HypertensionEarly Phase 1NCT03988894
mDASHNa-CC APP to Support a Healthy Diet and Hypertension Control for Chinese Canadian Seniors
A Early Phase 1 study testing mDASHNa App in people with Hypertension and Diet, Healthy, run by University of Toronto.
Trial summary
The aim of this proposed study is to translate the Dietary Approach to Stop Hypertension with Sodium (Na) Reduction for Chinese Canadian (DASHNa-CC), a classroom-based antihypertensive dietary educational intervention, to an innovative smartphone app (mDASHNa-CC) to enable Chinese Canadian seniors' access to this… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypertension, Diet, Healthy
- What is being tested?
- mDASHNa App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2020to 30 Jun 2021
- Phase
- Early Phase 1
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- have a systolic blood pressure higher than 140 mmHg, or a diastolic blood pressure higher than 90mmHg, or are on antihypertensive medications, based on pre-intervention baseline assessment
- are able to understand (listen) and speak in Mandarin or Cantonese, read and write in Chinese
- have access to a smartphone
Who cannot join
- have special dietary requirements
- are a household member of another mDASHNa-CC participant
- plan to leave the area prior to the anticipated end of study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Design, Usability Testing, and Feasibility Testing of a Smartphone App (mDASHNa-CC) to Support Healthy Diet and Hypertension Control for Chinese Canadian Seniors
The aim of this proposed study is to translate the Dietary Approach to Stop Hypertension with Sodium (Na) Reduction for Chinese Canadian (DASHNa-CC), a classroom-based antihypertensive dietary educational intervention, to an innovative smartphone app (mDASHNa-CC) to enable Chinese Canadian seniors' access to this antihypertensive dietary intervention anytime, regardless of where they are.
- Conditions
- Hypertension, Diet, Healthy
- Being tested
- mDASHNa App
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mDASHNa AppDevice
The functions of the app will include: (a) antihypertensive dietary education; (b) dietary self-assessment; (c) automatic feedback according to dietary self-assessment; (d) blood pressure monitoring; and (e) automatic feedback according to blood pressure data.
| Study group | Role | What they receive |
|---|---|---|
| Control: Usual Care | No intervention | All participants will (a) receive a general hypertension health education booklet from the Heart and Stroke Foundation of Ontario;(b) be encouraged to see their family physicians or primary health care providers regarding their blood pressure status; those who do not have a primary health care provider will be referred to a walk-in clinic or a community health centre; and (c) have access to family physicians, tele-health, emergency care, hospital and other health care facilities in the Greater Toronto Area as required. |
| Intervention: mDASHNa-CC app use | Active comparator | In addition to usual care, those participants randomized to the intervention group will be offered use of the app.Then, they will load the app in their smartphones and be requested to review educational contents, conduct dietary self-assessment, and monitor blood pressure for 8 weeks.By the end of eight weeks post randomization, seniors will be prompted by phone using an audible alert to complete the app Evaluation Questionnaire on the smartphone, which ascertains likes and dislikes with the app. Receives: Device: mDASHNa App |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of systolic Blood Pressure from baseline to eight weeks after randomization
Systolic blood pressures will be measured by the home blood pressure monitor, Omron BP785, whose validity and reliability have been tested
Measured: eight weeks after randomization
change of diastolic Blood Pressure from baseline to eight weeks after randomization
diastolic blood pressures will be measured by the home blood pressure monitor, Omron BP785, whose validity and reliability have been tested
Measured: eight weeks after randomization
change of body weight from baseline to eight weeks after randomization
Weight will be measured by an electronic body weight scale (Rubbermaid® Digital Utility Scale, Model number H-479, Capacity/Accuracy 400 lbs * 0.5 lb)
Measured: eight weeks after randomization
change of waist circumference from baseline to eight weeks after randomization
Waist circumference will be measured by measurement tape following proper technique
Measured: eight weeks after randomization
change of Health-related Quality of Life from baseline to eight weeks after randomization
Health-related quality of life will be measured by Medical Outcomes Study 36-Item Short Form version two. The SF-36v2 required ten minutes to complete and consisted of 36 items and eight domains, which could be grouped into physical and mental component summaries. All domains were scored on a scale ranging from 0 to 100, wherein 0 represented the worst overall health status and 100 the best health status.
Measured: eight weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start10 Jan 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
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 HypertensionStudies 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pilot two-group (1:1) randomized controlled trial with a sample size of 60 (block of 20) in a Chinese Canadian community in the Greater Toronto Area, Ontario, Canada.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Zou, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988894
- Sponsor's protocol ID
- 02579746
- Status last verified
- Jun 2019
- First submitted
- 8 Jun 2019
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zou P, Stinson J, Parry M, Dennis CL, Yang Y, Lu Z. A Smartphone App (mDASHNa-CC) to Support Healthy Diet and Hypertension Control for Chinese Canadian Seniors: Protocol for Design, Usability and Feasibility Testing. JMIR Res Protoc. 2020 Apr 2;9(4):e15545. doi: 10.2196/15545.
PubMed 32238343
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design, Usability Testing, and Feasibility Testing of a Smartphone App (mDASHNa-CC) to Support Healthy Diet and Hypertension Control for Chinese Canadian Seniors
- ClinicalTrials.gov ID
- NCT03988894
- Acronym / sponsor ID
- 02579746
- Conditions
- Hypertension, Diet, Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 10 Jan 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 18 Jun 2019 (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 aim of this proposed study is to translate the Dietary Approach to Stop Hypertension with Sodium (Na) Reduction for Chinese Canadian (DASHNa-CC), a classroom-based antihypertensive dietary educational intervention, to an innovative smartphone app (mDASHNa-CC) to enable Chinese Canadian seniors' access to this antihypertensive dietary intervention anytime, regardless of where they are.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A pilot two-group (1:1) randomized controlled trial with a sample size of 60 (block of 20) in a Chinese Canadian community in the Greater Toronto Area, Ontario, Canada.
| Arm | Type | Receives |
|---|---|---|
| Control: Usual Care | No intervention | –All participants will (a) receive a general hypertension health education booklet from the Heart and Stroke Foundation of Ontario;(b) be encouraged to see their family physicians or primary health care providers regarding their blood pressure status; those who do not have a primary health care provider will be referred to a walk-in clinic or a community health centre; and (c) have access to family physicians, tele-health, emergency care, hospital and other health care facilities in the Greater Toronto Area as required. |
| Intervention: mDASHNa-CC app use | Active comparator | Device: mDASHNa AppIn addition to usual care, those participants randomized to the intervention group will be offered use of the app.Then, they will load the app in their smartphones and be requested to review educational contents, conduct dietary self-assessment, and monitor blood pressure for 8 weeks.By the end of eight weeks post randomization, seniors will be prompted by phone using an audible alert to complete the app Evaluation Questionnaire on the smartphone, which ascertains likes and dislikes with the app. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- have a systolic blood pressure higher than 140 mmHg, or a diastolic blood pressure higher than 90mmHg, or are on antihypertensive medications, based on pre-intervention baseline assessment
- are able to understand (listen) and speak in Mandarin or Cantonese, read and write in Chinese
- have access to a smartphone
Key exclusion criteria (3 listed)
- have special dietary requirements
- are a household member of another mDASHNa-CC participant
- plan to leave the area prior to the anticipated end of study
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 |
|---|---|---|
| mDASHNa AppThe functions of the app will include: (a) antihypertensive dietary education; (b) dietary self-assessment; (c) automatic feedback according to dietary self-assessment; (d) blood pressure monitoring; and (e) automatic feedback according to blood pressure data. | Device | Intervention: mDASHNa-CC app use |
Primary outcome
change of systolic Blood Pressure from baseline to eight weeks after randomization
Time frame: eight weeks after randomization
Systolic blood pressures will be measured by the home blood pressure monitor, Omron BP785, whose validity and reliability have been tested
change of diastolic Blood Pressure from baseline to eight weeks after randomization
Time frame: eight weeks after randomization
diastolic blood pressures will be measured by the home blood pressure monitor, Omron BP785, whose validity and reliability have been tested
change of body weight from baseline to eight weeks after randomization
Time frame: eight weeks after randomization
Weight will be measured by an electronic body weight scale (Rubbermaid® Digital Utility Scale, Model number H-479, Capacity/Accuracy 400 lbs * 0.5 lb)
change of waist circumference from baseline to eight weeks after randomization
Time frame: eight weeks after randomization
Waist circumference will be measured by measurement tape following proper technique
change of Health-related Quality of Life from baseline to eight weeks after randomization
Time frame: eight weeks after randomization
Health-related quality of life will be measured by Medical Outcomes Study 36-Item Short Form version two. The SF-36v2 required ten minutes to complete and consisted of 36 items and eight domains, which could be grouped into physical and mental component summaries. All domains were scored on a scale ranging from 0 to 100, wherein 0 represented the worst overall health status and 100 the best health status.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Derived from this study: PubMed 32238343Zou P, Stinson J, Parry M, Dennis CL, Yang Y, Lu Z. A Smartphone App (mDASHNa-CC) to Support Healthy Diet and Hypertension Control for Chinese Canadian Seniors: Protocol for Design, Usability and Feasibility Testing. JMIR Res Protoc. 2020 Apr 2;9(4):e15545. doi: 10.2196/15545.
- 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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing mDASHNa App in people with Hypertension and Diet, Healthy, run by University of Toronto.
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 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: status not confirmed, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Ping Zou (14166427003, pingz@nipissingu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of systolic Blood Pressure from baseline to eight weeks after randomization (time frame: eight weeks after randomization). The study lists 5 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 NCT03988894, 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 18 Jun 2019.