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Decision Support Tool for Peripheral Arterial Disease
N/A
Recruiting
Led By Kim G Smolderen, PhD
Research Sponsored by Saint Luke's Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
New onset complaints of PAD symptoms or exacerbation of previous PAD symptoms
Age ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial aims to improve care for patients with PAD by making evidence on treatment outcomes more transparently available to patients and providers, such that more informed, evidence-based shared treatment decisions occur.
Who is the study for?
The SHOWME-PAD trial is for English-speaking men and women over 18 with Peripheral Arterial Disease (PAD), diagnosed through tests like Doppler ABI, Duplex, CTA, MRA, TCOM or Angiogram. It's not for those who can't consent, don't speak English, have had certain leg procedures in the past year or are currently experiencing severe PAD symptoms.Check my eligibility
What is being tested?
This trial is testing a Decision Support Tool designed to help patients with PAD and their providers make better-informed treatment decisions by providing clear information on health outcomes from the patient's perspective.See study design
What are the potential side effects?
Since this trial involves a decision support tool rather than medication or invasive treatments, traditional physical side effects are not expected. However, there may be psychological impacts from learning about disease outcomes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have new or worsening symptoms of leg pain when walking.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Decisional Conflict
Trial Design
1Treatment groups
Experimental Treatment
Group I: Received Decision ToolExperimental Treatment1 Intervention
Peripheral artery disease patients that received the decision support tool.
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Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,055,011 Total Patients Enrolled
8 Trials studying Peripheral Arterial Disease
52,612 Patients Enrolled for Peripheral Arterial Disease
Saint Luke's Health SystemLead Sponsor
41 Previous Clinical Trials
12,874 Total Patients Enrolled
2 Trials studying Peripheral Arterial Disease
1,613 Patients Enrolled for Peripheral Arterial Disease
Kim G Smolderen, PhDPrincipal InvestigatorUniversity of Missouri Kansas City; Saint Luke's Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your ankle-brachial index is higher than 1.30 and cannot be compressed.I had surgery to improve blood flow in the same leg that's currently symptomatic.I am experiencing severe leg pain, ulcers, or gangrene due to poor blood flow.I am unable to understand or sign the consent form.I do not speak English.I speak English and belong to any race or ethnicity.I have new or worsening symptoms of leg pain when walking.People who are in jail or prison.You have dementia.I have a confirmed diagnosis of poor blood flow in my legs.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Received Decision Tool
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are engaged in this clinical experiment?
"Affirmative. According to clinicaltrials.gov, this medical trial is actively recruiting patients and was initially posted on June 24th 2017, with the most recent update occurring in April 7th 2022. A total of 72 participants are being sought from one location."
Answered by AI
Are there any unfilled opportunities for participants in this experiment?
"As visible on clinicaltrials.gov, the medical trial is presently recruiting patients and was originally posted on June 24th 2017 before being updated lastly on April 7th 2022."
Answered by AI
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