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Telehealth Training for Ostomy Patients

Q: How many sites are managing this experiment?

<p>University of <a href="https://www.withpower.com/clinical-trials/new-mexico">New mexico</a>, Sanford Research Center and University of <a href="https://www.withpower.com/clinical-trials/south-carolina">South carolina</a> Greenville (Prisma Health) are a few sites that offer this study. Additionally, there are 10 other locations where the trial is being conducted.</p>

N/A

Waitlist Available

Led By Robert Krouse, MD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

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

Must have

Participants must be able to complete the study questionnaires and sessions in English.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12months

Awards & highlights

Study Summary

This trial is studying a web-based self-management program for rural ostomy patients.

Who is the study for?

This trial is for adult cancer survivors who've had surgery requiring an ostomy, living in non-urban areas. They must be at least six weeks post-operation, able to complete English questionnaires and training sessions, and consent to the study. A caregiver's support is encouraged but not mandatory.Check my eligibility

What is being tested?

The trial tests Ostomy Self-Management Training via telehealth aimed at improving quality of life for rural ostomy patients. It seeks to provide a solution where in-person training isn't feasible due to distance or other barriers.See study design

What are the potential side effects?

Since this intervention involves educational training rather than medication or invasive procedures, traditional physical side effects are not expected. However, participants may experience varying levels of emotional discomfort or stress during adaptation.

Eligibility Criteria

Inclusion Criteria

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

Select...

I can complete questionnaires and sessions in English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Patient Activation - PAM

Patient Activation- PAM

Secondary outcome measures

Health-related quality of life

Healthcare utilization long form

Healthcare utilization short form

+2 more

Other outcome measures

Anxiety

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Ostomy Self-Management TrainingActive Control1 Intervention

Ostomy Self-management Training group in which subject will learn using pouches and equipment, skincare, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for traveling and physical activity recommendations

Group II: Usual carePlacebo Group1 Intervention

Usual care in peri-operative and long-term settings is not standardized for ostomy patients. Usual care does not provide any formal, reproducible training for patients or their caregivers. It typically consists of an Ostomy Care Nurse who works with patients and caregivers concerning technical issues (fitting, emptying, supplies, surrounding skin care, etc.) while the new ostomate is still an inpatient.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,687 Previous Clinical Trials

40,930,167 Total Patients Enrolled

University of PennsylvaniaLead Sponsor

2,009 Previous Clinical Trials

42,894,449 Total Patients Enrolled

Robert Krouse, MDPrincipal InvestigatorUniversity of Pennsylvania

1 Previous Clinical Trials

216 Total Patients Enrolled

Media Library

Ostomy Self-Management Training Clinical Trial Eligibility Overview. Trial Name: NCT03913715 — N/A

Ostomy Research Study Groups: Ostomy Self-Management Training, Usual care

Ostomy Clinical Trial 2023: Ostomy Self-Management Training Highlights & Side Effects. Trial Name: NCT03913715 — N/A

Ostomy Self-Management Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT03913715 — N/A

Frequently Asked Questions

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

How many sites are managing this experiment?

"University of New mexico, Sanford Research Center and University of South carolina Greenville (Prisma Health) are a few sites that offer this study. Additionally, there are 10 other locations where the trial is being conducted."

Answered by AI

Are individuals aged 55 or older being accepted into this experiment?

"This clinical trial is restricted to individuals aged 18-120. There are 43 trials for minors and 220 trials available for senior citizens."

Answered by AI

Are there currently any vacancies for participants in this experiment?

"Affirmative. According to clinicaltrials.gov, this experiment has been open for patient recruitment since the 1st of August 2019 and was most recently updated on 6th September 2022. It is aiming to enrol 208 participants from 10 research sites across the country."

Answered by AI

What is the scope of individuals participating in this clinical trial?

"This trial necessitates 208 subjects that meet the predetermined qualifications. Those interested can sign-up at University of New mexico (Albuquerque, NM) or Sanford Research Center (Fargo, ND)."

Answered by AI

What are the primary aims of this medical experiment?

"This clinical trial will last for 12 months and measure the primary outcome of Patient Activation - PAM. Secondary outcomes that also need to be evaluated are Self-efficacy (which covers 8 domains) as well Healthcare utilization both in long form and short form alike."

Answered by AI

Am I eligible to partake in this experiment?

"This clinical study is recruiting 208 adults aged between 18 and 120 who have undergone ostomy surgery. Crucial eligibility criteria include: the participant's ability to understand the protocol, sign an informed consent form, complete questionnaires & sessions in English; willingness to take part in surveys & training 6 weeks after their operation; no maximum time since surgery; residence within a non-metropolitan or non-urban zip code as well as participating in/during corresponding trainings (intervention/usual care arm)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ostomy Rural Telehealth Training Cancer Survivors

2019. "Ostomy Rural Telehealth Training Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03913715.

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