Feasibility of Use of BariCare App in Pre-transplant Popu... | NCT01859104

Studies
Feasibility of Use of BariCare App in Pre-transplant Population

NCT01859104

Sponsor

Mayo Clinic

Status

Withdrawn

Last Update Posted

Mar 22, 2018Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Obesity
Pre-Renal Transplant Candidate
Pre-liver Transplant Candidate

Interventions

Use of smartphone app

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

App to be used in study needs revision.

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Mar 2017Estimated

Completion Date

Mar 2017Estimated

First Submitted Date

May 17, 2013

First Submission Date that Met QC Criteria

May 17, 2013

First Posted Date

May 21, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2018

Last Update Posted Date

Mar 22, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This current study aims to evaluate the efficacy of engagement modules in assisting patients who are candidates for renal and liver transplantation make significant lifestyle modifications. With the help of the Center for Innovation (CFI), a smartphone app (Android and iOS compatible) has been created to assist in both educating and engaging patients to develop and maintain healthy lifestyle modifications. Our goal is to create a cost-effective, smartphone-based platform that serves to not only efficiently educate but to also verify competence and keep our patients engaged.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Smartphone Arm	Other	This is a feasibility trial and thus all participants in the study will be provided a smartphone app to assist them in making lifestyle modifications	Behavioral: Use of smartphone app

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Use of smartphone app	Behavioral		Smartphone Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Smart Phone App Feasibility	The primary objective will be to assess ease and feasibility of use by subjects. They will provide information through questionnaires developed to assess these factors.	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals who are candidates for liver or renal transplant.
Individuals who own a smartphone.
Individuals who are obese.

Exclusion Criteria:

Patients with prior history of bariatric surgery.
Patients with active psychiatric disorder.
Patients with active tobacco use.
Patients with active substance use (alcohol, illicit drugs, etc.)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Manpreet Mundi, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester		Rochester	Minnesota	55905	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided