NCT02691273

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 .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 25, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

November 28, 2017

Status Verified

August 1, 2017

Enrollment Period

2 years

First QC Date

January 20, 2016

Last Update Submit

November 26, 2017

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • 10 percentage improvement in the quality of life questionnaire

    two months

Study Arms (1)

breathing technique

EXPERIMENTAL

this arm includes learning breathing technique using the patient's smartphone.

Behavioral: cellular application treating diabetes using breathing technique

Interventions

cellular application treating diabetes using breathing techniqueBEHAVIORAL
breathing technique

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \*Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 9112-, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Avivit Cohen

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2016

First Posted

February 25, 2016

Study Start

March 1, 2015

Primary Completion

March 1, 2017

Study Completion

July 1, 2017

Last Updated

November 28, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)