NCT03567226

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 25, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

June 25, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2018

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

5 months

First QC Date

May 29, 2018

Last Update Submit

January 14, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 weeks

Secondary Outcomes (1)

  • Time spent in moderate to vigorous physical activity

    5 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Behavioral: WeChat Group

Control Group

ACTIVE COMPARATOR

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

Behavioral: Counselling

Interventions

WeChat GroupBEHAVIORAL

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: 1. Daily/Weekly Reminders to exercise 2. Health education materials regarding glaucoma and general health and exercise 3. Motivational content 4. Surveys to gauge what information participants found most interesting and useful to help them exercise

Intervention Group
CounsellingBEHAVIORAL

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

Control Group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The affiliated eye hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Counseling

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • David Friedman, MD, MPH, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
  • Yuanbo Liang, MD, PhD

    Clinical & Epidemiological Eye Research Centre, The affiliated eye hospital of Wenzhou Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2018

First Posted

June 25, 2018

Study Start

June 25, 2018

Primary Completion

November 26, 2018

Study Completion

November 26, 2018

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations