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iNSPiRED for Diabetes (iNSPiRED Trial)

N/A

Waitlist Available

Led By Mark E. Kunik, MD MPH

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Veteran

Diagnosis of type 2 DM, per self-report

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and every 6 months assessed up to month 60

Awards & highlights

iNSPiRED Trial Summary

This trial is testing whether a coaching program can help Veterans with diabetes better manage their medical problems and stress.

Eligible Conditions

Diabetes

iNSPiRED Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

iNSPiRED Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and every 6 months assessed up to month 60

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and every 6 months assessed up to month 60

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and every 6 months assessed up to month 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Diabetes Distress Screening Scale (DDS17)

Secondary outcome measures

Change in Generalized Anxiety Disorder-7 Questionnaire (GAD-7)

Change in Patient Health Questionnaire-8 (PHQ-8)

Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)

+1 more

Other outcome measures

Change in PCORI Ways of Engaging-Engagement Activity Tool (WE-ENACT) Patient and Stakeholder Survey

Change in PCORI Ways of Engaging-Engagement Activity Tool (WE-ENACT) Researcher Survey

Change in Patient Activation Measure (PAM)

+2 more

iNSPiRED Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: iNSPiREDExperimental Treatment1 Intervention

Peer coaching intervention

Group II: Usual CareActive Control1 Intervention

Directory of resources and encouragement to follow-up with Primary Care Physician

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

iNSPiRED

2019

N/A

~220

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,385 Total Patients Enrolled

22 Trials studying Diabetes

13,392 Patients Enrolled for Diabetes

Mark E. Kunik, MD MPHPrincipal InvestigatorMichael E. DeBakey VA Medical Center, Houston, TX

3 Previous Clinical Trials

435 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being sought out for this experiment?

"Clinicaltrials.gov indicates that this medical study, initially made available on October 1st 2019 and edited most recently in November 15th 2022, is not currently recruiting subjects. However, there are still 1266 other clinical trials actively seeking enrollees at the present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Veteran Support and Resources for Diabetes

2019. "Veteran Support and Resources for Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04041375.