Promoting Health by Self Experience (PHASE) Randomized Controlled Trial (PHASE)

June 2, 2010 updated by: Unilever Israel

Promoting Health by Self Experience (PHASE) randomized controlled trial

Study Hypothesis:

A personal experience in health promotion will affect the health prevention activities of the health providers and thus will impact their prevention activities toward their patients compared with a control (no-intervention) group.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Objective: To evaluate the effectiveness of a personal experience and personal initiation program on the health prevention activities of the health providers and the following impact on their patients compared with a control (no-intervention) group.

Methods: A randomized controlled trial Randomization: Health providers of all disciplines will be recruited from 10 clinics of Clalit Health Services, Dan district and randomized using cluster (by clinic) randomization, into an intervention and a control group. In each clinic 15 health care providers and 50 patients will be interviewed providing a total of 150 health care providers and 500 patients.

Intervention: The intervention will be delivered by psychologists and social workers trained in group facilitation and experimental learning. The program is based on theories of experimental learning and Bridges model of change. In each intervention clinic 5 workshops on the initiation of health prevention projects in each clinic will be organized by the intervention team and than the clinic will be followed by the intervention team for 6 months. No intervention will be provided to the control clinics.

Outcomes: changes in quality measurements of both intervention and non-intervention clinics. Among health providers changes in attitudes, personal views and life style as well as health prevention activities will be assessed by questionnaires. A random sample of 50 patients age 21-50 from each of the participating clinics will be selected and interviewed using a questionnaire. The questionnaires will include questions regarding the administration of screening tests, treatment of abnormal measurements, life style changes and satisfaction with the performance of the clinic and health care providers. The evaluation for both health care providers and patients will be performed at baseline and after 6 months.

Study Type

Interventional

Enrollment (Anticipated)

650

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petach Tikva, Israel
        • Recruiting
        • Clalit Health Services
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Health providers in selected clinics
  • Patients age 21-50 in selected clinics

Exclusion Criteria:

  • Patients age younger than 21 and older than 50
  • Health providers from clinics not in the area of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Health promotion
5 workshops on the initiation of health prevention projects in each clinic will be organized by the intervention team and than the clinic will be followed by the intervention team for 6 months.
Behavioral: Health promotion
In each intervention clinic 5 workshops on the initiation of health prevention projects in each clinic will be organized by the intervention team and than the clinic will be followed by the intervention team for 6 months.
No Intervention: Promoting Health
No intervention follow-up only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Promoting Health randomized controlled trial
Time Frame: 6 months
Changes in quality measurements Changes in attitudes, personal views and life style as well as health prevention activities
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unilever Israel

Investigators

  • Principal Investigator: Iris Shai, PhD, Ben-Gurion University of the Negev
  • Principal Investigator: Danit R Shahar, PhD, Ben-Gurion University of the Negev

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

January 1, 2011

Study Completion (Anticipated)

May 1, 2011

Study Registration Dates

First Submitted

May 22, 2010

First Submitted That Met QC Criteria

May 24, 2010

First Posted (Estimate)

May 25, 2010

Study Record Updates

Last Update Posted (Estimate)

June 3, 2010

Last Update Submitted That Met QC Criteria

June 2, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • unilever-0410-OL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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