification and health outcomes among patients with diabetes: A randomized controlled trial study. Belitung Nurs J. 2023 Oct 26;9(5):437-447. doi: 10.33546/bnj.2664. eCollection 2023.
PubMed 37901368
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04260100
- Acronym / sponsor ID
- Diabetic Care Mobile App
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Mohd Khairul Zul Hasymi FirdausUniversity, hospital or other
- Collaborators
- Prince of Songkla University
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 7 Feb 2020 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Diabetes Care Self-Management Mobile Health Application |
| Control Group | No intervention | –Routine care group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Diabetes Care Self-Management Mobile Health ApplicationIn 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. | Behavioural | Intervention Group |
Primary outcome
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.
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.
2 secondary outcomes
Foot Conditions
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Derived from this study: PubMed 37901368Firdaus MKZH, Jittanoon P, Boonyasopun U, Che Hasan MK. The effect of mHealth program on behavior modification and health outcomes among patients with diabetes: A randomized controlled trial study. Belitung Nurs J. 2023 Oct 26;9(5):437-447. doi: 10.33546/bnj.2664. eCollection 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Care Self-Management Mobile Health Application in people with Diabetes Mellitus, Type 2, run by Mohd Khairul Zul Hasymi Firdaus at 1 site in Malaysia.
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 9 inclusion and 3 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: finished, as of the sponsor's last update on 11 Mar 2021. 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 Malaysia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot Care Behaviour (time frame: 5 weeks; Baseline on Week 1 and follow up on Week 5). 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?
On the ClinicalTrials.gov record for NCT04260100, which also lists 1 linked publication.
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 11 Mar 2021.