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Testing the Effectiveness of Different Messaging Approaches to Increase Doctor Visits Amongst Individuals With Risk Factors for Diabetes

Primary Purpose

Type 2 Diabetes, Pre-diabetes

Status
Active
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Visit a doctor
Sponsored by
Wits Health Consortium (Pty) Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Members of Vitality who are also members of the Discovery Health medical plan and who have risk factors for diabetes but who have not previously been diagnosed with diabetes Risk factors are age ≥45years, overweight and obesity, family history of diabetes, hypertension or raised high blood pressure, low levels of physical activity, cardiovascular disease, and dyslipidemia. Exclusion Criteria: < 18 years >= 65 years Diagnosed with diabetes

Sites / Locations

  • Discovery Vitality

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Diabetes specialist

Someone like you

Vitality doctor

Arm Description

Message with a note from a diabetes specialist

Message with a note from "a person like you"

Message with a note from the Vitality doctor

Outcomes

Primary Outcome Measures

Fasting blood glucose (mmol/L)
Type 2 Diabetes
Glucose tolerance test (mmol/L)
Type 2 Diabetes
HbA1C(%)
Pre-Diabetes

Secondary Outcome Measures

Full Information

First Posted
February 1, 2023
Last Updated
March 30, 2023
Sponsor
Wits Health Consortium (Pty) Ltd
Collaborators
Discovery Vitality
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1. Study Identification

Unique Protocol Identification Number
NCT05755555
Brief Title
Testing the Effectiveness of Different Messaging Approaches to Increase Doctor Visits Amongst Individuals With Risk Factors for Diabetes
Official Title
Testing the Effectiveness of Different Messaging Approaches to Increase Doctor Visits to Confirm or Exclude a Diagnosis of Prediabetes or Diabetes Amongst Individuals With Risk Factors for Diabetes: A Randomised, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 4, 2022 (Actual)
Primary Completion Date
March 3, 2023 (Actual)
Study Completion Date
May 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wits Health Consortium (Pty) Ltd
Collaborators
Discovery Vitality

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 purpose of the research is to test the effectiveness of different messaging approaches to nudge members of Vitality and Discovery Health, with risk factors for diabetes (based on data from the Vitality Health Check and Vitality Age assessment), to visit a doctor and test for diabetes. The messages are based on concepts from behavioural economics that aim to make information on screening more salient by using the concept of social proof (person like you) and an authoritative source (a diabetes specialist and the Vitality doctor).
Detailed Description
Members of Vitality who are also members of the Discovery Health medical plan and who have risk factors for diabetes but who have not previously been diagnosed with diabetes will be eligible for the study. Subjects will be identified based on the Vitality Age assessment and the Vitality Health Check done in the previous year. The risk factors identified by these assessments and which are important for eligibility are age ≥45years, overweight and obesity, family history of diabetes, hypertension or raised high blood pressure, low levels of physical activity, cardiovascular disease, and dyslipidemia. It is estimated that approximately 5000 Vitality members will be eligible for the study. Only the actuarial team assigned to the study will have access to the data. Participants will de-identified and randomly allocated to the control and four intervention arms. Messages will be sent via email to them which addresses their specific health risks and measures they can take to address those risk. The messages will be in an encrypted PDF sent by email. In compliance with the POPIA Act, as a first step, participants will be asked to provide consent, by confirming their ID number, to share their individual risks information with them. Messages sent via email will have the same basic structure. All three of the experimental arm messages will include the following: The same subject line A description of their risk factors for diabetes A description of the benefits of visiting a doctor and getting screened for diabetes

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Pre-diabetes

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
5000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diabetes specialist
Arm Type
Experimental
Arm Description
Message with a note from a diabetes specialist
Arm Title
Someone like you
Arm Type
Experimental
Arm Description
Message with a note from "a person like you"
Arm Title
Vitality doctor
Arm Type
Experimental
Arm Description
Message with a note from the Vitality doctor
Intervention Type
Behavioral
Intervention Name(s)
Visit a doctor
Intervention Description
Test messages based on concepts from behavioural economics that aim to make information on screening more salient by using the concept of social proof (person like you) and an authoritative source (a diabetes specialist)
Primary Outcome Measure Information:
Title
Fasting blood glucose (mmol/L)
Description
Type 2 Diabetes
Time Frame
8 weeks
Title
Glucose tolerance test (mmol/L)
Description
Type 2 Diabetes
Time Frame
8 weeks
Title
HbA1C(%)
Description
Pre-Diabetes
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Members of Vitality who are also members of the Discovery Health medical plan and who have risk factors for diabetes but who have not previously been diagnosed with diabetes Risk factors are age ≥45years, overweight and obesity, family history of diabetes, hypertension or raised high blood pressure, low levels of physical activity, cardiovascular disease, and dyslipidemia. Exclusion Criteria: < 18 years >= 65 years Diagnosed with diabetes
Facility Information:
Facility Name
Discovery Vitality
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2007
Country
South Africa

12. IPD Sharing Statement

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Testing the Effectiveness of Different Messaging Approaches to Increase Doctor Visits Amongst Individuals With Risk Factors for Diabetes

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