See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
Study protocol
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: The prevalence of hypertension is high and increasing in China in recent years. The treatment and control of hypertension calls for long-term management beyond hospital, which is hard to implement in traditional care settings. Integrated care combined with information technology can promote high-quality healthcare services across the life-course. However, few studies have applied a customized integrated care model in community-based hypertension management in China, catering to the emerging "three-manager" mode. This study aims to identify the effectiveness of a pathway-driven eHealth-based integrated model that implemented as a full-featured telehealth system to facilitate standardized management of hypertension in China.
Methods: The trial has been designed as a one-year, non-blinded superiority trial with two parallel groups. A total of 402 hypertensive patients who meet the eligibility criteria will be recruited and randomized with a 1:1 allocation. All the participants will receive a mobile device for self-management, which is a part of our telehealth system. Participants in the control group will only use the device for BP measurement and receive regular follow-ups from care providers according to the guidelines. Participants in the intervention group will gain full access to the system and receive intervention based on the proposed model (a well-designed coordinated care pathway consisting of 9 tasks). Outcomes will be measured mainly on three occasions (at inclusion, at 6 months and at 12 months). The primary outcome is mean change in systolic blood pressure over a 12-month period. Secondary outcomes include changes in diastolic blood pressure, biochemical indexes related to hypertension, lifestyles, self-management adherence and hypertension awareness, as well as work efficiency of care providers.
Discussion: This study aims to investigate whether a pathway-driven eHealth-based integrated care model based on the "three-manager" mode will improve hypertension control in China. Success of the model would help improve the quality of present community-based management procedures and benefit more patients with uncontrolled hypertension.
Trial registration: Chinese Clinical Trial Registry ChiCTR1900027645, registered on November 22, 2019.
Keywords
hypertension management; integrated care; pathway; community; telehealth; study protocol; randomized controlled trial
Figure 1
Figure 2
Figure 3
Figure 4
This is a list of supplementary files associated with this preprint. Click to download.
Loading...
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
Version 2
Posted 14 Oct, 2020
No community comments so far
Editorial decision: Accept
On 03 Jan, 2021
Reviewer #2 agreed
On 31 Oct, 2020
Review #2 received
Received 31 Oct, 2020
Review #1 received
Received 29 Oct, 2020
Reviewers invited
Invitations sent on 28 Oct, 2020
Reviewer #1 agreed
On 28 Oct, 2020
Editor assigned
On 05 Oct, 2020
Submission checks complete
On 04 Oct, 2020
No comments provided
Reviewer #2 agreed
On 22 Sep, 2020
Review #2 received
Received 22 Sep, 2020
Editorial decision: Minor revision
On 22 Sep, 2020
Reviewer #1 agreed
On 15 May, 2020
Review #1 received
Received 15 May, 2020
Reviewers invited
Invitations sent on 14 May, 2020
Editor assigned
On 29 Feb, 2020
Submission checks complete
On 26 Feb, 2020
First submitted
On 07 Feb, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Learn more about our company.
A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
Version 2
Posted 14 Oct, 2020
No community comments so far
Editorial decision: Accept
On 03 Jan, 2021
Reviewer #2 agreed
On 31 Oct, 2020
Review #2 received
Received 31 Oct, 2020
Review #1 received
Received 29 Oct, 2020
Reviewers invited
Invitations sent on 28 Oct, 2020
Reviewer #1 agreed
On 28 Oct, 2020
Editor assigned
On 05 Oct, 2020
Submission checks complete
On 04 Oct, 2020
No comments provided
Reviewer #2 agreed
On 22 Sep, 2020
Review #2 received
Received 22 Sep, 2020
Editorial decision: Minor revision
On 22 Sep, 2020
Reviewer #1 agreed
On 15 May, 2020
Review #1 received
Received 15 May, 2020
Reviewers invited
Invitations sent on 14 May, 2020
Editor assigned
On 29 Feb, 2020
Submission checks complete
On 26 Feb, 2020
First submitted
On 07 Feb, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
Background: The prevalence of hypertension is high and increasing in China in recent years. The treatment and control of hypertension calls for long-term management beyond hospital, which is hard to implement in traditional care settings. Integrated care combined with information technology can promote high-quality healthcare services across the life-course. However, few studies have applied a customized integrated care model in community-based hypertension management in China, catering to the emerging "three-manager" mode. This study aims to identify the effectiveness of a pathway-driven eHealth-based integrated model that implemented as a full-featured telehealth system to facilitate standardized management of hypertension in China.
Methods: The trial has been designed as a one-year, non-blinded superiority trial with two parallel groups. A total of 402 hypertensive patients who meet the eligibility criteria will be recruited and randomized with a 1:1 allocation. All the participants will receive a mobile device for self-management, which is a part of our telehealth system. Participants in the control group will only use the device for BP measurement and receive regular follow-ups from care providers according to the guidelines. Participants in the intervention group will gain full access to the system and receive intervention based on the proposed model (a well-designed coordinated care pathway consisting of 9 tasks). Outcomes will be measured mainly on three occasions (at inclusion, at 6 months and at 12 months). The primary outcome is mean change in systolic blood pressure over a 12-month period. Secondary outcomes include changes in diastolic blood pressure, biochemical indexes related to hypertension, lifestyles, self-management adherence and hypertension awareness, as well as work efficiency of care providers.
Discussion: This study aims to investigate whether a pathway-driven eHealth-based integrated care model based on the "three-manager" mode will improve hypertension control in China. Success of the model would help improve the quality of present community-based management procedures and benefit more patients with uncontrolled hypertension.
Trial registration: Chinese Clinical Trial Registry ChiCTR1900027645, registered on November 22, 2019.
Figure 1
Figure 2
Figure 3
Figure 4
This is a list of supplementary files associated with this preprint. Click to download.
Loading...