DementiaNCT03852121
Bibliotherapy for Improving Caregiving Appraisal Among Informal Caregivers of People With Dementia: A Pilot RCT
A study testing Bibliotherapy in people with Dementia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This is a 8-week pilot randomized controlled trial utilizing bibliotherapy compared with usual care to investigate the feasibility and acceptability of bibliotherapy among informal caregivers of people with dementia in China, and preliminarily examine the efficacy on improving caregiving appraisal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Bibliotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2018to 30 Aug 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caregiver who provides regular care to a person with early to moderate level of any type of medical diagnosis of dementia (PWD) for at least 5 hours per week for at least 6 months;
- Aged 18 or above;
- Not paid for the care provided;
- Assist with at least one of PWD's daily activities;
- Be able to read;
- Can be contacted by phone.
Who cannot join
- Caregivers with unstable physical or mental conditions;
- Those with cognitive impairment;
- Those involved in another interventional study.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
School of Nursing, The Hong Kong Polytechnic University
Hong Kong
About this study
Official title: Bibliotherapy for Improving Caregiving Appraisal Among Informal Caregivers of People With Dementia: A Pilot Randomized Controlled Trial
This is a 8-week pilot randomized controlled trial utilizing bibliotherapy compared with usual care to investigate the feasibility and acceptability of bibliotherapy among informal caregivers of people with dementia in China, and preliminarily examine the efficacy on improving caregiving appraisal.
Read the detailed description
Background: China is one of the countries with the highest number of people with dementia (PWD), while over 90% of PWD are cared by informal caregivers in the community. Informal caregivers are found to have higher level of stress, and lower level of well-being than non-caregivers. However, positive outcomes of caregiving have also been noted. Caregiving appraisal is caregivers' cognitive evaluation of potential caregiving stressors and the efficacy of their coping efforts related to caregiving experience. Based on Lawton's Caregiving Appraisal and Psychological Well-being Model, caregiving appraisal is an important factor that leads to the positive or negative well-being outcomes of caregivers. Addressing the caregiving appraisal of informal caregiver may be able to help in promoting the caregiver well-being and delay premature institutionalization. Intervention for improving dementia caregiving appraisal is still scarce, especially in China. Bibliotherapy is the process of learning from high-quality written materials for therapeutic benefits, it has been proved to be effective in improving caregiving appraisal of informal caregivers of people with psychosis and depression, its effect on dementia caregivers is unsure.
Objectives: There are two research objectives in this study: (1) To determine the feasibility and acceptability of the evidence-based bibliotherapy protocol among informal caregivers of PWD in China. (2) To preliminarily explore the efficacy of bibliotherapy on improving caregiving appraisal.
Methods:
Sixty participants will be recruited from Zhengzhou, China, and will be randomly allocated to either the intervention group or usual care group. The feasibility of the intervention will be explored in terms of the ease of participant recruitment, attendance rate and the attrition rate. The acceptability will be explored by interviews of participants in the intervention group at post-intervention. The Chinese version of Caregiving Appraisal Scale, the Chinese version of Ways of Coping Questionnaire, the Chinese version of Positive Aspects of Caregiving Scale, the Chinese version of Ryff's Psychological Well-being Scale, Alzheimer's Disease Knowledge Scale and Dementia Attitude Scale will be used to measure caregiving appraisal, coping, positive aspects of caregiving, psychological well-being, knowledge of dementia and attitude toward dementia of informal caregivers of PWD respectively. Descriptive statistics, Chi-square test, Mann Whitney U test, and independent t-test will be used to describe the participants' characteristics and compare the difference between groups at baseline. GEE will be used to examine the intervention efficacy.
- Conditions
- Dementia
- Being tested
- Bibliotherapy
- Keywords
- caregiving appraisal, bibliotherapy, psychological wellbeing, informal caregiver
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BibliotherapyBehavioural
Bibliotherapy is the use of reading materials for therapeutic benefits. In this study, an evidence-based modified manual will be used as the reading material. The manual adopts the self-directed problem-solving approach to dementia caregiving, examples of how other caregivers solve the specific problem for each chapter is included in the corresponding chapter. Bibliotherapy also involves guided learning by reading written information, enabling caregivers to solve their caregiving problems "step-by-step", so telephone coach is designed to figure out participants understanding, find out the unsolved problems and guide them for finding out the solution by themselves.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants will receive bibliotherapy without withdrawing from the usual care. They will be asked to read the designated manual (consists of eight chapters) within a recommended period of time (over 8 weeks). Weekly telephone coaching will also be provided to figure out participants understanding, find out the unsolved problems and guide them for finding out the solution by themselves. An orientation will be organized before the first session. Two booster sessions will be organized during the study. Receives: Behavioral: Bibliotherapy |
| Control group | No intervention | The participants in the control group will only receive usual care provided by the community health professionals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in caregiving appraisal
To be measured with the Chinese version of Caregiving Appraisal Scale (CAS). The Chinese version of CAS includes 26 items, divided into 4 subscales: caregiving burden, caregiving satisfaction, caregiving mastery, and caregiving impact. This is a 5 point Likert scale (1 = disagree a lot to 5 = agree a lot). The total score ranges from 26 to 130, with higher scores indicate more positive caregiving appraisal. The Cronbach's α for each subscale was 0.68~0.87.
Measured: At baseline, immediate post intervention
Secondary outcomes (5)
Changes in caregiver's coping
To be measured with the Chinese version of Ways of Coping Questionnaire. This questionnaire includes 20 items, divided into 2 subscales: the active coping subscale and the passive coping subscale. The passive coping subcale was recoded. The total score ranges from 0-60, higher score indicates more positive coping. It is a 4 point Likert scale (0 = never to 3 = often). The Cronbach's α was 0.90, αs for the two subscales were 0.89 and 0.78.
Measured: At baseline, immediate post intervention
Changes in caregiver's psychological well-being
To be measured with the shorter Chinese version for Ryff's Psychological Well-being Scale. This scale includes 18 items, and is divided into 6 subscales: positive relations with others, autonomy, environmental mastery, personal growth, purpose in life and self-acceptance. This scale is a Likert 6 point scale, with 1 = strongly disagree to 6 = totally agree, higher scores indicate better psychological well-being. The total score ranges from 6-108. The scale has been tested in middle-aged and older people, the Cronbach's α was 0.92 for the total scale, and at least 0.60 for each subscale.
Measured: At baseline, immediate post intervention
Changes in positive aspects of caregiving
To be measured with the Chinese version of Positive Aspects of Caregiving (C-PAC) Scale. It is a Likert 5 point scale ranging from 1 (strongly disagree) to 5 (strongly agree) regarding the extent to which providing care to their relatives with dementia had enabled them "feel important", "feel appreciated" etc. The scale has 11 items, divided into two subscales: enriching life and affirming self. The total score ranges from 5-55. The Cronbach's α was 0.89 for the total scale, the αs for enriching life and affirming self subscales were 0.85 and 0.84 respectively.
Measured: At baseline, immediate post intervention
Changes in knowledge of dementia
To be measured with the Chinese version of Alzheimer's Disease Knowledge Scale. This scale has 30 items, with "true" or "false" choices for each item. The total score ranges from 0-30. Higher score indicates more knowledgement about dementia. The Cronbach's a was 0.785.
Measured: At baseline, immediate post intervention
Changes in attitude toward dementia
To be measured with the Chinese version of Dementia Attitude Scale. This is a 20-item Likert 7 point scale (1=strongly disagree, 7=strongly agree). The total score ranges from 20-140, higher scores indicate more positive attitude toward dementia. The Cronbach's α was 0.818.
Measured: At baseline, immediate post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start1 Dec 2018
- Primary completion30 Sep 2019
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Daphne Cheung, The Hong Kong Polytechnic University
- Investigators
- Daphne Cheung, PhD, Principal investigator, School of Nursing, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852121
- Sponsor's protocol ID
- HSEARS20181120001
- Status last verified
- Oct 2020
- First submitted
- 4 Feb 2019
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol. 2010 Jul 16;10:67. doi: 10.1186/1471-2288-10-67.
PubMed 20637084Bilich LL, Deane FP, Phipps AB, Barisic M, Gould G. Effectiveness of bibliotherapy self-help for depression with varying levels of telephone helpline support. Clin Psychol Psychother. 2008 Mar-Apr;15(2):61-74. doi: 10.1002/cpp.562.
PubMed 19115429Campbell LF, Smith TP. Integrating self-help books into psychotherapy. J Clin Psychol. 2003 Feb;59(2):177-86. doi: 10.1002/jclp.10140.
PubMed 12552626Folkman, S., & Lazarus, R. S. (1988). Ways of coping questionnaire: Consulting Psychologists Press.
Hsiao HY, Liu Z, Xu L, Huang Y, Chi I. Knowledge, Attitudes, and Clinical Practices for Patients With Dementia Among Mental Health Providers in China: City and Town Differences. Gerontol Geriatr Educ. 2016 Oct-Dec;37(4):342-358. doi: 10.1080/02701960.2014.990152. Epub 2015 Jan 27.
PubMed 25625718Lawton MP, Kleban MH, Moss M, Rovine M, Glicksman A. Measuring caregiving appraisal. J Gerontol. 1989 May;44(3):P61-71. doi: 10.1093/geronj/44.3.p61.
PubMed 2715587Lawton MP, Moss M, Kleban MH, Glicksman A, Rovine M. A two-factor model of caregiving appraisal and psychological well-being. J Gerontol. 1991 Jul;46(4):P181-9. doi: 10.1093/geronj/46.4.p181.
PubMed 2071844Lazarus, R. S., & Folkman, S. (1986). Stress, appraisal, and coping. New York: pringer.
Li, R.-H. (2014). Reliability and validity of a shorter Chinese version for Ryff's psychological well-being scale. Health Education Journal, 73(4), 446-452.
Lou VW, Lau BH, Cheung KS. Positive aspects of caregiving (PAC): scale validation among Chinese dementia caregivers (CG). Arch Gerontol Geriatr. 2015 Mar-Apr;60(2):299-306. doi: 10.1016/j.archger.2014.10.019. Epub 2014 Nov 7.
PubMed 25488014Sclan SG, Reisberg B. Functional assessment staging (FAST) in Alzheimer's disease: reliability, validity, and ordinality. Int Psychogeriatr. 1992;4 Suppl 1:55-69. doi: 10.1017/s1041610292001157.
PubMed 1504288Shechtman, Z. (2009). Bibliotherapy as a Method of Treatment. In Treating Child and Adolescent Aggression Through Bibliotherapy (pp. 1-17).
Wang S, Cheung DSK, Leung AYM. Overview of dementia care under the three-tier long-term care system of China. Public Health Nurs. 2019 Mar;36(2):199-206. doi: 10.1111/phn.12573. Epub 2018 Dec 13.
PubMed 30549090Zheng X, Chung JO, Woo BK. Exploring the Impact of a Culturally Tailored Short Film in Modifying Dementia Stigma Among Chinese Americans: A Pilot Study. Acad Psychiatry. 2016 Apr;40(2):372-4. doi: 10.1007/s40596-015-0397-7. Epub 2015 Aug 26.
PubMed 26307362
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bibliotherapy for Improving Caregiving Appraisal Among Informal Caregivers of People With Dementia: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03852121
- Acronym / sponsor ID
- HSEARS20181120001
- Conditions
- Dementia
- Keywords
- caregiving appraisal, bibliotherapy, psychological wellbeing, informal caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 25 Feb 2019 (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.
This is a 8-week pilot randomized controlled trial utilizing bibliotherapy compared with usual care to investigate the feasibility and acceptability of bibliotherapy among informal caregivers of people with dementia in China, and preliminarily examine the efficacy on improving caregiving appraisal.
Detailed description
Background: China is one of the countries with the highest number of people with dementia (PWD), while over 90% of PWD are cared by informal caregivers in the community. Informal caregivers are found to have higher level of stress, and lower level of well-being than non-caregivers. However, positive outcomes of caregiving have also been noted. Caregiving appraisal is caregivers' cognitive evaluation of potential caregiving stressors and the efficacy of their coping efforts related to caregiving experience. Based on Lawton's Caregiving Appraisal and Psychological Well-being Model, caregiving appraisal is an important factor that leads to the positive or negative well-being outcomes of caregivers. Addressing the caregiving appraisal of informal caregiver may be able to help in promoting the caregiver well-being and delay premature institutionalization. Intervention for improving dementia caregiving appraisal is still scarce, especially in China. Bibliotherapy is the process of learning from high-quality written materials for therapeutic benefits, it has been proved to be effective in improving caregiving appraisal of informal caregivers of people with psychosis and depression, its effect on dementia caregivers is unsure.
Objectives: There are two research objectives in this study: (1) To determine the feasibility and acceptability of the evidence-based bibliotherapy protocol among informal caregivers of PWD in China. (2) To preliminarily explore the efficacy of bibliotherapy on improving caregiving appraisal.
Methods:
Sixty participants will be recruited from Zhengzhou, China, and will be randomly allocated to either the intervention group or usual care group. The feasibility of the intervention will be explored in terms of the ease of participant recruitment, attendance rate and the attrition rate. The acceptability will be explored by interviews of participants in the intervention group at post-intervention. The Chinese version of Caregiving Appraisal Scale, the Chinese version of Ways of Coping Questionnaire, the Chinese version of Positive Aspects of Caregiving Scale, the Chinese version of Ryff's Psychological Well-being Scale, Alzheimer's Disease Knowledge Scale and Dementia Attitude Scale will be used to measure caregiving appraisal, coping, positive aspects of caregiving, psychological well-being, knowledge of dementia and attitude toward dementia of informal caregivers of PWD respectively. Descriptive statistics, Chi-square test, Mann Whitney U test, and independent t-test will be used to describe the participants' characteristics and compare the difference between groups at baseline. GEE will be used to examine the intervention efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: BibliotherapyParticipants will receive bibliotherapy without withdrawing from the usual care. They will be asked to read the designated manual (consists of eight chapters) within a recommended period of time (over 8 weeks). Weekly telephone coaching will also be provided to figure out participants understanding, find out the unsolved problems and guide them for finding out the solution by themselves. An orientation will be organized before the first session. Two booster sessions will be organized during the study. |
| Control group | No intervention | –The participants in the control group will only receive usual care provided by the community health professionals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Caregiver who provides regular care to a person with early to moderate level of any type of medical diagnosis of dementia (PWD) for at least 5 hours per week for at least 6 months;
- Aged 18 or above;
- Not paid for the care provided;
- Assist with at least one of PWD's daily activities;
- Be able to read;
Key exclusion criteria (3 listed)
- Caregivers with unstable physical or mental conditions;
- Those with cognitive impairment;
- Those involved in another interventional study.
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 |
|---|---|---|
| BibliotherapyBibliotherapy is the use of reading materials for therapeutic benefits. In this study, an evidence-based modified manual will be used as the reading material. The manual adopts the self-directed problem-solving approach to dementia caregiving, examples of how other caregivers solve the specific problem for each chapter is included in the corresponding chapter. Bibliotherapy also involves guided learning by reading written information, enabling caregivers to solve their caregiving problems "step-by-step", so telephone coach is designed to figure out participants understanding, find out the unsolved problems and guide them for finding out the solution by themselves. | Behavioural | Intervention group |
Primary outcome
Changes in caregiving appraisal
Time frame: At baseline, immediate post intervention
To be measured with the Chinese version of Caregiving Appraisal Scale (CAS). The Chinese version of CAS includes 26 items, divided into 4 subscales: caregiving burden, caregiving satisfaction, caregiving mastery, and caregiving impact. This is a 5 point Likert scale (1 = disagree a lot to 5 = agree a lot). The total score ranges from 26 to 130, with higher scores indicate more positive caregiving appraisal. The Cronbach's α for each subscale was 0.68~0.87.
5 secondary outcomes
Changes in caregiver's coping
Time frame: At baseline, immediate post intervention
Changes in caregiver's psychological well-being
Time frame: At baseline, immediate post intervention
Changes in positive aspects of caregiving
Time frame: At baseline, immediate post intervention
Changes in knowledge of dementia
Time frame: At baseline, immediate post intervention
Changes in attitude toward dementia
Time frame: At baseline, immediate post intervention
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 19 Oct 2020.
- Background: PubMed 20637084Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol. 2010 Jul 16;10:67. doi: 10.1186/1471-2288-10-67.
- Background: PubMed 19115429Bilich LL, Deane FP, Phipps AB, Barisic M, Gould G. Effectiveness of bibliotherapy self-help for depression with varying levels of telephone helpline support. Clin Psychol Psychother. 2008 Mar-Apr;15(2):61-74. doi: 10.1002/cpp.562.
- Background: PubMed 12552626Campbell LF, Smith TP. Integrating self-help books into psychotherapy. J Clin Psychol. 2003 Feb;59(2):177-86. doi: 10.1002/jclp.10140.
- BackgroundFolkman, S., & Lazarus, R. S. (1988). Ways of coping questionnaire: Consulting Psychologists Press.
- Background: PubMed 25625718Hsiao HY, Liu Z, Xu L, Huang Y, Chi I. Knowledge, Attitudes, and Clinical Practices for Patients With Dementia Among Mental Health Providers in China: City and Town Differences. Gerontol Geriatr Educ. 2016 Oct-Dec;37(4):342-358. doi: 10.1080/02701960.2014.990152. Epub 2015 Jan 27.
- Background: PubMed 2715587Lawton MP, Kleban MH, Moss M, Rovine M, Glicksman A. Measuring caregiving appraisal. J Gerontol. 1989 May;44(3):P61-71. doi: 10.1093/geronj/44.3.p61.
- Background: PubMed 2071844Lawton MP, Moss M, Kleban MH, Glicksman A, Rovine M. A two-factor model of caregiving appraisal and psychological well-being. J Gerontol. 1991 Jul;46(4):P181-9. doi: 10.1093/geronj/46.4.p181.
- BackgroundLazarus, R. S., & Folkman, S. (1986). Stress, appraisal, and coping. New York: pringer.
- BackgroundLi, R.-H. (2014). Reliability and validity of a shorter Chinese version for Ryff's psychological well-being scale. Health Education Journal, 73(4), 446-452.
- Background: PubMed 25488014Lou VW, Lau BH, Cheung KS. Positive aspects of caregiving (PAC): scale validation among Chinese dementia caregivers (CG). Arch Gerontol Geriatr. 2015 Mar-Apr;60(2):299-306. doi: 10.1016/j.archger.2014.10.019. Epub 2014 Nov 7.
- Background: PubMed 1504288Sclan SG, Reisberg B. Functional assessment staging (FAST) in Alzheimer's disease: reliability, validity, and ordinality. Int Psychogeriatr. 1992;4 Suppl 1:55-69. doi: 10.1017/s1041610292001157.
- BackgroundShechtman, Z. (2009). Bibliotherapy as a Method of Treatment. In Treating Child and Adolescent Aggression Through Bibliotherapy (pp. 1-17).
- Individual participant dataSharing planned: No
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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.
Daphne Cheung, PhD principal investigator
School of Nursing, The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bibliotherapy in people with Dementia, run by The Hong Kong Polytechnic University 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 6 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 19 Oct 2020. 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?
Changes in caregiving appraisal (time frame: At baseline, immediate post intervention). 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 NCT03852121, which also lists 14 linked publications.
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 19 Oct 2020.