NCT03148041

Brief Summary

The investigator of this study would like to test the hypothesis of the effectiveness of health education program on level of awareness of stroke among population at risk whom attending the primary health care center in Jeddah, in Saudi Arabia. The investigator will divide the participants into two groups. The intervention group whom will have the intensive health education program, and the control group whom will have the routine care. Participants will be followed up for 3 months to assess the effect of different health education programs on their level of awareness about stroke. Also The investigator will relate different socioeconomic factors to level of awareness.

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
90

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable stroke

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 10, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2018

Completed
Last Updated

October 19, 2017

Status Verified

October 1, 2017

Enrollment Period

2 months

First QC Date

May 5, 2017

Last Update Submit

October 17, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Calculate the score level of awareness of stroke symptoms

    Accurate response rates of stroke symptoms that included in the questionnaire. It will be scored out of 9.

    The outcome 1 will be assessed at baseline, 6 weeks, and 12 week of study.

Secondary Outcomes (1)

  • Calculate the percentage of the socioeconomics factors that identified by the participants as risk factors for stroke.

    The outcome 2 will be assessed at baseline, 6 weeks, and 12 week of study.

Study Arms (2)

intensive health education program

ACTIVE COMPARATOR

Participants in the intervention group will have an intensive health education program of the introductory lecture and brochures about stroke as well as they fill up the questionnaire at baseline. At week 6 and 12 of the study the participants will only fill up the questionnaire.

Other: health education program

routine care

PLACEBO COMPARATOR

Participants in the control group will have a routine care of different lecture and brochures than the intervention group as well as they fill up the questionnaire at baseline. At week 6 and 12 of the study the participants will only fill up the questionnaire.

Other: health education program

Interventions

Intensive health education program for intervention group: 1.The introductory 30 minute Arabic lecture for increase level of the awareness of the participants regarding stroke. Lecture from the USA National Stroke Association, 2011, will be used. The lecture includes the following issues about stroke (1) definition; (2) signs and symptoms; (3) risk factors; (4) treatment; and (5) prevention. 2\. Self-help materials will involve health education brochures regarding stroke and will be distributed for all participants at the time they are attending the lecture. The brochures which will be used for this study will be collected from the World Stroke Day 2016 Brochures, the Arabic version. The routine care for control group: different lecture and brochures will be used

intensive health education programroutine care

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The eligibility criteria for the participants included in this study involved both male and female of 40 year old or more of different body weights, and able to speak Arabic. Participants with at least one risk factor like hypertensive, diabetic, and dyslipidemia will be included in this study.

You may not qualify if:

  • A family member of any participants will be excluded and will not participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • farah A mansuri, professor

    Taibah University

    STUDY CHAIR

Central Study Contacts

farah A mansuri, professor

CONTACT

ibrahim R noor elahi, doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator Dr Ibrahim Rashad Noor Elahi, MD, MPH

Study Record Dates

First Submitted

May 5, 2017

First Posted

May 10, 2017

Study Start

November 1, 2017

Primary Completion

December 30, 2017

Study Completion

March 2, 2018

Last Updated

October 19, 2017

Record last verified: 2017-10