NCT04521257

Brief Summary

Quality of life (QOL) is an overarching term for the quality of the various domains in life. It is a standard level that consists of the expectations of an individual or society for a good life. These expectations are guided by the values, goals and socio-cultural context in which an individual lives. It is a subjective, multidimensional concept that defines a standard level for emotional, physical, material and social well-being. The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and an abbreviated variant of it, the SF-6D, is commonly used in health economics as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The original SF-36 stemmed from the Medical Outcome Study, MOS, which was conducted by the RAND Corporation. The primary objectives of this research were to translate, validate and generate normative data on the SF-36 health survey for using among Urdu speaking residents of Pakistan.SF-36 health questionnaire is first translated into Urdu and then apply on healthy subjects to check the validity and reliability of this scale . Instrument will be first translated from English to Urdu by two experts. Both these experts were fluent in English and Urdu language. One expert belongs to allied health care profession and other expert will be junior life scientist. The third expert compares the initial to Urdu translation and formulated the first draft of SF-36 Health Questionnaire. Content validity of SF-36 Health Questionnaire was established by committee method. 10 experts from physical therapy field rate the all 36 items of the SF-36 Health Questionnaire on content validity index developed by RAND Corporation. They rate each item of SF-36 Health Questionnaire for its relevance, clarity, simplicity, and ambiguity on four point ordinal likert scale. Data will be analyzed using SPSS v 25. Intra class correlation coefficient, chronbach alpha and factor analysis will be used to analyses the data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

July 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

10 months

First QC Date

August 18, 2020

Last Update Submit

August 23, 2021

Conditions

Keywords

Health Related Quality of LifePublic HealthHealth Status Indicators

Outcome Measures

Primary Outcomes (1)

  • Short Form 36

    The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. Pricing depends on the number of scores that the researcher needs to calculate.

    2nd Day

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy subjects aged between 20 to 60 years both male and female subjects will be included.Current health problems such as chronic allergy, back pain, visual impairments, chronic skin problems, chronic lung problems, deafness or hearing problems, functional impairment in leg or arm or other chronic health problems

You may qualify if:

  • Age between 20 to 60 years both male and female subjects

You may not qualify if:

  • Current health problems such as chronic allergy, back pain, visual impairments, chronic skin problems, chronic lung problems, deafness or hearing problems, functional impairment in leg or arm or other chronic health problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Riphah Rehabiliation Clinic

Lahore, Punjab Province, 54770, Pakistan

Location

Riphah International University

Lahore, 54000, Pakistan

Location

Related Publications (5)

  • Lins L, Carvalho FM. SF-36 total score as a single measure of health-related quality of life: Scoping review. SAGE Open Med. 2016 Oct 4;4:2050312116671725. doi: 10.1177/2050312116671725. eCollection 2016.

    PMID: 27757230BACKGROUND
  • Kolotkin RL, Andersen JR. A systematic review of reviews: exploring the relationship between obesity, weight loss and health-related quality of life. Clin Obes. 2017 Oct;7(5):273-289. doi: 10.1111/cob.12203. Epub 2017 Jul 10.

    PMID: 28695722BACKGROUND
  • Puciato D, Rozpara M, Borysiuk Z. Physical Activity as a Determinant of Quality of Life in Working-Age People in Wroclaw, Poland. Int J Environ Res Public Health. 2018 Mar 29;15(4):623. doi: 10.3390/ijerph15040623.

    PMID: 29596312BACKGROUND
  • Hasanvand S, Rassouli M, Mandegari Z, Salmani N, Moghimkhan F. A Critical Review of Instruments Measuring the Quality of Life of Cancer Patients in Iranian Studies and Their Psychometrics Properties. Asian Pac J Cancer Prev. 2019 Feb 26;20(2):333-343. doi: 10.31557/APJCP.2019.20.2.333.

    PMID: 30803191BACKGROUND
  • Lu WC, Tzeng NS, Kao YC, Yeh CB, Kuo TB, Chang CC, Chang HA. Correlation between health-related quality of life in the physical domain and heart rate variability in asymptomatic adults. Health Qual Life Outcomes. 2016 Oct 21;14(1):149. doi: 10.1186/s12955-016-0555-y.

    PMID: 27765048BACKGROUND

Study Officials

  • Danish Hassan, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 18, 2020

First Posted

August 20, 2020

Study Start

July 1, 2020

Primary Completion

May 1, 2021

Study Completion

June 1, 2021

Last Updated

August 27, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations