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Leveraging WeChat Social-Media and Messaging Platform to Increase Physical Activity in Chinese Glaucoma Patients

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
WeChat Group
Counselling
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Glaucoma

Eligibility Criteria

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

Inclusion Criteria:

  • Glaucoma diagnosis
  • Age 40 years and above
  • Ability to sign informed consent
  • Ability to use WeChat

Exclusion Criteria:

  • Patients with severe heart, lung, or kidney disease which may prevent them from exercising
  • Patients who self-report walking 12,000 steps or more per day

Sites / Locations

  • The affiliated eye hospital of Wenzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control Group

Arm Description

The intervention group will be enrolled into a WeChat Group to receive reminders to exercise and health education materials.

Controls will receive a handout telling them to increase walking and that walking may be helpful for the eye at the return visit.

Outcomes

Primary Outcome Measures

Efficacy of using WeChat as an intervention to increase physical activity in Chinese glaucoma patients
The primary outcome variable will be the number of daily steps taken over the course of one month for each participant. This outcome will be measured by having participants wear the Accelerometer WGT3X-BT, from which we can collect steps data. From this primary outcome measure we will also assess the change in number of steps taken comparing the first week to the following month after the intervention. Assuming mean enrollment number of steps per day is 9,302.29, we can detect an average increase of 2,500 steps per day with alpha set to 0.05 with 80% power.

Secondary Outcome Measures

Time spent in moderate to vigorous physical activity
We will also analyze the time spent in moderate to vigorous physical activity.

Full Information

First Posted
May 29, 2018
Last Updated
January 14, 2019
Sponsor
Johns Hopkins University
Collaborators
Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03567226
Brief Title
Leveraging WeChat Social-Media and Messaging Platform to Increase Physical Activity in Chinese Glaucoma Patients
Official Title
Leveraging WeChat Social-Media and Messaging Platform to Increase Physical Activity in Chinese Glaucoma Patients: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 25, 2018 (Actual)
Primary Completion Date
November 26, 2018 (Actual)
Study Completion Date
November 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Wenzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The positive effects of exercise on ocular health are known, but modern lifestyles have made it difficult to incorporate physical activity into the daily lives of the Chinese population. Recent studies suggest that exercise plays an important role in lowering intraocular pressure (IOP) by protecting retinal ganglion cells (RGCs) in glaucoma patients as well as other potential neuroprotective benefits. Increasing the amount of physical activity within the Chinese glaucoma population may have marked effects on health outcomes and coincides with the Chinese government's efforts to make exercise an urgent public health priority. There is a need for innovative, cost-effective, and proven interventions to promote exercise behavior change and social media platforms may be able to fill this niche. WeChat is China's largest and most frequently used social media and messaging application with an estimated 570 million users. The platform has been found to be a useful tool in healthcare settings to promote weight-loss, health literacy, and patient adherence in Chinese populations. This study is a 5-weeks randomized control trial with three total study visits. 80 patients from an academic glaucoma clinic in Wenzhou Medical College will be randomized into two groups. The intervention group will be enrolled into an Official WeChat Group and receive periodic reminders to exercise, health education materials, and motivational incentives. The control group will receive weekly reminders and leaflets at the first clinic visit. Patients' daily step data will be monitored using an Accelerometer WGT3X-BT. The intervention duration will include an initial clinic visit, a one-week follow-up after wearing the accelerometer, and then a subsequent one-month follow-up visit after wearing the accelerometer. At the one-week visit the patient will be randomized and at the subsequent one-month visit there will be a close-out discussion about the study. In addition to collecting step data at clinic visits, investigators will also measure patients' visual field tests, optical coherence tomography angiography (angio-OCT), and intraocular pressure (IOP) using Goldmann Tonometry. The investigators' hypothesis is that using an Official WeChat Patient Group will be a robust and effective stimulus to increase physical exercise.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The intervention group will be enrolled into a WeChat Group to receive reminders to exercise and health education materials.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Controls will receive a handout telling them to increase walking and that walking may be helpful for the eye at the return visit.
Intervention Type
Behavioral
Intervention Name(s)
WeChat Group
Intervention Description
Consenting participants will be randomized to either the intervention or the control arm after successfully wearing an accelerometer for one week. The WeChat Group will be a community forum to share information, encourage each other, and receive communications from the study team. In addition, the study team will disseminate the following information through the group: Daily/Weekly Reminders to exercise Health education materials regarding glaucoma and general health and exercise Motivational content Surveys to gauge what information participants found most interesting and useful to help them exercise
Intervention Type
Behavioral
Intervention Name(s)
Counselling
Intervention Description
Study participants in the control group will receive a handout telling them to increase walking and will be counseled that walking may be helpful for the eye at the return visit
Primary Outcome Measure Information:
Title
Efficacy of using WeChat as an intervention to increase physical activity in Chinese glaucoma patients
Description
The primary outcome variable will be the number of daily steps taken over the course of one month for each participant. This outcome will be measured by having participants wear the Accelerometer WGT3X-BT, from which we can collect steps data. From this primary outcome measure we will also assess the change in number of steps taken comparing the first week to the following month after the intervention. Assuming mean enrollment number of steps per day is 9,302.29, we can detect an average increase of 2,500 steps per day with alpha set to 0.05 with 80% power.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Time spent in moderate to vigorous physical activity
Description
We will also analyze the time spent in moderate to vigorous physical activity.
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Glaucoma diagnosis Age 40 years and above Ability to sign informed consent Ability to use WeChat Exclusion Criteria: Patients with severe heart, lung, or kidney disease which may prevent them from exercising Patients who self-report walking 12,000 steps or more per day
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Friedman, MD, MPH, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yuanbo Liang, MD, PhD
Organizational Affiliation
Clinical & Epidemiological Eye Research Centre, The affiliated eye hospital of Wenzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The affiliated eye hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

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Leveraging WeChat Social-Media and Messaging Platform to Increase Physical Activity in Chinese Glaucoma Patients

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