Shalamar Institute of Health Sciences | NCT03800498

Studies
Shalamar Institute of Health Sciences

NCT03800498

Sponsor

Allama Iqbal Open University Islamabad

Status

Completed

Last Update Posted

Jan 14, 2019Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Effect of Didactic Intervention Regarding (DASH) on Hypertension

Interventions

DASH Education

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 10, 2018Actual

Primary Completion Date

Sep 10, 2018Actual

Completion Date

Oct 10, 2018Actual

First Submitted Date

Jan 9, 2019

First Submission Date that Met QC Criteria

Jan 9, 2019

First Posted Date

Jan 11, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2019

Last Update Posted Date

Jan 14, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Naiza Yousef, Student, Allama Iqbal Open University IslamabadPrincipal Investigator

Lead Sponsor

Allama Iqbal Open University IslamabadOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Effect of Didactic intervention regarding Dietary Approach to Stop Hypertension (DASH) on Hypertensive Patients Blood Pressure, Knowledge and Attitude at a Tertiary Hospital of Lahore

Detailed Description

Objective: To explore the effect of didactic intervention regarding dietary approach to stop hypertension (DASH) on hypertensive patients blood pressure, knowledge and attitude.

Study Design: Randomized controlled trial Place and Duration of Study: Punjab Institute of Cardiology (PIC) Lahore. From June 2018 to Oct 2018.

Methodology: Seventy volunteers aged 20-60 years attending regularly outpatient department at Punjab institute of cardiology Lahore, with systolic > 130 mm hg, diastolic > 80 mm hg were selected and assigned into 2 groups, i.e. Intervention and control, by simple random lottery method. For twelve weeks, only intervention group were given DASH education. Both groups were checked for DASH knowledge, attitude, and systolic diastolic blood pressure, before and after education session. Pre-tested questionnaire was used for demographic, attitude and knowledge data collection.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	For twelve weeks, only intervention group were given DASH education	Other: DASH Education
Controlled	No Intervention	Controlled group not received DASH education

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DASH Education	Other	DASH health education about general knowledge of DASH diet Plan and lifestyle modification	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pre-tested questionnaire was used	10 knowledge questions were asked with minimum score 0 and maximum 10. Attitude assessment consisted of 4 questions and score range was 0-4.	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hypertensive patient aged 20-60 years attending regularly at Punjab institute of cardiology outpatient department Lahore
systolic > 130 mm hg
diastolic > 80 mm hg.

Exclusion Criteria:

Less than 20 years age
patient diagnosed with secondary hypertension
any mental and physical ailment that may interfere the intervention like deafness and blindness.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zaheer Ahmad, PhD	Shalamar Institute of Health Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nazia		Lahore	Punjab Province	54000	Pakistan