Effect of Mobile Communication on Congenital Ectopia Lentis Follow-up Adherence

Effect of WeChat Application Combined Phone Reminder on Follow-up Adherence Improvement in Congenital Ectopia Lentis Patients : A Randomized Controlled Trial

Regular follow-up is essential to successful management of congenital ectopia lentis, but it is often ignored by parents in China.

With rapid economic development, there are increasing numbers of mobile phone users that allow for communication applications to be used in medical care.

The investigators aimed to assess the potential of the smartphone application assisted medical service to increase patient compliance in attendance of follow-up after congenital ectopia lentis treatment.

Study Overview

• Status: Recruiting
• Conditions: Ectopia Lentis
• Intervention / Treatment: Other: smartphone application service and phone reminder

Detailed Description

Congenital ectopia lentis is a rare ophthalmic disease that seriously harms the physical and mental health of patients. Surgery is the only definite treatment at present. However, severe visual impairment is common in congenital ectopia lentis patients in China, and delayed presentation to hospital and late surgical treatment are found to be the major reasons.

In China, the messaging application WeChat has become the most popular communication tool. As most congenital ectopia lentis patients' parents are younger people, they are more likely to use technology, such as WeChat, in their daily lives. In addition, it allows ophthalmologists to utilize this communication application to relay health related information and reminders to patients. This makes it feasible to apply this smartphone application in improving attendance of follow-up visits.

In this trial, the investigators aimed to assess the potential of the smartphone application assisted medical service to increase patient compliance in attendance of follow-up after congenital ectopia lentis treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Zhongshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1. Identified with congenital lens dislocation after surgery and age ≤ 18 years old; 2. Parents were able to access a mobile phone and communicate via the smartphone application (WeChat); 3. Agree to participate in this study and sign the informed consent.

Exclusion Criteria:

• 1. With Other ophthalmic diseases such as glaucoma, uveitis and corneal disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: reminder intervention; On the basis of standard appointment, parents in intervention group will receive phone reminders at 4 days and 1 day before their scheduled appointments, and relevant scientific and educational knowledge will be relayed to them from the smartphone application at 1 week before appointments.	Other: smartphone application service and phone reminder; smartphone application service and phone reminder for appointments of parents of congenital ectopia lentis patients
NO_INTERVENTION: standard appointment; Patients will be required to attend follow-up appointments at 1 week, 1 month, 3 months after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
follow-up adherence at 3 months after surgery	the rates of attendance at 3 months (± 3 weeks) after surgery	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
follow-up adherence at 1 week after surgery	the rates of attendance at 1 week (± 2 days) after surgery	1 week
follow-up adherence at 1 month after surgery	the rates of attendance at 1 month (± 1 week) after surgery	1 month
best corrected visual acuity	measurement of best corrected visual acuity was carried out using a logarithm of the Minimum Angle of Resolution (logMAR) chart at the baseline and endline visits	3 months
incidence of complications	Including: postoperative high IOP, postoperative macular edema, knot/suture-related complications and so on	3 months
replacement rates of glasses	If the difference between the current refraction and the currently worn eyeglass prescription was greater than 2 diopters sphere and/or greater than 1 diopter cylinder, a new prescription was given	3 months
amblyopia therapy rate	the rate of amblyopia therapy during 3 months after surgery	3 months
secondary surgery rate	the rate of secondary surgery during 3 months after surgery	3 months
referral rate due to systemic diseases	referral rate due to abnormalities in skeletal system and cardiovascular system during 3 months after surgery	3 months
CEL knowledge score	change between baseline and endline scores on knowledge about CEL, including six choice questions concerning pathogenesis, symptoms and treatment of CEL	3 months

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications and helpful links

General Publications

• Lin H, Chen W, Luo L, Congdon N, Zhang X, Zhong X, Liu Z, Chen W, Wu C, Zheng D, Deng D, Ye S, Lin Z, Zou X, Liu Y. Effectiveness of a short message reminder in increasing compliance with pediatric cataract treatment: a randomized trial. Ophthalmology. 2012 Dec;119(12):2463-70. doi: 10.1016/j.ophtha.2012.06.046. Epub 2012 Aug 24.
• Chen T, Zhu W, Tang B, Jin L, Fu H, Chen Y, Wang C, Zhang G, Wang J, Ye T, Xiao D, Vignarajan J, Xiao B, Kanagasingam Y, Congdon N. A Mobile Phone Informational Reminder to Improve Eye Care Adherence Among Diabetic Patients in Rural China: A Randomized Controlled Trial. Am J Ophthalmol. 2018 Oct;194:54-62. doi: 10.1016/j.ajo.2018.07.006. Epub 2018 Jul 24.
• Lin J, Gong N, Cao Q, Zhou Y, Cai Y, Jin G, Young CA, Yang J, Wang Y, Zheng D. What hinders congenital ectopia lentis patients' follow-up visits? A qualitative study. BMJ Open. 2020 Mar 12;10(3):e030434. doi: 10.1136/bmjopen-2019-030434.
• Tan J, Christie A, Montalvo SK, Wallace C, Yan Y, Folkerts M, Yingling A, Sher D, Choy H, Jiang S, Westover KD. Automated Text Message Reminders Improve Radiation Therapy Compliance. Int J Radiat Oncol Biol Phys. 2019 Apr 1;103(5):1045-1052. doi: 10.1016/j.ijrobp.2018.11.050. Epub 2018 Nov 30.
• Bi J, Yang W, Hao P, Zhao Y, Wei D, Sun Y, Lin Y, Sun M, Chen X, Luo X, Li S, Zhang W, Wang X. WeChat as a Platform for Baduanjin Intervention in Patients With Stable Chronic Obstructive Pulmonary Disease in China: Retrospective Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Feb 2;9(2):e23548. doi: 10.2196/23548.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 5, 2022
• Primary Completion (ANTICIPATED): April 1, 2024
• Study Completion (ANTICIPATED): April 1, 2025

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (ACTUAL): November 28, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Congenital Abnormalities; Eye Abnormalities; Pathological Conditions, Anatomical; Lens Diseases; Lens Subluxation; Ectopia Lentis; Choristoma
• Other Study ID Numbers: IIT2022120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No