NCT04739163

Brief Summary

To translate, culturally adapt, and validate the Duke Activity Status Index (DASI) to the Pakistani Urdu language. The study will measure the reliability \& validity of DASI in the Urdu version.No study has been conducted in the Pakistan region to translate DASI which follows the proper cross-culture adaptation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

May 20, 2021

Status Verified

May 1, 2021

Enrollment Period

5 months

First QC Date

February 2, 2021

Last Update Submit

May 19, 2021

Conditions

Keywords

Duke activity status indexHeart DiseasesTool Translation

Outcome Measures

Primary Outcomes (1)

  • Translation of Duke Activity Status Index (DASI) in Urdu

    The Duke Activity Status Index Scale (DASI) is a questionnaire, originally developed in English to assess the functional capacity. DASI has been used mainly to evaluate patients with cardiovascular diseases, such as coronary artery disease, heart failure, myocardial ischemia and infarction.

    6 months

Secondary Outcomes (1)

  • validity & reliability of Duke Activity Status Index Scale (DASI) in Urdu version

    6 months

Eligibility Criteria

Age22 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

To meet inclusion criteria participants will be diagnosed with heart disease, clinically stable, and able to read the Urdu version of DASI. Then patient response will be checked on the translated Urdu version.

You may qualify if:

  • Individuals have enough education level to understand Urdu and English as well with a body mass index between 18.6 and 39.9 kg/m with the diagnosis of cardiovascular diseases such as coronary artery disease, valvular heart disease, arrhythmia with at least one symptom11 such as chest pain, palpitations, fatigue, or dyspnea, and physician referral to exercise testing.

You may not qualify if:

  • Individual is unable to read the questionnaire, who have cognitive deficits screened by Mini-Mental State Examination according to the cut-off points and Hospitalization two months before as well as acute illness, fever, or severe physical limitation that would prevent from doing the exercise test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AllamaIqbal hospital

Sialkot, Punjab Province, 51040, Pakistan

Location

Related Publications (4)

  • Chung SC, Hlatky MA, Stone RA, Rana JS, Escobedo J, Rogers WJ, Bromberger JT, Kelsey SF, Brooks MM. Body mass index and health status in the Bypass Angioplasty Revascularization Investigation 2 Diabetes Trial (BARI 2D). Am Heart J. 2011 Jul;162(1):184-92.e3. doi: 10.1016/j.ahj.2011.03.019.

    PMID: 21742107BACKGROUND
  • Scotto CJ, Waechter DJ, Rosneck J. Adherence to prescribed exercise and diet regimens two months post-cardiac rehabilitation. Can J Cardiovasc Nurs. 2011;21(4):11-7.

    PMID: 22165501BACKGROUND
  • George MJ, Kasbekar SA, Bhagawati D, Hall M, Buscombe JR. The value of the Duke Activity Status Index (DASI) in predicting ischaemia in myocardial perfusion scintigraphy - a prospective study. Nucl Med Rev Cent East Eur. 2010;13(2):59-63.

    PMID: 21598228BACKGROUND
  • Coutinho-Myrrha MA, Dias RC, Fernandes AA, Araujo CG, Hlatky MA, Pereira DG, Britto RR. Duke Activity Status Index for cardiovascular diseases: validation of the Portuguese translation. Arq Bras Cardiol. 2014 Apr;102(4):383-90. doi: 10.5935/abc.20140031. Epub 2014 Feb 17.

    PMID: 24652056BACKGROUND

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Mehwish Waseem, MSPT(CPPT)

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2021

First Posted

February 4, 2021

Study Start

October 1, 2020

Primary Completion

March 1, 2021

Study Completion

April 1, 2021

Last Updated

May 20, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations