NCT01859104

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2013

Completed
2.3 years until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

1.5 years

First QC Date

May 17, 2013

Last Update Submit

March 20, 2018

Conditions

ObesityPre-Renal Transplant CandidatePre-liver Transplant Candidate

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Use of smartphone appBEHAVIORAL
Smartphone Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Manpreet Mundi, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 17, 2013

First Posted

May 21, 2013

Study Start

September 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

March 22, 2018

Record last verified: 2018-03

Locations

US(1)