StrokeNCT03729648
Expressive Arts-based Intervention for Young and Pre-elderly Stroke Survivors
A study testing Expressive Arts Therapy in people with Stroke, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Stroke is a devastating illness that induces numerous impairments of body function and structure, and limitations to activities in all aspects of life, thus imposing multi-faceted restrictions on one's participation in daily living. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Stroke
- What is being tested?
- Expressive Arts Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2018to 31 Dec 2022
- Phase
- Interventional
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of a single-lesion stroke in the left or right, temporal, frontal, parietal or subcortical brain region
- Experienced a major stroke event within 120 months from the time of study participation
- Diagnosis of either (a) ischemic or (b) hemorrhagic stroke
- Disability grade 1 to 4 on the Modified Rankin Scale
- With residual functions of the affected extremity
- The ability to understand instructions, both verbal and written in Chinese, and;
- Ages 18 to below 65
Who cannot join
- Concurrent diagnosis of major medical or psychiatric disorders other than stroke (except depression)
- Currently receiving hospital treatment and care
- Presence of hearing or visual deficits, even with aids
- Total paralysis of the upper limbs
- Amputation of one of the limbs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Psycho-physiological & Social-spiritual Effects of Expressive Arts-based Intervention on Young and Pre-elderly Stroke Survivors: A Randomized Controlled Study
Stroke is a devastating illness that induces numerous impairments of body function and structure, and limitations to activities in all aspects of life, thus imposing multi-faceted restrictions on one's participation in daily living. It also has detrimental impacts on one's mental health, social relationship, and quality of life. Existing research focuses primarily on older adults stroke survivors; this study is set out to contribute to current knowledge of the effectiveness of arts-based rehabilitation on younger stroke survivors. Both psychological and physiological outcomes will be examined for a comprehensive understanding on the biological, psychological, social, and spiritual changes after participating in a non-pharmacological, engaging, safe and enjoyable multi-modal expressive arts-based intervention approach of rehabilitation.This current study will adopt a 2-arm randomized controlled design with treatment-as-usual control. Upon screening for inclusion exclusion criteria, baseline data will be collected; and eligible participants will be randomized into either an 8-week Expressive Arts-based intervention group or Treatment-As-Usual control group.
Read the detailed description
Stroke is a devastating illness that induces numerous impairments of body function and structure, and limitations to activities in all aspects of life, thus imposing multi-faceted restrictions on one's participation in daily living. It also has detrimental impacts on one's mental health, social relationship, and quality of life. Stroke survivors often face challenges arising from the illness and its disabilities, as well as the resulting deterioration of occupational functioning. They also suffer from the psycho-spiritual sequels of loss in functioning, sense of worthlessness and hopelessness, and fear of relapse, all of which could result in mental health distress such as depression, anxiety, stress, isolation, and impaired quality of life. Though the risk of stroke increases with age, statistics have documented an increasing trend of a younger age of onset. The issues faced by younger and pre-elderly stroke survivors (<65 years old) will be even more severe due to longer term of survival, problems of resuming their occupations, and lacking of social welfare and resources for their pre-elderly age.
Existing research focuses primarily on older adults stroke survivors; this study is set out to contribute to current knowledge of the effectiveness of arts-based rehabilitation on younger stroke survivors. Both psychological and physiological outcomes will be examined for a comprehensive understanding on the biological, psychological, social, and spiritual changes after participating in a non-pharmacological, engaging, safe and enjoyable multi-modal expressive arts-based intervention approach of rehabilitation.
Examination on the relationships among bio-psycho-social-spiritual variables may help understand the complex relationships among these factors after stroke and during rehabilitation, which will contribute to the development of holistic care for stroke survivors.
This current study will adopt a 2-arm randomized controlled design with treatment-as-usual control. Upon screening for inclusion exclusion criteria, baseline data will be collected; and eligible participants will be randomized into either an 8-week Expressive Arts-based intervention group or Treatment-As-Usual control group. The control group will continue with routine rehabilitation service and have the option to participate in the Expressive Arts-based Intervention Group upon study completion. Participants will be assessed 3 times at baseline (T0), post-intervention (8th week, T1), and 6-month post-intervention (T2). The participants will complete the study in about 8 months.
- Conditions
- Stroke
- Being tested
- Expressive Arts Therapy
- Keywords
- Younger Stroke survivors, Expressive Arts Therapy, Rehabilitation, Randomized Controlled Trial, Salivary Cortisol
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive Arts TherapyBehavioural
The intervention brings together the strengths of different art modalities, such as visual art, music, movement, dance, drama and writing to assist reflect and response in individuals to their personal issues. Such variety of art forms multiplies the avenues by which a person in therapy may seek meaning, clarity, insight and healing.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This arm of participants will be receiving Expressive Arts Therapy as intervention Receives: Behavioral: Expressive Arts Therapy |
| Control | No intervention | This arm of participants will not receive any intervention and are allocated as a wait-list control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Depression and Anxiety level at 2 months and 8 months
Administration of the Chinese translated version of Hospital Anxiety and Depression Scale
- This scale is adopted to measure the level of Depression and Anxiety.
- Two scores, Depression score and Anxiety score, are generated.
- The minimum score is 0 and the maximum score is 21.
- Scores ranging from "0-7" represents "Normal", ranging from "8-10" represents "Borderline abnormal", and ranging from "11-21" represents "Abnormal".
Measured: Baseline, Month 2, and Month 8
Change of Baseline Perceived Stress level at 2 months and 8 months
Administration of Chinese translated version of Perceived Stress Scale
- This scale is adopted to measure the level of perceived stress
- The total score of Perceived Stress Scale is summing all the scores from each item, with Q4, Q5, Q7, and Q8 are reverse items.
- The minimum score is 0 and the maximum score is 40.
- Scores ranging from "0-13" represents low stress, ranging from "14-26" represents moderate stress, and "27-40" represents high perceived stress.
Measured: Baseline, Month 2, and Month 8
Change of Baseline Perceived Social Support level at 2 months and 8 months
Administration of the Chinese version of the Multidimensional Scale of Perceived Social Support
- This scale has adopted the measure the level of perceived social support from family, friends, or significant other.
- The mean score of perceived social support from "family" is calculated by summing across Q3, Q4, Q8, and Q11, then divide by 4.
- The mean score of perceived social support from "friends" is calculated by summing across Q6, Q7, Q9, and Q12, then divide by 4.
- The mean score of perceived social support from "significant other" is calculated by summing across Q1, Q2, Q5, and Q10, then divide by 4.
- The mean total score is calculated by summing across all 12 items, then divide by 12.
- The minimum mean score of each sub-score and the total score is 1 and the maximum mean score is 7.
Measured: Baseline, Month 2, and Month 8
Change of Baseline Self-esteem at 2 months and 8 months
Administration of the Chinese version of the Rosenberg Self-esteem Scale
- This scale is adopted to measure the level of self-esteem.
- Q2, Q5, Q6, Q8, Q9 are reversed items.
- Total self-esteem score is calculated by summing all items.
- The minimum score is 10 and the maximum score is 40.
- A higher score represents a higher level of self-esteem.
Measured: Baseline, Month 2, and Month 8
Change of Baseline Hope level at 2 months and 8 months
Administration of the Chinese version of the Adult State Hope Scale
- This scale is adopted to measure the level of hope.
- Pathways sub-scale score is calculated by summing across Q1, Q3, and Q5.
- Agency sub-scale score is calculated by summing across Q2, Q4, and Q6.
- Total hope score is calculated by summing all items.
- The minimum score of the sub-scales is 3 and the maximum score of the sub-scales is 24.
- The minimum score of the total score is 6 and the maximum score of the total score is 48.
- The higher scores in sub-scales represent higher levels of pathways thinking or higher agency thinking respectively. The higher total score represents higher hope levels.
Measured: Baseline, Month 2, and Month 8
Change of Baseline Spiritual well-being level at 2 months and 8 months
Administration of the Chinese version of the 3-item spiritual care sub-scale of the Body-Mind-Spirit Holistic Well-being Scale
- This sub-scale is adopted to measure the level of spiritual well-being.
- The sub-scale score is calculated by summing across all three items.
- The minimum score of this sub-scale is 3 and the maximum score of this sub-scale is 30.
- A higher score represents a higher level of spiritual well-being.
Measured: Baseline, Month 2, and Month 8
Change of Baseline Stroke-specific quality of life at 2 months and 8 months
Administration of the Chinese version of the Stroke-specific Quality of Life Short Form
- This scale is adopted to measure the level of stroke-specific Quality of Life.
- Physical components of stroke-specific Quality of Life is calculated by summing across Q1, Q2, Q4, Q7, Q10, Q11, and Q12.
- Psychosocial components of stroke-specific Qualify of life is calculated by summing across Q3, Q5, Q6, Q8, and Q9.
- The minimum score of physical and psychosocial components is 7 and 5 respectively.
- The maximum score of physical and psychosocial components is 35 and 25 respectively.
- A higher score represents a higher level of stroke-specific quality of life.
Measured: Baseline, Month 2, and Month 8
Change of Baseline general quality of life at 2 months and 8 months
Administration of the Chinese version of the 12-item Short Form Health Survey
- This scale is adopted to measure the level of health-related Quality of life.
- Q1, Q8, Q9, and Q10 are reversed items.
- Physical and Mental Health Composite Scale scores are calculated.
Measured: Baseline, Month 2, and Month 8
Change of Baseline Physical stress level and cortisol rhythm at 2 months and 8 months
Collection of saliva samples for analysis
Measured: Baseline, Month 2, and Month 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start1 Dec 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rainbow Ho, Principal investigator, Director/Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729648
- Sponsor's protocol ID
- 17609417
- Status last verified
- Apr 2023
- First submitted
- 29 Aug 2018
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chan CKP, Lo TLT, Wan AHY, Leung PPY, Pang MYC, Ho RTH. A randomised controlled trial of expressive arts-based intervention for young stroke survivors. BMC Complement Med Ther. 2021 Jan 6;21(1):7. doi: 10.1186/s12906-020-03161-6.
PubMed 33407413
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Psycho-physiological & Social-spiritual Effects of Expressive Arts-based Intervention on Young and Pre-elderly Stroke Survivors: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03729648
- Acronym / sponsor ID
- 17609417
- Conditions
- Stroke
- Keywords
- Younger Stroke survivors, Expressive Arts Therapy, Rehabilitation, Randomized Controlled Trial, Salivary Cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Nov 2018 (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.
Stroke is a devastating illness that induces numerous impairments of body function and structure, and limitations to activities in all aspects of life, thus imposing multi-faceted restrictions on one's participation in daily living. It also has detrimental impacts on one's mental health, social relationship, and quality of life. Existing research focuses primarily on older adults stroke survivors; this study is set out to contribute to current knowledge of the effectiveness of arts-based rehabilitation on younger stroke survivors. Both psychological and physiological outcomes will be examined for a comprehensive understanding on the biological, psychological, social, and spiritual changes after participating in a non-pharmacological, engaging, safe and enjoyable multi-modal expressive arts-based intervention approach of rehabilitation.This current study will adopt a 2-arm randomized controlled design with treatment-as-usual control. Upon screening for inclusion exclusion criteria, baseline data will be collected; and eligible participants will be randomized into either an 8-week Expressive Arts-based intervention group or Treatment-As-Usual control group.
Detailed description
Stroke is a devastating illness that induces numerous impairments of body function and structure, and limitations to activities in all aspects of life, thus imposing multi-faceted restrictions on one's participation in daily living. It also has detrimental impacts on one's mental health, social relationship, and quality of life. Stroke survivors often face challenges arising from the illness and its disabilities, as well as the resulting deterioration of occupational functioning. They also suffer from the psycho-spiritual sequels of loss in functioning, sense of worthlessness and hopelessness, and fear of relapse, all of which could result in mental health distress such as depression, anxiety, stress, isolation, and impaired quality of life. Though the risk of stroke increases with age, statistics have documented an increasing trend of a younger age of onset. The issues faced by younger and pre-elderly stroke survivors (<65 years old) will be even more severe due to longer term of survival, problems of resuming their occupations, and lacking of social welfare and resources for their pre-elderly age.
Existing research focuses primarily on older adults stroke survivors; this study is set out to contribute to current knowledge of the effectiveness of arts-based rehabilitation on younger stroke survivors. Both psychological and physiological outcomes will be examined for a comprehensive understanding on the biological, psychological, social, and spiritual changes after participating in a non-pharmacological, engaging, safe and enjoyable multi-modal expressive arts-based intervention approach of rehabilitation.
Examination on the relationships among bio-psycho-social-spiritual variables may help understand the complex relationships among these factors after stroke and during rehabilitation, which will contribute to the development of holistic care for stroke survivors.
This current study will adopt a 2-arm randomized controlled design with treatment-as-usual control. Upon screening for inclusion exclusion criteria, baseline data will be collected; and eligible participants will be randomized into either an 8-week Expressive Arts-based intervention group or Treatment-As-Usual control group. The control group will continue with routine rehabilitation service and have the option to participate in the Expressive Arts-based Intervention Group upon study completion. Participants will be assessed 3 times at baseline (T0), post-intervention (8th week, T1), and 6-month post-intervention (T2). The participants will complete the study in about 8 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Parallel Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Expressive Arts TherapyThis arm of participants will be receiving Expressive Arts Therapy as intervention |
| Control | No intervention | –This arm of participants will not receive any intervention and are allocated as a wait-list control group |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Presence of a single-lesion stroke in the left or right, temporal, frontal, parietal or subcortical brain region
- Experienced a major stroke event within 120 months from the time of study participation
- Diagnosis of either (a) ischemic or (b) hemorrhagic stroke
- Disability grade 1 to 4 on the Modified Rankin Scale
- With residual functions of the affected extremity
Key exclusion criteria (5 listed)
- Concurrent diagnosis of major medical or psychiatric disorders other than stroke (except depression)
- Currently receiving hospital treatment and care
- Presence of hearing or visual deficits, even with aids
- Total paralysis of the upper limbs
- Amputation of one of the limbs
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 |
|---|---|---|
| Expressive Arts TherapyThe intervention brings together the strengths of different art modalities, such as visual art, music, movement, dance, drama and writing to assist reflect and response in individuals to their personal issues. Such variety of art forms multiplies the avenues by which a person in therapy may seek meaning, clarity, insight and healing. | Behavioural | Intervention |
Primary outcome
Change from Baseline Depression and Anxiety level at 2 months and 8 months
Time frame: Baseline, Month 2, and Month 8
Administration of the Chinese translated version of Hospital Anxiety and Depression Scale * This scale is adopted to measure the level of Depression and Anxiety. * Two scores, Depression score and Anxiety score, are generated. * The minimum score is 0 and the maximum score is 21. * Scores ranging from "0-7" represents "Normal", ranging from "8-10" represents "Borderline abnormal", and ranging from "11-21" represents "Abnormal".
Change of Baseline Perceived Stress level at 2 months and 8 months
Time frame: Baseline, Month 2, and Month 8
Administration of Chinese translated version of Perceived Stress Scale * This scale is adopted to measure the level of perceived stress * The total score of Perceived Stress Scale is summing all the scores from each item, with Q4, Q5, Q7, and Q8 are reverse items. * The minimum score is 0 and the maximum score is 40. * Scores ranging from "0-13" represents low stress, ranging from "14-26" represents moderate stress, and "27-40" represents high perceived stress.
Change of Baseline Perceived Social Support level at 2 months and 8 months
Time frame: Baseline, Month 2, and Month 8
Administration of the Chinese version of the Multidimensional Scale of Perceived Social Support * This scale has adopted the measure the level of perceived social support from family, friends, or significant other. * The mean score of perceived social support from "family" is calculated by summing across Q3, Q4, Q8, and Q11, then divide by 4. * The mean score of perceived social support from "friends" is calculated by summing across Q6, Q7, Q9, and Q12, then divide by 4. * The mean score of perceived social support from "significant other" is calculated by summing across Q1, Q2, Q5, and Q10, then divide by 4. * The mean total score is calculated by summing across all 12 items, then divide by 12. * The minimum mean score of each sub-score and the total score is 1 and the maximum mean score is 7.
Change of Baseline Self-esteem at 2 months and 8 months
Time frame: Baseline, Month 2, and Month 8
Administration of the Chinese version of the Rosenberg Self-esteem Scale * This scale is adopted to measure the level of self-esteem. * Q2, Q5, Q6, Q8, Q9 are reversed items. * Total self-esteem score is calculated by summing all items. * The minimum score is 10 and the maximum score is 40. * A higher score represents a higher level of self-esteem.
Change of Baseline Hope level at 2 months and 8 months
Time frame: Baseline, Month 2, and Month 8
Administration of the Chinese version of the Adult State Hope Scale * This scale is adopted to measure the level of hope. * Pathways sub-scale score is calculated by summing across Q1, Q3, and Q5. * Agency sub-scale score is calculated by summing across Q2, Q4, and Q6. * Total hope score is calculated by summing all items. * The minimum score of the sub-scales is 3 and the maximum score of the sub-scales is 24. * The minimum score of the total score is 6 and the maximum score of the total score is 48. * The higher scores in sub-scales represent higher levels of pathways thinking or higher agency thinking respectively. The higher total score represents higher hope levels.
Change of Baseline Spiritual well-being level at 2 months and 8 months
Time frame: Baseline, Month 2, and Month 8
Administration of the Chinese version of the 3-item spiritual care sub-scale of the Body-Mind-Spirit Holistic Well-being Scale * This sub-scale is adopted to measure the level of spiritual well-being. * The sub-scale score is calculated by summing across all three items. * The minimum score of this sub-scale is 3 and the maximum score of this sub-scale is 30. * A higher score represents a higher level of spiritual well-being.
Change of Baseline Stroke-specific quality of life at 2 months and 8 months
Time frame: Baseline, Month 2, and Month 8
Administration of the Chinese version of the Stroke-specific Quality of Life Short Form * This scale is adopted to measure the level of stroke-specific Quality of Life. * Physical components of stroke-specific Quality of Life is calculated by summing across Q1, Q2, Q4, Q7, Q10, Q11, and Q12. * Psychosocial components of stroke-specific Qualify of life is calculated by summing across Q3, Q5, Q6, Q8, and Q9. * The minimum score of physical and psychosocial components is 7 and 5 respectively. * The maximum score of physical and psychosocial components is 35 and 25 respectively. * A higher score represents a higher level of stroke-specific quality of life.
Change of Baseline general quality of life at 2 months and 8 months
Time frame: Baseline, Month 2, and Month 8
Administration of the Chinese version of the 12-item Short Form Health Survey * This scale is adopted to measure the level of health-related Quality of life. * Q1, Q8, Q9, and Q10 are reversed items. * Physical and Mental Health Composite Scale scores are calculated.
Change of Baseline Physical stress level and cortisol rhythm at 2 months and 8 months
Time frame: Baseline, Month 2, and Month 8
Collection of saliva samples for analysis
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 20 Apr 2023.
- Derived from this study: PubMed 33407413Chan CKP, Lo TLT, Wan AHY, Leung PPY, Pang MYC, Ho RTH. A randomised controlled trial of expressive arts-based intervention for young stroke survivors. BMC Complement Med Ther. 2021 Jan 6;21(1):7. doi: 10.1186/s12906-020-03161-6.
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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.
Rainbow Ho principal investigator
Director/Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expressive Arts Therapy in people with Stroke, run by The University of Hong Kong at 1 site in Hong Kong.
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 7 inclusion and 5 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 20 Apr 2023. 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 Hong Kong. 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?
Change from Baseline Depression and Anxiety level at 2 months and 8 months (time frame: Baseline, Month 2, and Month 8). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03729648, which also lists 1 linked publication.
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 20 Apr 2023.