Noncommunicable DiseasesNCT05699369
Interventions to Improve Non-communicable Disease Management During the Pandemic
A study testing Digital health interventions in people with Noncommunicable Diseases and COVID-19, run by University of Toronto at 1 site in Pakistan.
Trial summary
This randomized controlled trial aims to implement and evaluate a comprehensive package of digital health interventions for integrated COVID-non-communicable diseases (NCDs) care to manage NCDs in primary care facilities in rural Pakistan. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Noncommunicable Diseases, COVID-19
- What is being tested?
- Digital health interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,965 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2023to 31 Aug 2024
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Reside in the catchment of selected rural health centers;
- Provide informed consent;
- Newly diagnosed of hypertension, i.e., having a baseline blood pressure reading (recorded from the second blood pressure reading using a validated electronic blood pressure machine) of more than 140/90 mmHg; or who is an existing hypertensive patient but with uncontrolled blood pressure with a baseline blood pressure over 140/90 mmHg;
- Have a smartphone or can access a smartphone from a relative.
Who cannot join
- Patients having an acute cardiovascular event in the last three months, terminal disease, or other conditions that the rural health center staff determine that will make participation impossible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cluster Randomised Controlled Trial to Evaluate the Effectiveness of Digital Health Interventions in Improving Non-communicable Disease Management During the Pandemic in Rural Pakistan
This randomized controlled trial aims to implement and evaluate a comprehensive package of digital health interventions for integrated COVID-non-communicable diseases (NCDs) care to manage NCDs in primary care facilities in rural Pakistan. The main questions it aims to answer are 1) whether such interventions are effective; 2) how they were implemented; and 3) whether such interventions are cost-effective.
30 rural health centers in Punjab Province, Pakistan will be randomized into two groups. The intervention group will provide a comprehensive package of digital health interventions to connect patients, patient champions, and public health providers to improve the management of NCDs during the pandemic, including 1) providing training to health providers regarding an integrated NCD-COVID guideline; 2) using a smartphone app to improve NCD case management and linking with patient champions; and 3) employing telementoring platform to improve quality of care. Usual care will be provided in the control group. Researchers will compare the two groups to see if the systolic blood pressure can be controlled better in the intervention group at 12 months.
- Conditions
- Noncommunicable Diseases, COVID-19
- Being tested
- Digital health interventions
- Keywords
- digital health interventions, non-communicable diseases, cluster randomised trial, implementation science, resilience, Pakistan
- Medical subject headings
- Noncommunicable Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital health interventionsOther
Described in arm descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | A comprehensive package of digital health interventions to connect patients, patient champions and public health providers to improve the management of non-communicable diseases (NCDs) during the pandemic will be implemented, including 1) providing training to health providers regarding an integrated NCD-COVID guideline; 2) using a smartphone app to improve NCD case management and linking with patient champions; and 3) employing telementoring platform to improve quality of care. Patient champions are experienced patients who can provide peer support. Receives: Other: Digital health interventions |
| Control arm | No intervention | Usual care, which is routine hypertension and diabetes diagnosis and treatment under the World Diabetes Foundation (WDF) project will be implemented. The WDF project provides initial Zoom-based training of NCD care to rural health center (RHC) staff, but no tele-mentorship is offered. Under the usual care, patients with hypertension or diabetes are required to visit RHCs every month to renew their medications and measure their blood pressure. No other interventional components will be implemented in the control arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure (mmHg) measured in the rural health center
Following the Trial Steering Committee's decision in October 2023, the intervention period was extended from 10 to 12 months; consequently, the timing of the outcome measure was rescheduled to Month 12.
Measured: At 12 months
Secondary outcomes (9)
Diastolic blood pressure (mmHg) measured in the rural health center
Following the Trial Steering Committee's decision in October 2023, the intervention period was extended from 10 to 12 months; consequently, the timing of the outcome measure was rescheduled to Month 12.
Measured: At 12 months
Percentage of patients with controlled blood pressure measured below 140/90 mmHg for patients with hypertension but without diabetes, and below 130/80 mmHg for patients with diabetes
Following the Trial Steering Committee's decision in October 2023, the intervention period was extended from 10 to 12 months; consequently, the timing of the outcome measure was rescheduled to Month 12.
Measured: At 12 months
Random blood glucose (mmol/L)
Following the Trial Steering Committee's decision in October 2023, the intervention period was extended from 10 to 12 months; consequently, the timing of the outcome measure was rescheduled to Month 12.
Measured: At 12 months
Body mass index (BMI)
Following the Trial Steering Committee's decision in October 2023, the intervention period was extended from 10 to 12 months; consequently, the timing of the outcome measure was rescheduled to Month 12.
Measured: At 12 months
Number of consultations with RHC doctors, including both in-person and virtual consultations
Following the Trial Steering Committee's decision in October 2023, the intervention period was extended from 10 to 12 months.
Measured: During the 12-month intervention period
Systolic and diastolic blood pressure
Measured: At 6 months
Proportion of patients who have had at least three doses of COVID vaccinations
Following the Trial Steering Committee's decision in October 2023, the intervention period was extended from 10 to 12 months; consequently, the timing of the outcome measure was rescheduled to Month 12.
Measured: At 12 months
Proportion of participants been admitted to district hospitals for any reasons
Following the Trial Steering Committee's decision in October 2023, the intervention period was extended from 10 to 12 months.
Measured: During the 12-month intervention period
All-cause mortality rate
Following the Trial Steering Committee's decision in October 2023, the intervention period was extended from 10 to 12 months.
Measured: During the 12-month intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Feb 2023
- Primary completion31 May 2024
- Study completion31 Aug 2024
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 Noncommunicable DiseasesStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,965 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Association for Social Development, Pakistan
- Responsible party
- Principal investigator, Xiaolin Wei, University of Toronto
- Investigators
- Xiaolin Wei, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699369
- Sponsor's protocol ID
- PRCT202112
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2023
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the ethical agreements, the data is only available for research purpose of the study team. Individual patient data cannot be posted and downloaded in a public data depository. Anonymous data can be shared upon request to the study contacts with joint ethics application to the University of Toronto.
Publications
Wei X, Khan N, Durrani H, Muzaffar N, Haldane V, Walley JD, Thorpe K, Ge E, Ge S, Dodd W, Wallace J, Aslanyan G, Laporte A, Khan MA. Protocol for a pragmatic cluster randomised controlled trial to evaluate the effectiveness of digital health interventions in improving non-communicable disease management during the pandemic in rural Pakistan. PLoS One. 2023 Oct 10;18(10):e0282543. doi: 10.1371/journal.pone.0282543. eCollection 2023.
PubMed 37816010
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomised Controlled Trial to Evaluate the Effectiveness of Digital Health Interventions in Improving Non-communicable Disease Management During the Pandemic in Rural Pakistan
- ClinicalTrials.gov ID
- NCT05699369
- Acronym / sponsor ID
- PRCT202112
- Conditions
- Noncommunicable Diseases, COVID-19
- Keywords
- digital health interventions, non-communicable diseases, cluster randomised trial, implementation science, resilience, Pakistan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,965 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Association for Social Development, Pakistan
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 26 Jan 2023 (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.
This randomized controlled trial aims to implement and evaluate a comprehensive package of digital health interventions for integrated COVID-non-communicable diseases (NCDs) care to manage NCDs in primary care facilities in rural Pakistan. The main questions it aims to answer are 1) whether such interventions are effective; 2) how they were implemented; and 3) whether such interventions are cost-effective.
30 rural health centers in Punjab Province, Pakistan will be randomized into two groups. The intervention group will provide a comprehensive package of digital health interventions to connect patients, patient champions, and public health providers to improve the management of NCDs during the pandemic, including 1) providing training to health providers regarding an integrated NCD-COVID guideline; 2) using a smartphone app to improve NCD case management and linking with patient champions; and 3) employing telementoring platform to improve quality of care. Usual care will be provided in the control group. Researchers will compare the two groups to see if the systolic blood pressure can be controlled better in the intervention group at 12 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Digital health interventionsA comprehensive package of digital health interventions to connect patients, patient champions and public health providers to improve the management of non-communicable diseases (NCDs) during the pandemic will be implemented, including 1) providing training to health providers regarding an integrated NCD-COVID guideline; 2) using a smartphone app to improve NCD case management and linking with patient champions; and 3) employing telementoring platform to improve quality of care. Patient champions are experienced patients who can provide peer support. |
| Control arm | No intervention | –Usual care, which is routine hypertension and diabetes diagnosis and treatment under the World Diabetes Foundation (WDF) project will be implemented. The WDF project provides initial Zoom-based training of NCD care to rural health center (RHC) staff, but no tele-mentorship is offered. Under the usual care, patients with hypertension or diabetes are required to visit RHCs every month to renew their medications and measure their blood pressure. No other interventional components will be implemented in the control arm. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Reside in the catchment of selected rural health centers;
- Provide informed consent;
- Newly diagnosed of hypertension, i.e., having a baseline blood pressure reading (recorded from the second blood pressure reading using a validated electronic blood pressure machine) of more than 140/90 mmHg; or who is an existing hypertensive patient but with uncontrolled blood pressure with a baseline blood pressure over 140/90 mmHg;
- Have a smartphone or can access a smartphone from a relative.
Key exclusion criteria (1 listed)
- Patients having an acute cardiovascular event in the last three months, terminal disease, or other conditions that the rural health center staff determine that will make participation impossible.
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 |
|---|---|---|
| Digital health interventionsDescribed in arm descriptions. | Other | Intervention arm |
Primary outcome
Systolic blood pressure (mmHg) measured in the rural health center
Time frame: At 12 months
Following the Trial Steering Committee's decision in October 2023, the intervention period was extended from 10 to 12 months; consequently, the timing of the outcome measure was rescheduled to Month 12.
9 secondary outcomes
Diastolic blood pressure (mmHg) measured in the rural health center
Time frame: At 12 months
Percentage of patients with controlled blood pressure measured below 140/90 mmHg for patients with hypertension but without diabetes, and below 130/80 mmHg for patients with diabetes
Time frame: At 12 months
Random blood glucose (mmol/L)
Time frame: At 12 months
Body mass index (BMI)
Time frame: At 12 months
Number of consultations with RHC doctors, including both in-person and virtual consultations
Time frame: During the 12-month intervention period
Systolic and diastolic blood pressure
Time frame: At 6 months
Proportion of patients who have had at least three doses of COVID vaccinations
Time frame: At 12 months
Proportion of participants been admitted to district hospitals for any reasons
Time frame: During the 12-month intervention period
All-cause mortality rate
Time frame: During the 12-month intervention period
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 29 Sep 2026.
- Derived from this study: PubMed 37816010Wei X, Khan N, Durrani H, Muzaffar N, Haldane V, Walley JD, Thorpe K, Ge E, Ge S, Dodd W, Wallace J, Aslanyan G, Laporte A, Khan MA. Protocol for a pragmatic cluster randomised controlled trial to evaluate the effectiveness of digital health interventions in improving non-communicable disease management during the pandemic in rural Pakistan. PLoS One. 2023 Oct 10;18(10):e0282543. doi: 10.1371/journal.pone.0282543. eCollection 2023.
- Individual participant dataSharing planned: Yes. According to the ethical agreements, the data is only available for research purpose of the study team. Individual patient data cannot be posted and downloaded in a public data depository. Anonymous data can be shared upon request to the study contacts with joint ethics application to the University of Toronto.
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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.
Xiaolin Wei, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital health interventions in people with Noncommunicable Diseases and COVID-19, run by University of Toronto 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 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: finished, as of the sponsor's last update on 29 Sep 2026. 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?
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?
Systolic blood pressure (mmHg) measured in the rural health center (time frame: At 12 months). 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 NCT05699369, 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 29 Sep 2026.