Applicability of Cellular Application in Diabetes Type 2... | NCT02691273

Studies
Applicability of Cellular Application in Diabetes Type 2 Patients.

NCT02691273

Sponsor

Hadassah Medical Organization

Status

Completed

Last Update Posted

Nov 28, 2017Actual

Enrollment

9Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus, Type 2

Interventions

cellular application treating diabetes using breathing technique

Countries

Israel

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

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Mar 2017Actual

Completion Date

Jul 2017Actual

First Submitted Date

Jan 20, 2016

First Submission Date that Met QC Criteria

Feb 21, 2016

First Posted Date

Feb 25, 2016Estimated

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

Nov 26, 2017

Last Update Posted Date

Nov 28, 2017Actual

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

It was found that an important part of the factors impeding adherence to medication and a healthy lifestyle among the chronically ill diabetic patients lies in proper management of the disease. Since it is a chronic progressive disease the caregiver is the patient himself.Studies have shown that software system, sending text messages / messages / reminders daily and answering questionnaires can improve adherence to a change in lifestyle.

This study is an initial pilot study , which examines Feasibility ( Applicability ) of using a smart application that promotes a healthy lifestyle perseverance parallel use relaxation techniques .

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

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
breathing technique	Experimental	this arm includes learning breathing technique using the patient's smartphone.	Behavioral: cellular application treating diabetes using breathing technique

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cellular application treating diabetes using breathing technique	Behavioral		breathing technique

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
10 percentage improvement in the quality of life questionnaire		two months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HbA1c above 7.5.
Smartphone users.
English and Hebrew literate.

Exclusion Criteria:

*Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Avivit Cohen	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization		Jerusalem		9112-	Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided