Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-28 @ 2:19 AM
Study NCT ID:
NCT01129895
Status:
UNKNOWN
Last Update Posted:
2010-06-03
First Post:
2010-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promoting Health by Self Experience (PHASE) Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006293', 'term': 'Health Promotion'}], 'ancestors': [{'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 650}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2011-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-06-02', 'studyFirstSubmitDate': '2010-05-22', 'studyFirstSubmitQcDate': '2010-05-24', 'lastUpdatePostDateStruct': {'date': '2010-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Promoting Health randomized controlled trial', 'timeFrame': '6 months', 'description': 'Changes in quality measurements Changes in attitudes, personal views and life style as well as health prevention activities'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Personal Experience and Personal Initiation Program', 'Health Prevention Activities', 'Impact on Patients']}, 'referencesModule': {'references': [{'pmid': '22906808', 'type': 'DERIVED', 'citation': 'Shai I, Erlich D, Cohen AD, Urbach M, Yosef N, Levy O, Shahar DR. The effect of personal lifestyle intervention among health care providers on their patients and clinics; the Promoting Health by Self Experience (PHASE) randomized controlled intervention trial. Prev Med. 2012 Oct;55(4):285-291. doi: 10.1016/j.ypmed.2012.08.001. Epub 2012 Aug 12.'}]}, 'descriptionModule': {'briefSummary': 'Promoting Health by Self Experience (PHASE) randomized controlled trial\n\nStudy Hypothesis:\n\nA 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.', 'detailedDescription': '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.\n\nMethods: 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.\n\nIntervention: 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.\n\nOutcomes: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Health providers in selected clinics\n* Patients age 21-50 in selected clinics\n\nExclusion Criteria:\n\n* Patients age younger than 21 and older than 50\n* Health providers from clinics not in the area of the study'}, 'identificationModule': {'nctId': 'NCT01129895', 'acronym': 'PHASE', 'briefTitle': 'Promoting Health by Self Experience (PHASE) Randomized Controlled Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Unilever Israel'}, 'officialTitle': 'Promoting Health by Self Experience (PHASE) Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'unilever-0410-OL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Health promotion', 'description': '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.', 'interventionNames': ['Behavioral: Health promotion']}, {'type': 'NO_INTERVENTION', 'label': 'Promoting Health', 'description': 'No intervention follow-up only'}], 'interventions': [{'name': 'Health promotion', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Health promotion']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Petah Tikva', 'state': 'Israel', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Dorit Erlich, MD', 'role': 'CONTACT', 'email': 'dorite@clalit.org.il', 'phone': '972507348786'}], 'facility': 'Clalit Health Services', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'overallOfficials': [{'name': 'Iris Shai, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ben-Gurion University of the Negev'}, {'name': 'Danit R Shahar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ben-Gurion University of the Negev'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unilever Israel', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Danit R Shahar', 'oldOrganization': 'Ben-Gurion University'}}}}