NCT02328456

Brief Summary

The purpose of the study is to use a randomized controlled design to determine the impact of a SMS messaging associated with free eye drops intervention on the following outcomes among patients after trabeculectomy surgery in rural China.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
209

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

April 15, 2016

Status Verified

April 1, 2016

Enrollment Period

11 months

First QC Date

December 23, 2014

Last Update Submit

April 14, 2016

Conditions

GlaucomaAdherence

Outcome Measures

Primary Outcomes (1)

  • Not-attended rate

    Compare the SMS and free eye drops patient not-attend rate with the control group to show the impact of SMS reminder associated with free eye drops on the adherence with scheduled follow-up visit

    up to 1 year

Secondary Outcomes (2)

  • Knowledge and Attitudes about glaucoma, glaucoma surgery and importance of follow-up using a questionnaire

    up to 1 year

  • Additional factors potentially associated with post-operative follow-up using a patient questionnaire

    up to 1 year

Study Arms (2)

SMS and free eye drops group

OTHER

the patient after trabeculectomy surgery in the SMS associated with free eye drops group will receive free eye drops and a SMS reminder message about the revisit time.

Other: SMS and free eye drops

the control group

NO INTERVENTION

the patient after trabeculectomy surgery in the control group won't get any free eye drop and reminder message before the appointment.

Interventions

SMS and free eye dropsOTHER

The SMS reminder message will sent to the SMS associated with free eye drops group patients 1 week and 1 day before there appointment to remind them the exact time and address of the revisit appointment.The eye drops will be offered free to the the SMS associated with free eye drops group patients when they revisit on time.

SMS and free eye drops group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All the patients after trabeculectomy surgery in 4 cooperated rural hospitals

You may not qualify if:

  • Both the patient and his/her caretakers don't have cellphone or the one who has cellphone but don't know how to use the SMS function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blindness Preventment and Treatment Department

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

  • Yang K, Jin L, Li L, Zeng S, Wei R, Li G, Man P, Congdon N. Interventions to Promote Follow-up After Trabeculectomy Surgery in Rural Southern China: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Oct 1;134(10):1135-1141. doi: 10.1001/jamaophthalmol.2016.2819.

    PMID: 27541442DERIVED

MeSH Terms

Conditions

Glaucoma

Interventions

Spermine Synthase

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Alkyl and Aryl TransferasesTransferasesEnzymesEnzymes and Coenzymes

Study Officials

  • Nathan G Congdon, MD,MPH

    China,Guangdong,Blindness Preventment and Treatment Department,Zhongshan Ophthalmic Center,510060

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
vice directior,Blindness Prevention and Treatment Department

Study Record Dates

First Submitted

December 23, 2014

First Posted

December 31, 2014

Study Start

December 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

April 15, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)