Type II DiabetesmHealthNCT06387433
Effectiveness of an mHealth Mobile App
A study testing mobile app use in people with Type II Diabetes, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
Type II diabetes is a serious challenge for Pakistan. Not using medications properly increases healthcare costs and diabetes-related deaths. A mobile app in local language can improve medication adherence and self-management among diabetics. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type II Diabetes
- What is being tested?
- mobile app use
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2024to Aug 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults
- HbA1c more than or equal to 8.0 on most recent lab report within last 3 months
- able to comprehend Urdu language
Who cannot join
- type I diabetics,
- patients on continuous glucose monitoring,
- patients with severe mental or physical impairment,
- pregnant
- do not have access to smart phone
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
National Institute of Diabetes and Endocrinology
Karachi, Sindh
About this study
Official title: Assessing the Effectiveness of an mHealth Intervention Versus the Usual Standard of Care for Improving Medication Adherence and Self-management Among Type II Diabetics in Pakistan: A Randomized Controlled Trial
Type II diabetes is a serious challenge for Pakistan. Not using medications properly increases healthcare costs and diabetes-related deaths. A mobile app in local language can improve medication adherence and self-management among diabetics. Therefore, in this 18 months long study researchers will develop a diabetes-related mobile application in Urdu, and will conduct a trial to assess whether it improves medication compliance and self-management, and how much economical this app would be compared to the usual standard of care for type II diabetics in Pakistan. This trial will be conducted at the National Institute of Diabetes and Endocrinology Karachi. The study participants will be divided in two groups. Only one group will use this application. Researchers will measure medication compliance and self-management through diabetes-specific blood test and self-reporting questionnaires between two groups. Researchers will also determine how much economic costs would be saved by using this app to improve medication compliance
Read the detailed description
Type II diabetes continues to be a challenge for the resource-constrained healthcare system in Pakistan. Non-adherence to medications increases healthcare costs and disease-related mortality. Mobile health (mHealth), especially in local language, can improve medication adherence and self-management among diabetics. However, there are currently no validated diabetes-related apps available in Urdu for Pakistani population The objective of this study is to develop an android-compatible mobile application in Urdu, to assess its effectiveness in improving medication adherence and self-management, and to conduct an economic evaluation of this app against the usual standard of care for type II diabetics in Pakistan. This 18 months long randomized controlled trial will be conducted at the National Institute of Diabetes and Endocrinology Karachi. This bi-phasic study will involve the development and pilot testing of an android-compatible app, followed by an RCT to assess the effectiveness of this mobile app in improving medication adherence and self-management among type II diabetics in Pakistan. Medication adherence will be measured by the HbA1c levels and self-reported Morisky Medication Adherence Scale (Urdu version), while self- management will be assessed by Diabetes Self-Management Questionnaire (Urdu version). All outcomes will be assessed at 3 and 6 months. Intervention usability will be evaluated by the Mobile App Rating Scale (MARS) and economic effectiveness will be evaluated by EQ-5D-3L (Urdu version) to measure Quality Adjusted Life Years.
The expected outcome is the production of scientific evidence for the effectiveness and economic viability of a locally-validated mobile application for diabetes care and management in Pakistan
- Conditions
- Type II Diabetes
- Being tested
- mobile app use
- Keywords
- diabetes mellitus, mobile applications, Pakistan
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile app useBehavioural
The experimental group will use the mobile application while controlled group will not use mobile application. Investigators will assess the effectiveness of mobile application in ensuring medication adherence and self-management among diabetics in Pakistan
| Study group | Role | What they receive |
|---|---|---|
| mobile app users | Experimental | Not described Receives: Behavioral: mobile app use |
| mobile app non-users | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
adherence to medication
measured by Morisky Medication Adherence Scale .For Morisky Medication Adherence Scale, a score of less than 6 will be considered low adherence and higher scores will indicate better adherence
Measured: baseline, 3 and 6 months
self-management among diabetics
measured by Diabetes self-management questionnaire. This questionnaire has a scale from 0 to 10, with the score of 10 indicating the most effective self-care behaviour.
Measured: baseline, 3 and 6 months
effective management of diabetes
Adherence to treatment will also be assessed by the HbA1c levelsHbA1c levels of 8% or more will be considered diabetic, with higher score indicating poor control of diabetes
Measured: baseline, 3 and 6 months
Secondary outcomes (2)
Intervention usability
measured through Mobile Application Rating Scale. In this scale all points are rated on 5 point scale from 1 indicating 'inadequate' and 5 indicating 'excellent'
Measured: measured at 6 months following intervention
economic effectiveness of the app
measured through EQ-5D-3L. calculated by subtracting the values of the descriptive EQ-5D system from the numerical value 1. This corresponds to the best possible health status, while an index value of <0 represents the worst possible health status.
Measured: measured at 6 months following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start20 Mar 2024
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II DiabetesStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Maria Atif, Dow University of Health Sciences
- Investigators
- Maria Atif, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387433
- Sponsor's protocol ID
- mHealth
- Other IDs
- SG-222/R3-05/RDC/DUHS/1478
- Acronym
- mHealth
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of an mHealth Intervention Versus the Usual Standard of Care for Improving Medication Adherence and Self-management Among Type II Diabetics in Pakistan: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06387433
- Acronym / sponsor ID
- mHealth / mHealth
- Conditions
- Type II Diabetes
- Keywords
- diabetes mellitus, mobile applications, Pakistan
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 29 Apr 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.
Type II diabetes is a serious challenge for Pakistan. Not using medications properly increases healthcare costs and diabetes-related deaths. A mobile app in local language can improve medication adherence and self-management among diabetics. Therefore, in this 18 months long study researchers will develop a diabetes-related mobile application in Urdu, and will conduct a trial to assess whether it improves medication compliance and self-management, and how much economical this app would be compared to the usual standard of care for type II diabetics in Pakistan. This trial will be conducted at the National Institute of Diabetes and Endocrinology Karachi. The study participants will be divided in two groups. Only one group will use this application. Researchers will measure medication compliance and self-management through diabetes-specific blood test and self-reporting questionnaires between two groups. Researchers will also determine how much economic costs would be saved by using this app to improve medication compliance
Detailed description
Type II diabetes continues to be a challenge for the resource-constrained healthcare system in Pakistan. Non-adherence to medications increases healthcare costs and disease-related mortality. Mobile health (mHealth), especially in local language, can improve medication adherence and self-management among diabetics. However, there are currently no validated diabetes-related apps available in Urdu for Pakistani population The objective of this study is to develop an android-compatible mobile application in Urdu, to assess its effectiveness in improving medication adherence and self-management, and to conduct an economic evaluation of this app against the usual standard of care for type II diabetics in Pakistan. This 18 months long randomized controlled trial will be conducted at the National Institute of Diabetes and Endocrinology Karachi. This bi-phasic study will involve the development and pilot testing of an android-compatible app, followed by an RCT to assess the effectiveness of this mobile app in improving medication adherence and self-management among type II diabetics in Pakistan. Medication adherence will be measured by the HbA1c levels and self-reported Morisky Medication Adherence Scale (Urdu version), while self- management will be assessed by Diabetes Self-Management Questionnaire (Urdu version). All outcomes will be assessed at 3 and 6 months. Intervention usability will be evaluated by the Mobile App Rating Scale (MARS) and economic effectiveness will be evaluated by EQ-5D-3L (Urdu version) to measure Quality Adjusted Life Years.
The expected outcome is the production of scientific evidence for the effectiveness and economic viability of a locally-validated mobile application for diabetes care and management in Pakistan
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mobile app users | Experimental | Behavioral: mobile app use |
| mobile app non-users | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults
- HbA1c more than or equal to 8.0 on most recent lab report within last 3 months
- able to comprehend Urdu language
Key exclusion criteria (5 listed)
- type I diabetics,
- patients on continuous glucose monitoring,
- patients with severe mental or physical impairment,
- pregnant
- do not have access to smart phone
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 |
|---|---|---|
| mobile app useThe experimental group will use the mobile application while controlled group will not use mobile application. Investigators will assess the effectiveness of mobile application in ensuring medication adherence and self-management among diabetics in Pakistan | Behavioural | mobile app users |
Primary outcome
adherence to medication
Time frame: baseline, 3 and 6 months
measured by Morisky Medication Adherence Scale .For Morisky Medication Adherence Scale, a score of less than 6 will be considered low adherence and higher scores will indicate better adherence
self-management among diabetics
Time frame: baseline, 3 and 6 months
measured by Diabetes self-management questionnaire. This questionnaire has a scale from 0 to 10, with the score of 10 indicating the most effective self-care behaviour.
effective management of diabetes
Time frame: baseline, 3 and 6 months
Adherence to treatment will also be assessed by the HbA1c levelsHbA1c levels of 8% or more will be considered diabetic, with higher score indicating poor control of diabetes
2 secondary outcomes
Intervention usability
Time frame: measured at 6 months following intervention
economic effectiveness of the app
Time frame: measured at 6 months following intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- 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. This study is not recruiting at the moment.
Maria Atif principal investigator
Dow University of Health 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 mobile app use in people with Type II Diabetes, run by Dow University of Health Sciences at 1 site in Pakistan.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 Apr 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 Pakistan. 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?
Results are not available in the source record.
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?
adherence to medication (time frame: baseline, 3 and 6 months). The study lists 3 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 30 Apr 2024.