mDASHNa-CC APP to Support a Healthy Diet and Hypertension Control for Chinese Canadian Seniors

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Primary Purpose

Status

Unknown status

Phase

Early Phase 1

Locations

Study Type

Interventional

Intervention

mDASHNa App

About this trial

This is an interventional supportive care trial for Hypertension

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control: Usual Care

Intervention: mDASHNa-CC app use

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

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

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)

change of waist circumference from baseline to 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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03988894

First Posted

June 8, 2019

Last Updated

June 15, 2019

Sponsor

University of Toronto

1. Study Identification

Unique Protocol Identification Number

NCT03988894

Brief Title

mDASHNa-CC APP to Support a Healthy Diet and Hypertension Control for Chinese Canadian Seniors

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 10, 2020 (Anticipated)

Primary Completion Date

December 1, 2020 (Anticipated)

Study Completion Date

June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief 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 antihypertensive dietary intervention anytime, regardless of where they are.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Diet, Healthy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control: Usual Care

Arm Type

No Intervention

Arm Description

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.

Arm Title

Intervention: mDASHNa-CC app use

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

mDASHNa App

Intervention Description

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.

Primary Outcome Measure Information:

Title

change of systolic Blood Pressure from baseline to eight weeks after randomization

Description

Systolic blood pressures will be measured by the home blood pressure monitor, Omron BP785, whose validity and reliability have been tested

Time Frame