NCT02074540

Brief Summary

To determine the predicting factors and indicators of compliance with insulin treatment in Diabetes Type II patients.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

Shorter than P25 for all trials

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 26, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 28, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 28, 2014

Status Verified

February 1, 2014

Enrollment Period

4 months

First QC Date

February 26, 2014

Last Update Submit

February 26, 2014

Conditions

Diabetes Type II

Outcome Measures

Primary Outcomes (1)

  • Insulin adherence

    Average number of positive responses on the questionnaire scale

    Forty minutes

Study Arms (1)

Diabetes Type II Patients

Other: Questionnaire

Interventions

QuestionnaireOTHER

Questionnaire that is based on socio-demographic characteristics, Morisky's Four-Item Self-Reported Adherence Measure, Becker's Theory of Health Beliefs and Mishel's Theory of Uncertainty

Diabetes Type II Patients

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Diabetes Type II patients who receive insulin and are hospitalized in the Hillel Yaffe Medical Center in a variety of departments. Patients are both Hebrew and Arabic speaking.

You may qualify if:

  • With complete cognitive abilities
  • Independent functioning
  • Take insulin

You may not qualify if:

  • Critically ill patients
  • Psychiatric patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jalal Ashkar, MD

    Hillel Yaffe Medical Center

    STUDY DIRECTOR

  • Rinat Majadly, RN, BA

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rinat Majadly, RN, BA

CONTACT

972-50-9366280noona.412@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2014

First Posted

February 28, 2014

Study Start

April 1, 2014

Primary Completion

August 1, 2014

Study Completion

December 1, 2014

Last Updated

February 28, 2014

Record last verified: 2014-02