NCT02512328

Brief Summary

Feasibility of an newly programmed offline application for smartphones (SPA, APP) for colonoscopy preparation offering a 5 day guidance prior colonoscopy containing dietary- and behavioral recommendation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

February 24, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

July 30, 2015

Status Verified

July 1, 2015

Enrollment Period

7 months

First QC Date

February 24, 2015

Last Update Submit

July 27, 2015

Conditions

Gastrointestinal Neoplasms

Keywords

Colonoscopynew mediaAPPcolonoscopy preparationSPAsmartphone application

Outcome Measures

Primary Outcomes (1)

  • Feasibility

    feasibility of app supported colonoscopy preparation (stable working and function of software on smartphone)

    at day 0 colonoscopy after colonoscopy preparation

Secondary Outcomes (2)

  • Bowel preparation

    at day 0 after colonoscopy

  • patient´s satification

    day 1 after colonoscopy

Study Arms (2)

Regular colonoscopy preparation

NO INTERVENTION

Comparison group. Regular colonoscopy preparation

APP supported colonoscopy preparation

EXPERIMENTAL

APP as additional device for colonoscopy preparation

Device: APP supported colonoscopy preparation

Interventions

APP supported colonoscopy preparationDEVICE

additional usage of an app for colonoscopy preparation

APP supported colonoscopy preparation

Eligibility Criteria

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

You may qualify if:

  • outpatient colonoscopy
  • smartphone owner with android system

You may not qualify if:

  • chronic renal failure
  • anticoagulants
  • pregnancy
  • diabetes mellitus (IDDM)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Medical Department, Klinikum rechts der Isar

Munich, 81675, Germany

RECRUITING

Related Publications (1)

  • Walter B, Schmid R, von Delius S. A Smartphone App for Improvement of Colonoscopy Preparation (ColoprAPP): Development and Feasibility Study. JMIR Mhealth Uhealth. 2017 Sep 20;5(9):e138. doi: 10.2196/mhealth.7703.

    PMID: 28931498DERIVED

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Benjamin M Walter, MD

    Physician

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin M Walter, MD

CONTACT

0049-89-4140-2251Benjamin.Walter@lrz.tum.de

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

February 24, 2015

First Posted

July 30, 2015

Study Start

March 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

July 30, 2015

Record last verified: 2015-07

Locations

DE(1)