Promoting Health by Self Experience (PHASE) Randomized Controlled Trial

Health Prevention Activities Clinical Trial

— PHASE  

Official title:

Promoting Health by Self Experience (PHASE) Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01129895
• Other study ID #: unilever-0410-OL
• Status: Recruiting
• Phase: N/A
• First received: May 22, 2010
• Last updated: June 2, 2010
• Start date: April 2010
• Est. completion date: May 2011

Study information

• Verified date: June 2010
• Source: Unilever Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unilever: IsraelProlog initiation company: Israel
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: May 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Health Prevention Activities
• Impact on Patients
• Personal Experience and Personal Initiation Program

Intervention

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.

Locations

Country	Name	City	State
Israel	Clalit Health Services	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Unilever Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Promoting Health randomized controlled trial	Changes in quality measurements Changes in attitudes, personal views and life style as well as health prevention activities	6 months	No