PrediabetesINVENTNCT03403231
INcreasing Veteran EngagemeNT to Prevent Diabetes (INVENT)
A study testing INVENT Secure Messaging Intervention in people with Prediabetes, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study will evaluate a VA MyHealtheVet Secure Messaging intervention that uses different intervention messaging strategies designed to increase engagement in behaviors to prevent type 2 diabetes. The investigators will enroll 144 eligible Veterans into a 12-week MyHealtheVet Secure Messaging intervention. Read more about this study
- Who is it for?
- Ages Up to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes
- What is being tested?
- INVENT Secure Messaging Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- HbA1c test within the past 6 months that meets the ADA/CDC requirements for prediabetes.
- Currently registered in the VA's MyHealtheVet Secure Messaging System
- Receiving care within the Ann Arbor VA Healthcare System
Who cannot join
- Completed more than 4 VA MOVE! classes in the last year (or other evidence of another recent weight loss program)
- Are trying to lose weight and are very physically active
- Are >75 years of age
- Are pregnant or plan to be
- Are taking Metformin
- Have participated in the FINDIT study (this study's predecessor under the same grant funding)
Show all 16Show fewer
- Have been hospitalized or received rehab for stroke or myocardial infarction within past 6 months
- Have received chemotherapy for cancer in the past 6 months
- Self-report or have any International Classification of Diseases (ICD-9/10) codes for:
- Diabetes
- Dementia
- Major functional limitations
- Cirrhosis
- Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 4 chronic obstructive pulmonary disease (COPD)
- End stage renal disease (ESRD)
- New York Heart Association (NYHA) class III or IV congestive heart failure (CHF)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
About this study
Official title: INcreasing Veteran EngagemeNT to Prevent Diabetes (INVENT) (CDA 13-267)
This study will evaluate a VA MyHealtheVet Secure Messaging intervention that uses different intervention messaging strategies designed to increase engagement in behaviors to prevent type 2 diabetes.
The investigators will enroll 144 eligible Veterans into a 12-week MyHealtheVet Secure Messaging intervention. Eligible Veterans include those who are currently using MyHealtheVet secure messaging, meet inclusion/exclusion criteria, and have received an HbA1c test within the last 6 months that meets the ADA/CDC classification for prediabetes. Study participants will be surveyed about their engagement in behaviors to prevent TDM2 and mediators of this engagement. After completing a baseline survey, participants will be randomly assigned to receive different novel presentations of information about ways to prevent T2DM through both Secure Messaging and US Mail. The investigators will test the 5 presentations that each: (1) represent an innovative approach from behavioral economics or health psychology with great promise to increase engagement in behaviors to prevent T2DM among patients with prediabetes; and (2) have not been tested in this setting.
Read the detailed description
There is tremendous national enthusiasm for translating and disseminating efficacious strategies to prevent type 2 diabetes mellitus (T2DM). Yet, little attention has been devoted to how the investigators can better leverage the processes through which patients receive information about prevention of T2DM to better engage them in such prevention. Further, despite efforts to disseminate structured programs, many patients at high risk for developing T2DM may still be unable or unwilling to access them. In these cases, increasing patient engagement in individually directed lifestyle change or pharmacotherapy is critical. Strategies developed in the fields of behavioral economics and health psychology hold significant promise for improving Veteran engagement in each of these approaches. To date, however, these strategies have rarely been translated into real-world settings where they could benefit Veterans. This novel work will address this critical gap and could transform communication with Veterans about prevention in ways that will improve their health outcomes.
The following 5 strategies will be implemented in the weekly messages that study participants will receive: (1) tailoring to aspirations in life; (2) implementation intentions; (3) preference checklists; (4) urgency framing; (5) social norms. The investigators will implement these strategies alone and in combination in a 16-arm factorial design experiment.
- Conditions
- Prediabetes
- Being tested
- INVENT Secure Messaging Intervention
- Keywords
- Veterans, Type 2 diabetes mellitus, Prediabetes, Secure Messaging, Health Promotion, Prevention and Control, Motivation
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INVENT Secure Messaging InterventionBehavioural
We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Stock messages only | Active comparator | Participants will only receive the stock messages that encourage following recommended behaviors for reducing the risk for developing diabetes. Receives: Behavioral: INVENT Secure Messaging Intervention |
| Arm 2: Urgency frame message strategy | Experimental | Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the urgency frame message strategy. Receives: Behavioral: INVENT Secure Messaging Intervention |
| Arm 3: Social norm message strategy | Experimental | Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the social norm messaging strategy. Receives: Behavioral: INVENT Secure Messaging Intervention |
| Arm 4: Urgency frame and social norm strategies | Experimental | Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the urgency frame and social norm messaging strategies. Receives: Behavioral: INVENT Secure Messaging Intervention |
| Arm 5: Implementation Intentions and Urgency Frame | Experimental | Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the implementation intentions and urgency frame messaging strategies. Receives: Behavioral: INVENT Secure Messaging Intervention |
| Arm 6: Implementation Intentions and Social Norm | Experimental | Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the implementation intentions and social norm messaging strategies. Receives: Behavioral: INVENT Secure Messaging Intervention |
| Arm 7: Implementation Intentions, Urgency Frame & Social Norm | Experimental | Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the implementation intentions, urgency frame, and social norm messaging strategies. Receives: Behavioral: INVENT Secure Messaging Intervention |
| Arm 8: Implementation Intentions | Experimental | Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the implementation intentions messaging strategy. Receives: Behavioral: INVENT Secure Messaging Intervention |
| Arm 9: Preference Checklists and Urgency Frame | Experimental | Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the preference checklists and urgency frame messaging strategies. Receives: Behavioral: INVENT Secure Messaging Intervention |
| Arm 10: Preference Checklists and Social Norms | Experimental | Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the preference checklists and social norm messaging strategies. Receives: Behavioral: INVENT Secure Messaging Intervention |
| Arm 11: Preference Checklists, Urgency Frame & Social Norm | Experimental | Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the preference checklists, urgency frame, and social norm messaging strategies. Receives: Behavioral: INVENT Secure Messaging Intervention |
| Arm 12: Preference Checklists | Experimental | Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the preference checklists messaging strategy. Receives: Behavioral: INVENT Secure Messaging Intervention |
| Arm 13: Tailored Aspirations and Urgency Frame | Experimental | Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the tailored aspirations and urgency frame messaging strategies. Receives: Behavioral: INVENT Secure Messaging Intervention |
| Arm 14: Tailored Aspirations and Social Norm | Experimental | Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the tailored aspirations and social norm messaging strategies. Receives: Behavioral: INVENT Secure Messaging Intervention |
| Arm 15: Tailored Aspirations, Urgency Frame & Social Norm | Experimental | Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the tailored aspirations, urgency frame, and social norm messaging strategies. Receives: Behavioral: INVENT Secure Messaging Intervention |
| Arm 16: Tailored Aspirations | Experimental | Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the tailored aspirations messaging strategy. Receives: Behavioral: INVENT Secure Messaging Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement in Recommended Behaviors to Prevent Type 2 Diabetes
The investigators will use survey and medical record data to evaluate changes in participants' engagement in recommended behaviors to prevent type 2 diabetes.
Measured: 3 months
Secondary outcomes (8)
Motivation to Prevent Type 2 Diabetes
The investigators will use survey data to evaluate mean change in motivation level to prevent diabetes between baseline and 3-months. The Treatment Self-Regulation Questionnaire (TSRQ) was included in the survey and respondents were asked about their level of motivation from 1 (Not at all motivated) to 10 (Highly motivated).
Measured: 3 months
Importance of Preventing Type 2 Diabetes
The investigators will use survey data to evaluate mean changes in level of importance of preventing diabetes from baseline to 3 months. The Treatment Self-Regulation Questionnaire (TSRQ) was included in the survey and respondents were asked about their level of perceived importance from 1 (Not at all important) to 10 (Extremely important).
Measured: 3 months
Use of Medication for T2DM Prevention
The investigators will use medical record data and survey data to evaluate whether participants began the use of medication for T2DM prevention from baseline to 3 months.
Measured: 3 months
Perception for Risk for T2DM
The investigators will use survey data to evaluate mean changes in perception of risk for T2DM from baseline to 3 months. The Adriaanse T2DM Risk Perception Scale, which was included in the survey, measured self-assessed risk perception from 0 denoting no choice of developing T2DM to 100 denoting absolute confidence in developing T2DM
Measured: 3 months
Knowledge of Strategies to Prevent T2DM
The investigators will use survey data to evaluate changes in knowledge of strategies to prevent Type 2 Diabetes between baseline and 3-month assessment. Respondents were given 3 open-ended questions to report things they could do to prevent diabetes. Each respective response to the 3 questions were coded and scored according to whether they indicated engagement in the following activities: weight loss, physical activity, use of metformin, or enrollment into a diabetes prevention program. Each question denoted with a positive response were coded with 1 whereas those that did not were coded as a 0. The three questions were summed into a final score ranging from 0 (no report of engagement in the aforementioned healthy activities) with the worst outcome to 3 (a report of 3 of the 4 aforementioned healthy activities) with the best outcome. The final scores were generated based on the mean difference between baseline and 3-month scores.
Measured: 3 months
Participation in Weight-related Wellness Programs
The investigators will use survey data to evaluate how many participants enrolled in weight-related wellness programs from baseline to 3 months.
Measured: 3 months
Weight Loss Behaviors
The investigators will use survey data to evaluate changes in weight loss behaviors at the 3-month post intervention assessment.
Measured: 3 months
Physical Activity
The investigators will use survey data to evaluate changes in physical activity after the 3-month post intervention assessment. The International Physical Activity Questionnaire - Short Form (IPAQ-SF) was used to measure physical activity change. Respondents were asked to report how many hours and minutes within the past week they completed of vigorous physical activity, moderate physical activity, and brisk walking. The total sum of minutes for these three questions were subsequently coded into a yes/no binary variable for whether respondents met a recommended 150 minutes of overall physical activity within 7 days of being assessed. The values provided reflect a proportion of respondents that met or exceeded the 150 minute threshold of overall physical activity based on the newly generated variable that combined total minutes of vigorous physical activity, moderate physical activity, and brisk walking.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start1 Feb 2018
- Primary completion1 Mar 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The investigators will use a factorial design to test the main effects and a limited number of interaction effects of 5 messaging strategies.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jeffrey T. Kullgren, MD MPH MS, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403231
- Sponsor's protocol ID
- CDX 15-002
- Other IDs
- CDA 13-267
- Acronym
- INVENT
- Status last verified
- Jul 2023
- First submitted
- 10 Jan 2018
- Last updated
- 25 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INcreasing Veteran EngagemeNT to Prevent Diabetes (INVENT) (CDA 13-267)
- ClinicalTrials.gov ID
- NCT03403231
- Acronym / sponsor ID
- INVENT / CDX 15-002
- Conditions
- Prediabetes
- Keywords
- Veterans, Type 2 diabetes mellitus, Prediabetes, Secure Messaging, Health Promotion, Prevention and Control, Motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 18 Jan 2018 (actual)
- Results
- Posted 16 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate a VA MyHealtheVet Secure Messaging intervention that uses different intervention messaging strategies designed to increase engagement in behaviors to prevent type 2 diabetes.
The investigators will enroll 144 eligible Veterans into a 12-week MyHealtheVet Secure Messaging intervention. Eligible Veterans include those who are currently using MyHealtheVet secure messaging, meet inclusion/exclusion criteria, and have received an HbA1c test within the last 6 months that meets the ADA/CDC classification for prediabetes. Study participants will be surveyed about their engagement in behaviors to prevent TDM2 and mediators of this engagement. After completing a baseline survey, participants will be randomly assigned to receive different novel presentations of information about ways to prevent T2DM through both Secure Messaging and US Mail. The investigators will test the 5 presentations that each: (1) represent an innovative approach from behavioral economics or health psychology with great promise to increase engagement in behaviors to prevent T2DM among patients with prediabetes; and (2) have not been tested in this setting.
Detailed description
There is tremendous national enthusiasm for translating and disseminating efficacious strategies to prevent type 2 diabetes mellitus (T2DM). Yet, little attention has been devoted to how the investigators can better leverage the processes through which patients receive information about prevention of T2DM to better engage them in such prevention. Further, despite efforts to disseminate structured programs, many patients at high risk for developing T2DM may still be unable or unwilling to access them. In these cases, increasing patient engagement in individually directed lifestyle change or pharmacotherapy is critical. Strategies developed in the fields of behavioral economics and health psychology hold significant promise for improving Veteran engagement in each of these approaches. To date, however, these strategies have rarely been translated into real-world settings where they could benefit Veterans. This novel work will address this critical gap and could transform communication with Veterans about prevention in ways that will improve their health outcomes.
The following 5 strategies will be implemented in the weekly messages that study participants will receive: (1) tailoring to aspirations in life; (2) implementation intentions; (3) preference checklists; (4) urgency framing; (5) social norms. The investigators will implement these strategies alone and in combination in a 16-arm factorial design experiment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 16
- Model description
- The investigators will use a factorial design to test the main effects and a limited number of interaction effects of 5 messaging strategies.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Stock messages only | Active comparator | Behavioral: INVENT Secure Messaging InterventionParticipants will only receive the stock messages that encourage following recommended behaviors for reducing the risk for developing diabetes. |
| Arm 2: Urgency frame message strategy | Experimental | Behavioral: INVENT Secure Messaging InterventionParticipants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the urgency frame message strategy. |
| Arm 3: Social norm message strategy | Experimental | Behavioral: INVENT Secure Messaging InterventionParticipants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the social norm messaging strategy. |
| Arm 4: Urgency frame and social norm strategies | Experimental | Behavioral: INVENT Secure Messaging InterventionParticipants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the urgency frame and social norm messaging strategies. |
| Arm 5: Implementation Intentions and Urgency Frame | Experimental | Behavioral: INVENT Secure Messaging InterventionParticipants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the implementation intentions and urgency frame messaging strategies. |
| Arm 6: Implementation Intentions and Social Norm | Experimental | Behavioral: INVENT Secure Messaging InterventionParticipants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the implementation intentions and social norm messaging strategies. |
| Arm 7: Implementation Intentions, Urgency Frame & Social Norm | Experimental | Behavioral: INVENT Secure Messaging InterventionParticipants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the implementation intentions, urgency frame, and social norm messaging strategies. |
| Arm 8: Implementation Intentions | Experimental | Behavioral: INVENT Secure Messaging InterventionParticipants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the implementation intentions messaging strategy. |
| Arm 9: Preference Checklists and Urgency Frame | Experimental | Behavioral: INVENT Secure Messaging InterventionParticipants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the preference checklists and urgency frame messaging strategies. |
| Arm 10: Preference Checklists and Social Norms | Experimental | Behavioral: INVENT Secure Messaging InterventionParticipants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the preference checklists and social norm messaging strategies. |
| Arm 11: Preference Checklists, Urgency Frame & Social Norm | Experimental | Behavioral: INVENT Secure Messaging InterventionParticipants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the preference checklists, urgency frame, and social norm messaging strategies. |
| Arm 12: Preference Checklists | Experimental | Behavioral: INVENT Secure Messaging InterventionParticipants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the preference checklists messaging strategy. |
| Arm 13: Tailored Aspirations and Urgency Frame | Experimental | Behavioral: INVENT Secure Messaging InterventionParticipants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the tailored aspirations and urgency frame messaging strategies. |
| Arm 14: Tailored Aspirations and Social Norm | Experimental | Behavioral: INVENT Secure Messaging InterventionParticipants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the tailored aspirations and social norm messaging strategies. |
| Arm 15: Tailored Aspirations, Urgency Frame & Social Norm | Experimental | Behavioral: INVENT Secure Messaging InterventionParticipants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the tailored aspirations, urgency frame, and social norm messaging strategies. |
| Arm 16: Tailored Aspirations | Experimental | Behavioral: INVENT Secure Messaging InterventionParticipants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the tailored aspirations messaging strategy. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- HbA1c test within the past 6 months that meets the ADA/CDC requirements for prediabetes.
- Currently registered in the VA's MyHealtheVet Secure Messaging System
- Receiving care within the Ann Arbor VA Healthcare System
Key exclusion criteria (16 listed)
- Completed more than 4 VA MOVE! classes in the last year (or other evidence of another recent weight loss program)
- Are trying to lose weight and are very physically active
- Are >75 years of age
- Are pregnant or plan to be
- Are taking Metformin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INVENT Secure Messaging InterventionWe are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive. | Behavioural | Arm 10: Preference Checklists and Social Norms, Arm 11: Preference Checklists, Urgency Frame & Social Norm, Arm 12: Preference Checklists, Arm 13: Tailored Aspirations and Urgency Frame, Arm 14: Tailored Aspirations and Social Norm, Arm 15: Tailored Aspirations, Urgency Frame & Social Norm, Arm 16: Tailored Aspirations, Arm 1: Stock messages only, Arm 2: Urgency frame message strategy, Arm 3: Social norm message strategy, Arm 4: Urgency frame and social norm strategies, Arm 5: Implementation Intentions and Urgency Frame, Arm 6: Implementation Intentions and Social Norm, Arm 7: Implementation Intentions, Urgency Frame & Social Norm, Arm 8: Implementation Intentions, Arm 9: Preference Checklists and Urgency Frame |
Primary outcome
Engagement in Recommended Behaviors to Prevent Type 2 Diabetes
Time frame: 3 months
The investigators will use survey and medical record data to evaluate changes in participants' engagement in recommended behaviors to prevent type 2 diabetes.
8 secondary outcomes
Motivation to Prevent Type 2 Diabetes
Time frame: 3 months
Importance of Preventing Type 2 Diabetes
Time frame: 3 months
Use of Medication for T2DM Prevention
Time frame: 3 months
Perception for Risk for T2DM
Time frame: 3 months
Knowledge of Strategies to Prevent T2DM
Time frame: 3 months
Participation in Weight-related Wellness Programs
Time frame: 3 months
Weight Loss Behaviors
Time frame: 3 months
Physical Activity
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey T. Kullgren, MD MPH MS principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INVENT Secure Messaging Intervention in people with Prediabetes, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement in Recommended Behaviors to Prevent Type 2 Diabetes (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.