Diabetes MellitusNCT05291026
Mobile Health Intervention for Improved Adherence in Type 2 Diabetes
A study testing mobile phone-based health information in people with Diabetes Mellitus, run by Obafemi Awolowo University at 1 site in Nigeria.
Trial summary
The study assessed patients' glycemic control, knowledge of type 2 diabetes (T2D) and adherence to medications, and evaluated the impact of a mobile telephone-based intervention on these indices. Patients' clinic attendance and pharmacy refill records were reviewed for the period of 1 year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- mobile phone-based health information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNigeria
- Study dates
- 15 Dec 2018to 1 Jul 2019
- 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
- Diagnosed of type 2 diabetes for the first time in the month following baseline study
- Male or female, 18 yeas of age and above
- Enrolled in the Out-patient Diabetes Clinic of the Teaching Hospital
- Gave informed consent to participate.
Who cannot join
- Diagnosed of other disease conditions outside type 2 diabetes
- Below 18 years of age
- Not enrolled in the Out-patient Diabetes Clinic of the Teaching Hospital
- Did not give informed consent
Trial locations and contacts
1 site in 1 country.
Nigeria1 site
Obafemi Awolowo University Teaching Hospital Complex
Ile-Ife, Osun State, 234
About this study
Official title: Evaluation of mHealth Intervention to Improve Medication Adherence in Type 2 Diabetes in Nigeria: a Randomized Controlled Trial
The study assessed patients' glycemic control, knowledge of type 2 diabetes (T2D) and adherence to medications, and evaluated the impact of a mobile telephone-based intervention on these indices. Patients' clinic attendance and pharmacy refill records were reviewed for the period of 1 year. Then over a period of 1 month, newly diagnosed T2D patients were enrolled in the prospective phase of the study and randomized into control and intervention groups. A mobile phone-based health education and follow-up package was applied to the intervention group alone for a period of 6 months. Afterwards, both groups were assessed and compared on the study outcome parameters. Same questionnaires were used pre- and post-intervention for primary data collection. Descriptive and inferential statistics were used for data analysis.
Read the detailed description
Objectives of the Study: The study assessed patients' glycemic control, knowledge of type 2 diabetes (T2D) and adherence to medications, and evaluated the impact of a mobile telephone-based intervention on these indices.
Study design: Randomized controlled trial Study Setting: Diabetes Clinic, Endocrinology Unit, Department of Internal Medicine, Obafemi Awolowo University Teaching Hospital Ile Ife, Osun State Nigeria The study was structured in five stages. Study Duration: Seven months Stage 1: Baseline data Task 1: Baseline data for patients' glycemic control were obtained from one-year retrospective review of 1392 patients' files for glycated haemoglobin (HbA1c) measurements.
Task 2: Patients' baseline adherence data were obtained from one-year retrospective review of pharmacy refill records (clinic attendance) Task 3: Development and validation of research instruments (Questionnaires, Short Message Services (SMS).
Task 4: Recruitment and training of research assistants (2 hours daily for 3 days) Stage 2: Recruitment and randomization of participants Task 1: Enrolment of all newly-diagnosed patients (n = 120), enrolled in the Diabetes Clinic in the period of one month following Stage 1 Task 2: Obtaining of informed consent from all newly-diagnosed patients enrolled in the Diabetes Clinic in the one month following Stage 1 Task 3: Collection of participants' baseline knowledge data using structured questionnaire Task 4: Collection of baseline self-reported adherence data using the adapted 8-point Morisky Medication Adherence Scale (MMAS-8) instrument Task 5: Randomization of consenting participants into two equal (n = 60) control and intervention groups using a randomization software Stage 3: Intervention Task 1: Activation of short message services to participants in the intervention cohort at a frequency of one message per day for the period of 6 months.
Task 2: Follow up on clinic attendances of all participants for the period of 6 months Stage 4: Post-Intervention Review Task 1: Repeat administration of same questionnaires originally administered at Stage 2 to all participants Task 1: Review of participants' clinic attendance and pharmacy refill records Task 2: Review of participants HbA1c measurements from their records Stage 5: Data analysis Task 1: Demographic variables of participants were analyzed using descriptive statistics including frequency and percentages Task 2: Weighted mean scores were used to analyze knowledge and adherence scores Task 3: Two-sample t-test was used to compare pre- and post-intervention scores of knowledge and adherence Task 4: Chi square test was conducted to analyze associations between demographic variables and self-reported adherence data Task 5: Statistical package for the social sciences (SPSS) version 21 for windows software was used for data analysis at the p < 0.05 level of significance
- Conditions
- Diabetes Mellitus
- Being tested
- mobile phone-based health information
- Keywords
- mobile health, type 2 diabetes, adherence, health education, follow-up
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile phone-based health informationOther
Also called health education, follow-up messaging
health education and follow-up messaging, randomly assigned to each participant in the intervention arm using a randomization software, delivered once daily, as short message service (sms)
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Type 2 diabetes patients, 18 years old and above, enrolled in the out-patient, diabetes clinic of the tertiary health facility, receiving only standard of care, and who gave their informed consent |
| intervention group | Experimental | type 2 diabetes patients, 18 years old and above, enrolled in the out-patient diabetes clinic of the tertiary health facility, receiving standard of care in addition to a mobile phone - based health education and follow-up messaging on a frequency of once a day corresponding to how often they are expected to take their medications (that is every day), and who gave their informed consent. Receives: Other: mobile phone-based health information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure
Reduction in glycated hemoglobin (HbA1c), measured using blood tests, expressed in mmol/mol (%)
Measured: 6 Months
Secondary outcomes (2)
Secondary outcome measure I
Knowledge of diabetes, measured as by the mean score of participants in a questionnaire-based survey
Measured: 6 months
Secondary outcome measure II
Adherence to medication, measured by the mean score of participants in a questionnaire-based survey
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start15 Dec 2018
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All newly-diagnosed type 2 diabetes patients within the one month period following the retrospective document review, were enrolled, provided they gave their informed consent. Study participants were randomly assigned to either of two equal-sized control and intervention cohorts. The Randomizer App software was used to assign participants to the control and intervention groups. The control group received standard of care only. The intervention group received the standard of care in addition to the mobile phone-based health education and follow-up messaging at the frequency of once daily for 6 months.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Obafemi Awolowo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madu Ihekoronye, Obafemi Awolowo University
- Investigators
- Kanayo Osemene, Ph.D., Study director, Department of Clinical Pharmacy and Pharmacy Administration, Obafemi Awolowo University, Ile Ife Nigeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291026
- Sponsor's protocol ID
- mH22000
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared
Publications
Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR. Management of hyperglycaemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2012 Jun;55(6):1577-96. doi: 10.1007/s00125-012-2534-0. Epub 2012 Apr 20. No abstract available.
PubMed 22526604Kharroubi AT, Darwish HM. Diabetes mellitus: The epidemic of the century. World J Diabetes. 2015 Jun 25;6(6):850-67. doi: 10.4239/wjd.v6.i6.850.
PubMed 26131326Olawuyi AT, Adeoye IA. The prevalence and associated factors of non-communicable disease risk factors among civil servants in Ibadan, Nigeria. PLoS One. 2018 Sep 13;13(9):e0203587. doi: 10.1371/journal.pone.0203587. eCollection 2018.
PubMed 30212508World Health Organization. Diabetes [Internet]. World Health Organisation, Geneva Switzerland; 2018. Available from: https://www.who.int/news-room/factsheets/ detail/diabetes
World Health Organisation. World malaria report 2015. World Health Organisation, Geneva Switzerland; 2016.
Asche C, LaFleur J, Conner C. A review of diabetes treatment adherence and the association with clinical and economic outcomes. Clin Ther. 2011 Jan;33(1):74-109. doi: 10.1016/j.clinthera.2011.01.019.
PubMed 21397776Harande Y. Exploring the Literature of Diabetes in Nigeria: A Bibliometrics Study. African Journal of Diabetes Medicine. 2011; 2:1-4.
Mouhtadi BB, Alame MM, Malaeb B, Hallit S, Salameh P, Malaeb D. Physician-community pharmacist collaborative care in diabetes management: a pilot study. J Drug Assess. 2018 Oct 23;7(1):61-65. doi: 10.1080/21556660.2018.1535437. eCollection 2018.
PubMed 30370175Marciano L, Camerini AL, Schulz PJ. The Role of Health Literacy in Diabetes Knowledge, Self-Care, and Glycemic Control: a Meta-analysis. J Gen Intern Med. 2019 Jun;34(6):1007-1017. doi: 10.1007/s11606-019-04832-y. Epub 2019 Mar 15.
PubMed 30877457Caruso R, Magon A, Baroni I, Dellafiore F, Arrigoni C, Pittella F, Ausili D. Health literacy in type 2 diabetes patients: a systematic review of systematic reviews. Acta Diabetol. 2018 Jan;55(1):1-12. doi: 10.1007/s00592-017-1071-1. Epub 2017 Nov 11.
PubMed 29129000Ramaj A, Kamberi F, Behrens J. Effects of Diabetes Education on Emotional Distress in Patients with Type 2 Diabetes-An Experimental Study. Open Journal of Endocrine and Metabolic Diseases. 2019 Feb 19; 9(2):9-20.
Hong JS, Kang HC. Relationship between oral antihyperglycemic medication adherence and hospitalization, mortality, and healthcare costs in adult ambulatory care patients with type 2 diabetes in South Korea. Med Care. 2011 Apr;49(4):378-84. doi: 10.1097/MLR.0b013e31820292d1.
PubMed 21368684Hansen RA, Farley JF, Droege M, Maciejewski ML. A retrospective cohort study of economic outcomes and adherence to monotherapy with metformin, pioglitazone, or a sulfonylurea among patients with type 2 diabetes mellitus in the United States from 2003 to 2005. Clin Ther. 2010 Jul;32(7):1308-19. doi: 10.1016/j.clinthera.2010.07.011.
PubMed 20678679Juarez DT, Tan C, Davis J, Mau M. Factors Affecting Sustained Medication Adherence and Its Impact on Health Care Utilization in Patients with Diabetes. J Pharm Health Serv Res. 2013 Jun;4(2):89-94. doi: 10.1111/jphs.12016.
PubMed 23717343Garcia-Perez LE, Alvarez M, Dilla T, Gil-Guillen V, Orozco-Beltran D. Adherence to therapies in patients with type 2 diabetes. Diabetes Ther. 2013 Dec;4(2):175-94. doi: 10.1007/s13300-013-0034-y. Epub 2013 Aug 30.
PubMed 23990497
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of mHealth Intervention to Improve Medication Adherence in Type 2 Diabetes in Nigeria: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05291026
- Acronym / sponsor ID
- mH22000
- Conditions
- Diabetes Mellitus
- Keywords
- mobile health, type 2 diabetes, adherence, health education, follow-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Obafemi Awolowo UniversityUniversity, hospital or other
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 22 Mar 2022 (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 study assessed patients' glycemic control, knowledge of type 2 diabetes (T2D) and adherence to medications, and evaluated the impact of a mobile telephone-based intervention on these indices. Patients' clinic attendance and pharmacy refill records were reviewed for the period of 1 year. Then over a period of 1 month, newly diagnosed T2D patients were enrolled in the prospective phase of the study and randomized into control and intervention groups. A mobile phone-based health education and follow-up package was applied to the intervention group alone for a period of 6 months. Afterwards, both groups were assessed and compared on the study outcome parameters. Same questionnaires were used pre- and post-intervention for primary data collection. Descriptive and inferential statistics were used for data analysis.
Detailed description
Objectives of the Study: The study assessed patients' glycemic control, knowledge of type 2 diabetes (T2D) and adherence to medications, and evaluated the impact of a mobile telephone-based intervention on these indices.
Study design: Randomized controlled trial Study Setting: Diabetes Clinic, Endocrinology Unit, Department of Internal Medicine, Obafemi Awolowo University Teaching Hospital Ile Ife, Osun State Nigeria The study was structured in five stages. Study Duration: Seven months Stage 1: Baseline data Task 1: Baseline data for patients' glycemic control were obtained from one-year retrospective review of 1392 patients' files for glycated haemoglobin (HbA1c) measurements.
Task 2: Patients' baseline adherence data were obtained from one-year retrospective review of pharmacy refill records (clinic attendance) Task 3: Development and validation of research instruments (Questionnaires, Short Message Services (SMS).
Task 4: Recruitment and training of research assistants (2 hours daily for 3 days) Stage 2: Recruitment and randomization of participants Task 1: Enrolment of all newly-diagnosed patients (n = 120), enrolled in the Diabetes Clinic in the period of one month following Stage 1 Task 2: Obtaining of informed consent from all newly-diagnosed patients enrolled in the Diabetes Clinic in the one month following Stage 1 Task 3: Collection of participants' baseline knowledge data using structured questionnaire Task 4: Collection of baseline self-reported adherence data using the adapted 8-point Morisky Medication Adherence Scale (MMAS-8) instrument Task 5: Randomization of consenting participants into two equal (n = 60) control and intervention groups using a randomization software Stage 3: Intervention Task 1: Activation of short message services to participants in the intervention cohort at a frequency of one message per day for the period of 6 months.
Task 2: Follow up on clinic attendances of all participants for the period of 6 months Stage 4: Post-Intervention Review Task 1: Repeat administration of same questionnaires originally administered at Stage 2 to all participants Task 1: Review of participants' clinic attendance and pharmacy refill records Task 2: Review of participants HbA1c measurements from their records Stage 5: Data analysis Task 1: Demographic variables of participants were analyzed using descriptive statistics including frequency and percentages Task 2: Weighted mean scores were used to analyze knowledge and adherence scores Task 3: Two-sample t-test was used to compare pre- and post-intervention scores of knowledge and adherence Task 4: Chi square test was conducted to analyze associations between demographic variables and self-reported adherence data Task 5: Statistical package for the social sciences (SPSS) version 21 for windows software was used for data analysis at the p < 0.05 level of significance
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- All newly-diagnosed type 2 diabetes patients within the one month period following the retrospective document review, were enrolled, provided they gave their informed consent. Study participants were randomly assigned to either of two equal-sized control and intervention cohorts. The Randomizer App software was used to assign participants to the control and intervention groups. The control group received standard of care only. The intervention group received the standard of care in addition to the mobile phone-based health education and follow-up messaging at the frequency of once daily for 6 months.
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Type 2 diabetes patients, 18 years old and above, enrolled in the out-patient, diabetes clinic of the tertiary health facility, receiving only standard of care, and who gave their informed consent |
| intervention group | Experimental | Other: mobile phone-based health informationtype 2 diabetes patients, 18 years old and above, enrolled in the out-patient diabetes clinic of the tertiary health facility, receiving standard of care in addition to a mobile phone - based health education and follow-up messaging on a frequency of once a day corresponding to how often they are expected to take their medications (that is every day), and who gave their informed consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed of type 2 diabetes for the first time in the month following baseline study
- Male or female, 18 yeas of age and above
- Enrolled in the Out-patient Diabetes Clinic of the Teaching Hospital
- Gave informed consent to participate.
Key exclusion criteria (4 listed)
- Diagnosed of other disease conditions outside type 2 diabetes
- Below 18 years of age
- Not enrolled in the Out-patient Diabetes Clinic of the Teaching Hospital
- Did not give informed consent
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 |
|---|---|---|
| mobile phone-based health informationAlso: health education, follow-up messaginghealth education and follow-up messaging, randomly assigned to each participant in the intervention arm using a randomization software, delivered once daily, as short message service (sms) | Other | intervention group |
Primary outcome
Primary outcome measure
Time frame: 6 Months
Reduction in glycated hemoglobin (HbA1c), measured using blood tests, expressed in mmol/mol (%)
2 secondary outcomes
Secondary outcome measure I
Time frame: 6 months
Secondary outcome measure II
Time frame: 6 months
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 4 Apr 2022.
- Background: PubMed 22526604Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR. Management of hyperglycaemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2012 Jun;55(6):1577-96. doi: 10.1007/s00125-012-2534-0. Epub 2012 Apr 20. No abstract available.
- Background: PubMed 26131326Kharroubi AT, Darwish HM. Diabetes mellitus: The epidemic of the century. World J Diabetes. 2015 Jun 25;6(6):850-67. doi: 10.4239/wjd.v6.i6.850.
- Background: PubMed 30212508Olawuyi AT, Adeoye IA. The prevalence and associated factors of non-communicable disease risk factors among civil servants in Ibadan, Nigeria. PLoS One. 2018 Sep 13;13(9):e0203587. doi: 10.1371/journal.pone.0203587. eCollection 2018.
- BackgroundWorld Health Organization. Diabetes [Internet]. World Health Organisation, Geneva Switzerland; 2018. Available from: https://www.who.int/news-room/factsheets/ detail/diabetes
- BackgroundWorld Health Organisation. World malaria report 2015. World Health Organisation, Geneva Switzerland; 2016.
- Background: PubMed 21397776Asche C, LaFleur J, Conner C. A review of diabetes treatment adherence and the association with clinical and economic outcomes. Clin Ther. 2011 Jan;33(1):74-109. doi: 10.1016/j.clinthera.2011.01.019.
- BackgroundHarande Y. Exploring the Literature of Diabetes in Nigeria: A Bibliometrics Study. African Journal of Diabetes Medicine. 2011; 2:1-4.
- Background: PubMed 30370175Mouhtadi BB, Alame MM, Malaeb B, Hallit S, Salameh P, Malaeb D. Physician-community pharmacist collaborative care in diabetes management: a pilot study. J Drug Assess. 2018 Oct 23;7(1):61-65. doi: 10.1080/21556660.2018.1535437. eCollection 2018.
- Background: PubMed 30877457Marciano L, Camerini AL, Schulz PJ. The Role of Health Literacy in Diabetes Knowledge, Self-Care, and Glycemic Control: a Meta-analysis. J Gen Intern Med. 2019 Jun;34(6):1007-1017. doi: 10.1007/s11606-019-04832-y. Epub 2019 Mar 15.
- Background: PubMed 29129000Caruso R, Magon A, Baroni I, Dellafiore F, Arrigoni C, Pittella F, Ausili D. Health literacy in type 2 diabetes patients: a systematic review of systematic reviews. Acta Diabetol. 2018 Jan;55(1):1-12. doi: 10.1007/s00592-017-1071-1. Epub 2017 Nov 11.
- BackgroundRamaj A, Kamberi F, Behrens J. Effects of Diabetes Education on Emotional Distress in Patients with Type 2 Diabetes-An Experimental Study. Open Journal of Endocrine and Metabolic Diseases. 2019 Feb 19; 9(2):9-20.
- Background: PubMed 21368684Hong JS, Kang HC. Relationship between oral antihyperglycemic medication adherence and hospitalization, mortality, and healthcare costs in adult ambulatory care patients with type 2 diabetes in South Korea. Med Care. 2011 Apr;49(4):378-84. doi: 10.1097/MLR.0b013e31820292d1.
- Individual participant dataSharing planned: No. IPD will not be shared
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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.
Kanayo Osemene, Ph.D. study director
Department of Clinical Pharmacy and Pharmacy Administration, Obafemi Awolowo University, Ile Ife Nigeria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile phone-based health information in people with Diabetes Mellitus, run by Obafemi Awolowo University at 1 site in Nigeria.
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: finished, as of the sponsor's last update on 4 Apr 2022. 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 Nigeria. 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?
Primary outcome measure (time frame: 6 Months). 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 NCT05291026, which also lists 45 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 4 Apr 2022.