COPDNCT04879095
Urdu Translation, Validity and Reliability of Dyspnea 12 (D-12)
An observational study of COPD, run by Riphah International University at 1 site in Pakistan.
Trial summary
Dyspnea is a distressing symptom with pain like perception. The object of study is to translate a tool that measure overall dyspnea severity. Although many scales are available to assess dyspnea but D12 is a clear reliable scale and is use full in clinical practice to assess dyspnea in terms of intensity, quality and… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Aug 2020to 24 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: COPD
Who may be able to join
- Patient age between 40-65 with diagnosis of COPD
- Outpatient individual who are on follow up
- Healthy individual
- Those who can read and understand English and Urdu as well.
Who cannot join
- Patient with cognitive impairment or sensory disorder were exclude.
- Patient physical disability
- Refuse to perform test
Trial locations and contacts
1 site in 1 country.
About this study
Dyspnea is a distressing symptom with pain like perception. The object of study is to translate a tool that measure overall dyspnea severity. Although many scales are available to assess dyspnea but D12 is a clear reliable scale and is use full in clinical practice to assess dyspnea in terms of intensity, quality and emotional response.
Read the detailed description
Aim of study is to translate a clinical validate of Urdu version of D-12 in COPDs patients. The study will measure reliability \& validity of dyspnea in Urdu version. No study has been conducted in our region to translate D-12 follow the proper cross culture adaptation. Therefor the instrument will translate in our language adapting proper cross culture guidelines.
- Conditions
- COPD
- Keywords
- Body mass index (BMI), Rate of perceived exertion (RPE), 6 minute walk test (^MWT)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Translation of Dyspnea 12 in Urdu version
D12 scale is used in assessment of dyspnea severity using its descriptors consist of sensory quality and effective component. It's a 12 item scale from 1-7 item related to physical component score (quality of sensation of dyspnea) \& from 8-12 related to emotional response of this sensation. Each item was graded on 4 point scale as none, mild, moderate \& severe and scored as 0 to 3 to get final score of 0 to 36
- Forward conversion
- Professional panel
- Backward conversion
- Pretesting
- Final Form The translation of Dyspnea12 (D-12) Questionnaire into Urdu was done by using Cross Cultural Adaptation techniques according to WHO guideline it involve the following steps
- Forward conversion
- Professional panel
- Backward conversion
- Pretesting
- Final Form
Measured: 4 Week
Secondary outcomes (2)
Six minute Walk test
It is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as outcome by which to compare changes in performance capacity. 30-metre stretch of unimpeded walkway is used and patient is instructed to walk as far as possible for 6 minutes. Test retest reliability of 6MWT showed good internal consistency (ICC=0.9) in patients with heart failure patients
Measured: 4 week
Rate Perceived Exertion
The scale is used to monitor and guide exercise intensity and help in measure how hard your body is working when you exercise. It gives estimate of your heart rate and exercise intensity zone. The scale ranges from 6 -20. 6 indicate no exertion and 20 denotes maximum exertion, it is simple numerical list.
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start13 Aug 2020
- Primary completion24 Apr 2021
- Study completion24 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sumaiyah Obaid, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879095
- Sponsor's protocol ID
- REC00780 Mehwish Shabbir
- Status last verified
- Jun 2021
- First submitted
- 4 May 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urdu Translation, Validity and Reliability of Dyspnea 12 (D-12)
- ClinicalTrials.gov ID
- NCT04879095
- Acronym / sponsor ID
- REC00780 Mehwish Shabbir
- Conditions
- COPD
- Keywords
- Body mass index (BMI), Rate of perceived exertion (RPE), 6 minute walk test (^MWT)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 24 Apr 2021 (actual)
- Study completion
- 24 Apr 2021 (actual)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dyspnea is a distressing symptom with pain like perception. The object of study is to translate a tool that measure overall dyspnea severity. Although many scales are available to assess dyspnea but D12 is a clear reliable scale and is use full in clinical practice to assess dyspnea in terms of intensity, quality and emotional response.
Detailed description
Aim of study is to translate a clinical validate of Urdu version of D-12 in COPDs patients. The study will measure reliability \& validity of dyspnea in Urdu version. No study has been conducted in our region to translate D-12 follow the proper cross culture adaptation. Therefor the instrument will translate in our language adapting proper cross culture guidelines.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- COPD
Key inclusion criteria (4 listed)
- Patient age between 40-65 with diagnosis of COPD
- Outpatient individual who are on follow up
- Healthy individual
- Those who can read and understand English and Urdu as well.
Key exclusion criteria (3 listed)
- Patient with cognitive impairment or sensory disorder were exclude.
- Patient physical disability
- Refuse to perform test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Translation of Dyspnea 12 in Urdu version
Time frame: 4 Week
D12 scale is used in assessment of dyspnea severity using its descriptors consist of sensory quality and effective component. It's a 12 item scale from 1-7 item related to physical component score (quality of sensation of dyspnea) \& from 8-12 related to emotional response of this sensation. Each item was graded on 4 point scale as none, mild, moderate \& severe and scored as 0 to 3 to get final score of 0 to 36 * Forward conversion * Professional panel * Backward conversion * Pretesting * Final Form The translation of Dyspnea12 (D-12) Questionnaire into Urdu was done by using Cross Cultural Adaptation techniques according to WHO guideline it involve the following steps * Forward conversion * Professional panel * Backward conversion * Pretesting * Final Form
2 secondary outcomes
Six minute Walk test
Time frame: 4 week
Rate Perceived Exertion
Time frame: 4 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sumaiyah Obaid, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Translation of Dyspnea 12 in Urdu version (time frame: 4 Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021.