Recruiting

Observational Study

Sponsor:

Women's College Hospital

Code:

NCT03927859

Conditions

Diabetes Mellitus, Type 2

Diabetes Mellitus, Type 1

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

a mail letter, a phone call and a phone call plus mailed letter

Study Details

Brief summary:

It is recommended that people with diabetes have their eyes screened for retinopathy every 1-2 years. Retinopathy can lead to visual impairment and blindness, but early detection through regular retinal screening can help to prevent this. Many Ontarians with diabetes have not been receiving regular screening. One possible way to get more people screened for retinopathy involves tele-retinal screening using teleophthalmology (TOP), where patients can have their eyes screened in their local clinic or a site nearby. In this project, we are testing 3 patient interventions: mailing a letter, phone call or an option to bundle their screening with other diabetic care services (e.g. foot care exam) and examine the impact of these various interventions alone or in combination with each other.

Conditions

Diabetes Mellitus, Type 2

Diabetes Mellitus, Type 1

Study ID

NCT03927859

Start date

Jul 5, 2018

Status verified date

Apr, 2019

Completion date

Aug 30, 2019

Anticipated

Primary completion date

Jun 30, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Only patients diagnosed with Type I or Type II Diabetes with no evidence in their medical records of a screening within the last 2 years will be included in the study and only individuals 18 years of age or older will be included.

Exclusion Criteria:

Patients screened within the last year. In addition, individuals who cannot speak English will be excluded from the study to minimize additional workload placed on administrative staff.

Study Design

Enrollment

420 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Mailing Letter

Patients assigned to this arm, in which a letter is mailed out will receive 2 pamphlets in the mail. One pamphlet described the teleophthalmology program and the other pamphlet was designed by the Canadian Association of Ophthalmologists and describes what DR is and why screening is important. The letter will also contain contact information about the closest TOP to the area of the PCP practice.

active comparator: Phone call

Administrative staff on site of each practice will contact all patients assigned to this arm by a phone call.

The patient will be informed that they are calling from the family health practice that the patient belongs to. The reason for the call will be that the patient has been identified as somebody who is likely overdue for a screening test. Patients will be asked if they have had a screening test done recently, and if not, they will be offered an appointment. Patients that refuse an appointment, will be politely probed for reasons and attempts will be made to provide them with information on potential solutions to these barriers (e.g. patients working 9-5 on weekdays will be informed that they can access TOP on evenings). The call will also be used as an opportunity to inform patients about the importance of screening.Three attempts will be made to reach each patient. Only a single voicemail message will be left, when the possibility is available.

active comparator: Mail + Phone call

Patients assigned to this arm will first have letters mailed out to them (identical to the ones mailed out in the letter only arm). A week later, the letter will be followed up by a phone call as per the phone only arm. Patients will be asked if they have already booked, and if not, will be provided with information about the program as per the phone call script in the phone only arm.

no intervention: Control

No intervention will be offered to patients in this arm.

Interventions

a mail letter, a phone call and a phone call plus mailed letter

All patients will be administered an intervention that will contain one or more of 3 possible interventions (a mail letter, a phone call and a mail plus phone call). Some patients will also be assigned into a condition where none of the interventions will be present.

Patients at Black Creek CHC will only be offered a phone or a phone plus incentive intervention or a no intervention.

Primary outcome measure

  • Number of bookings made through the TOP program [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Vess Stamenova, PhD

416-323-6400vess.stamenova@wchospital.ca

Nike Onabajo, MSc

4163236400nike.onabajo@wchospital.ca

Locations

Black Creek Community Health Centre

Recruiting

Toronto, Ontario, Canada, M3M 1A4

Contacts

Doris Forlemu-Kamwa

4162498000Doris.Forlemu-Kamwa@bcchc.com

More Information

Sponsor

Women's College Hospital

Last update posted

Apr 25, 2019

Last verified

Apr, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Women's College Hospital on 2019-04-25.