Patient SatisfactionRVRNCT06164145
Translation, Cross-cultural Adaptation, Reliability, Validity and Responsiveness of Short Form 36 (SF-36) Questionnaire in Stroke Survivors
An observational study of Patient Satisfaction, run by Khon Kaen University at 1 site in Burma.
Trial summary
The type of the study is an observational study to test in stroke survivors. The main questions it aims to answer are 1. What is a Burmese version, content validity, convergent validity, divergent validity, and reliability of SF-36 questionnaire in stroke survivors? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Satisfaction
- How many people
- 125 participants
- Where
- 1 siteBurma
- Study dates
- 30 Dec 2023to 30 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hemiplegic patients who will be treated at inpatient ward of Department of Physical Medicine and Rehabilitation
Who may be able to join
- Age 18 years and above (Coppers et al., 2021; Soto-Vidal et al., 2021; Wayessa et al., 2023)
- Hemiplegia induced by both ischemic and hemorrhagic stroke at least 1 month duration (Wayessa et al., 2023; Vincent-Onabajo, Owolabi \& Hamzat, 2014)
- Ability to understand the study and respond to questions (on the Mini- Mental State Examination > 23) (Wongchaisuwan et al., 2005; Muangpaisan et al., 2015)
- Stable medical conditions
Who cannot join
- Other neurological diseases such as Parkinson's disease, dementia, Alzheimer's disease, peripheral neuropathy according to medical history and record
- Recurrent stroke
- Participants with dysphasia, intellectual impairments, traumatic head injury, and psychiatric diseases (Wayessa et al., 2023)
- 3) Participants who cannot understand Burmese language
Trial locations and contacts
1 site in 1 country.
Burma1 site, 1 recruiting
- Recruiting
Yangon General Hospital
Yangon, 11131
Myitzu Khin Khin, Master, +959254219894, myitzu.k@kkumail.com
Sawitri Wanpen, PhD, +66951691352, sawitri@kku.ac.th
About this study
The type of the study is an observational study to test in stroke survivors. The main questions it aims to answer are
- What is a Burmese version, content validity, convergent validity, divergent validity, and reliability of SF-36 questionnaire in stroke survivors?
- Does the Burmese version of SF-36 have the responsiveness in stroke survivors? Participants will be interviewed the questionnaire by the research team.
Read the detailed description
Cross-cultural adaptation of a subjective questionnaire is required for use in a different country, culture, and/or language. Although the majority of questionnaires were created in English-speaking nations, researchers must nonetheless take into account non-native populations in health studies, particularly when their omission could result in a systematic bias in studies of health care usage (Beaton et al., 2000). For the purpose of translating and culturally adapting, it is crucial to achieve equality between the target and original sources of the questionnaire.
As it relates to the authors' perspective, the Short Form 36 (SF-36) has not yet been translated and cross-culturally adapted to be used in Myanmar. As a result, the features of a Burmese version's reliability and validity among individuals with a history of stroke have not been studied in the previous research work. In addition, the questionnaire should also be tested for its responsiveness to provide clinical meaningful for health care professions. Therefore, the aim of this study is to develop a Burmese version of the SF-36 (SF-36-Burmese) according to translation and cross-cultural adaption guidelines and evaluate its reliability, validity, and responsiveness (i.e., the instrument's capacity to identify changes over time in the construct being assessed) and the minimum clinical important difference (MCID, ie., the smallest change in an outcome that a patient would perceive as clinically meaningful) among stroke survivors.
- Conditions
- Patient Satisfaction
- Being tested
- Usual care
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careOther
The training program used in this study is the stroke rehabilitation program focusing on health education for stroke and a routine exercise program based on the National Strategic Plan for Stroke Rehabilitation in Myanmar.
| Study group | Role | What they receive |
|---|---|---|
| patients with hemiplegia | The intervention program will be based on usual care physiotherapy treatment in a hospital setting. It will be given 3 times per day, 5 days per week for 4 weeks duration. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form 36
Short Form 36 (SF-36) is a generic self-reported outcome measure that quantifies the quality of life in relation to health status. It is a 36-item valid and reliable evaluation with eight areas covering physical functioning, role limitations brought on by physical issues, bodily pain, general health perceptions, vitality, social functioning, role limitations brought on by emotional issues, and perceived mental health. The SF-36 also contains a single question called "health transition" that measures how respondents feel their over health status has changed over the course of a year. The scores range from 0-100 (the worst possible to the most possible) (Ware \& Sherbourne, 1992).
Measured: Baseline-1 week-4th week
Secondary outcomes (4)
Patient Reported Outcome Measurement System (PROMIS-29)
There are 7 categories of quality of life related to one's health in the PROMIS-29, a simplified form of PROMIS that assesses several factors (Appendix). It can be thought of as a "modern" modification of the SF-36 because it includes extra information regarding sleep disturbance that isn't directly examined in the SF-36 (Edelen et al., 2017). The seven PROMIS-29 domains include pain interference, physical function, weariness, anxiety, sleep disturbance, and satisfaction with social interaction (Deyo et al., 2016). The PROMIS-29 is made up of 29 questions. The 28 items have Likert scales ranging from 1 to 5, with the exception of the question measuring pain severity. Higher values imply a better quality of life in terms of pain interference, weariness, depression, anxiety, and sleep disruption, whereas lower values indicate better results for these factors (Deyo et al., 2016).
Measured: Baseline-1 week
Berg Balance Scale (BBS)
The BBS is a functional balance test with 14 test items are scored on a 5-point scale from 0 to 4, with 0 signifying the lowest point of function and 4 denoting the maximum degree of function. The range of the total score is 0 to 56.
Measured: Baseline-1 week
Barthel Index (BI)
The BI is a quick, reliable, and well-validated measure of dependence in mobility and Activities of Daily Living (ADL) i.e., feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing that gives a score range between 0 and 100.
Measured: Baseline-1 week
Global Rating of Change (GRC) Scale
The GRC scale will be utilized as an external criterion for the anchor-based approach. Based on the opinions of both the patients and their therapists, using a 15-point scale, this scale assesses the significant variations in the measured parameters of -7 (a great deal worse) to +7 (much better than baseline) (Jaeschke, 1988).
Measured: Baseline-1 week-4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start30 Dec 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- 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
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myitzu Khin, Khon Kaen University
- Investigators
- Myitzu Khin Khin, Master, Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164145
- Sponsor's protocol ID
- HE662138
- Acronym
- RVR
- Status last verified
- Mar 2024
- First submitted
- 1 Dec 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD and documents will be available for sharing 1 year after publication for a period of 2 years. Access to the IPD and documents will be open on the IPDShare website with registration.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation, Cross-cultural Adaptation, Reliability, Validity and Responsiveness of Short Form 36 (SF-36) Questionnaire in Stroke Survivors
- ClinicalTrials.gov ID
- NCT06164145
- Acronym / sponsor ID
- RVR / HE662138
- Conditions
- Patient Satisfaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 11 Dec 2023 (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.
The type of the study is an observational study to test in stroke survivors. The main questions it aims to answer are
- What is a Burmese version, content validity, convergent validity, divergent validity, and reliability of SF-36 questionnaire in stroke survivors?
- Does the Burmese version of SF-36 have the responsiveness in stroke survivors? Participants will be interviewed the questionnaire by the research team.
Detailed description
Cross-cultural adaptation of a subjective questionnaire is required for use in a different country, culture, and/or language. Although the majority of questionnaires were created in English-speaking nations, researchers must nonetheless take into account non-native populations in health studies, particularly when their omission could result in a systematic bias in studies of health care usage (Beaton et al., 2000). For the purpose of translating and culturally adapting, it is crucial to achieve equality between the target and original sources of the questionnaire.
As it relates to the authors' perspective, the Short Form 36 (SF-36) has not yet been translated and cross-culturally adapted to be used in Myanmar. As a result, the features of a Burmese version's reliability and validity among individuals with a history of stroke have not been studied in the previous research work. In addition, the questionnaire should also be tested for its responsiveness to provide clinical meaningful for health care professions. Therefore, the aim of this study is to develop a Burmese version of the SF-36 (SF-36-Burmese) according to translation and cross-cultural adaption guidelines and evaluate its reliability, validity, and responsiveness (i.e., the instrument's capacity to identify changes over time in the construct being assessed) and the minimum clinical important difference (MCID, ie., the smallest change in an outcome that a patient would perceive as clinically meaningful) among stroke survivors.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with hemiplegia | – | Other: Usual careThe intervention program will be based on usual care physiotherapy treatment in a hospital setting. It will be given 3 times per day, 5 days per week for 4 weeks duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemiplegic patients who will be treated at inpatient ward of Department of Physical Medicine and Rehabilitation
Key inclusion criteria (4 listed)
- Age 18 years and above (Coppers et al., 2021; Soto-Vidal et al., 2021; Wayessa et al., 2023)
- Hemiplegia induced by both ischemic and hemorrhagic stroke at least 1 month duration (Wayessa et al., 2023; Vincent-Onabajo, Owolabi \& Hamzat, 2014)
- Ability to understand the study and respond to questions (on the Mini- Mental State Examination > 23) (Wongchaisuwan et al., 2005; Muangpaisan et al., 2015)
- Stable medical conditions
Key exclusion criteria (4 listed)
- Other neurological diseases such as Parkinson's disease, dementia, Alzheimer's disease, peripheral neuropathy according to medical history and record
- Recurrent stroke
- Participants with dysphasia, intellectual impairments, traumatic head injury, and psychiatric diseases (Wayessa et al., 2023)
- 3) Participants who cannot understand Burmese language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual careThe training program used in this study is the stroke rehabilitation program focusing on health education for stroke and a routine exercise program based on the National Strategic Plan for Stroke Rehabilitation in Myanmar. | Other | patients with hemiplegia |
Primary outcome
Short Form 36
Time frame: Baseline-1 week-4th week
Short Form 36 (SF-36) is a generic self-reported outcome measure that quantifies the quality of life in relation to health status. It is a 36-item valid and reliable evaluation with eight areas covering physical functioning, role limitations brought on by physical issues, bodily pain, general health perceptions, vitality, social functioning, role limitations brought on by emotional issues, and perceived mental health. The SF-36 also contains a single question called "health transition" that measures how respondents feel their over health status has changed over the course of a year. The scores range from 0-100 (the worst possible to the most possible) (Ware \& Sherbourne, 1992).
4 secondary outcomes
Patient Reported Outcome Measurement System (PROMIS-29)
Time frame: Baseline-1 week
Berg Balance Scale (BBS)
Time frame: Baseline-1 week
Barthel Index (BI)
Time frame: Baseline-1 week
Global Rating of Change (GRC) Scale
Time frame: Baseline-1 week-4th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: Yes. IPD and documents will be available for sharing 1 year after publication for a period of 2 years. Access to the IPD and documents will be open on the IPDShare website with registration.
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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.
Myitzu Khin Khin, Master principal investigator
Khon Kaen 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 Patient Satisfaction, run by Khon Kaen University at 1 site in Burma.
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 4 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: status not confirmed, as of the sponsor's last update on 6 Mar 2024. 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 Burma. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Myitzu Khin Khin, Master (+959254219894, myitzu.k@kkumail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form 36 (time frame: Baseline-1 week-4th 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 6 Mar 2024.