Type 2 Diabetes MellitusBEHOLD-16NCT03164538
A Psychological-behavioral Intervention to Increase Activity in Type 2 Diabetes
A study testing Positive Psychology + Motivational Interviewing and Diabetes Education in people with Type 2 Diabetes Mellitus, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The focus of this study is to examine the feasibility, acceptability, and impact of a customized, combined positive psychology and motivational interviewing (PP-MI) health behavior intervention in a group of patients with type 2 diabetes (T2D). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Positive Psychology + Motivational Interviewing and Diabetes Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2017to 10 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- T2D. Eligible patients will meet American Diabetes Association (ADA) criteria for T2D (e.g., HbA1c [A1C] ≥6.5%, fasting glucose ≥126 mg/d), with diagnosis confirmed by their diabetes clinician and/or medical record review.
- Low physical activity. Low physical activity will be defined as ≤150 minutes/week of MVPA (corresponding to ADA recommendations for moderate or greater intensity aerobic physical activity). Physical activity will be measured using a brief questionnaire adapted from the International Physical Activity Questionnaire (IPAQ).
Who cannot join
- Cognitive impairment precluding consent or meaningful participation.
- Lack of phone availability.
- Inability to read/write in English.
- Additional medical conditions (e.g., severe arthritis) that preclude physical activity.
- Enrollment in mind-body programs, lifestyle intervention programs (e.g., cardiac rehabilitation), or other clinical trials.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Psychological-behavioral Intervention to Increase Activity in Type 2 Diabetes: a 16-week Randomized Controlled Trial
The focus of this study is to examine the feasibility, acceptability, and impact of a customized, combined positive psychology and motivational interviewing (PP-MI) health behavior intervention in a group of patients with type 2 diabetes (T2D).
Read the detailed description
The investigators will compare a combined positive psychology and motivational interviewing (PP-MI) intervention that is adapted for patients with T2D to a diabetes education intervention (control) in a randomized controlled trial. The investigators will enroll 70 participants, who will be randomized to either a 16-week PP-MI health behavior intervention or an 16-week diabetes education intervention.
In this project, the investigators plan to do the following:
- Examine the feasibility and acceptability of a 16-week, telephone-delivered health behavior intervention utilizing PP exercises and MI with systematic goal-setting.
- Determine whether the PP-MI intervention leads to greater increases in physical activity than the education intervention in T2D patients.
- Explore the impact of the PP-MI intervention on other psychological, behavioral, and medical outcomes, compared to the education intervention.
Participants will undergo an initial screening visit during which they will meet with study staff in person. At this visit, study eligibility will be confirmed, and eligible and willing participants will be enrolled. Following enrollment, participants will complete self-report measures, and vital signs and A1c will be measured. They then will take home and wear an accelerometer for one week, to measure baseline physical activity.
Baseline information about enrolled participants will be obtained from the participants, care providers, and the electronic medical record as required for characterization of the population. This information will include data regarding medical history (type 2 diabetes mellitus), current medical variables (conditions affecting physical activity), medications, and sociodemographic data (age, gender, race/ethnicity, living alone).
Participants will undergo a second in-person visit once adequate baseline physical activity data has been obtained. In this visit, accelerometer data will be reviewed to ensure that adequate baseline activity was captured. If so, participants will be randomized to either the PP-MI or diabetes education condition, then begin the study intervention. During this second in-person visit, participants will receive either a PP-MI or diabetes education treatment manual, depending on randomization.
For the PP-MI intervention:
For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. At subsequent sessions, participants will review the prior week's PP exercise and learn about a new exercise, then will review the prior week's physical activity goal and set a new one.
For the diabetes education intervention:
Each week, participants will learn about a different health behavior topic related to diabetes health. This includes information about diabetes self-monitoring, medication adherence, having a heart-healthy diet, and being physically active.
Participants will complete the remaining sessions by phone approximately weekly over the next 16 weeks. Phone sessions will last approximately 30 minutes, with PP-MI and physical activity assignments completed between phone sessions. PP and MI will be delivered step-wise within sessions (rather than intertwined) based on our experience, participant feedback, and pilot work. If a week is missed, the session will not be skipped, but rather the intervention will be completed sequentially (with participants who miss weeks then missing the final sessions), with the exception of the final visit, which skips to Planning for the Future in all cases.
Participants will undergo an in-person follow-up assessment at 16 weeks. At this session, participants will repeat self-report assessments that were administered at baseline. Vital signs and a blood sample will again be collected at this in-person visit. Prior to this assessment, participants will wear an accelerometer for 7 days to measure physical activity. Participants will also undergo a phone follow-up assessment at 24 weeks. During this session over the phone, participants will repeat self-report assessments that were administered at baseline. Finally, prior to this follow-up, participants will wear another accelerometer for 7 days to measure physical activity.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Positive Psychology + Motivational Interviewing, Diabetes Education
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Psychology + Motivational InterviewingBehavioural
Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions. PP and MI components will be delivered stepwise within sessions (rather than intertwined).
Diabetes EducationBehavioural
Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
| Study group | Role | What they receive |
|---|---|---|
| Positive Psychology + Motivational Interviewing | Experimental | Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Receives: Behavioral: Positive Psychology + Motivational Interviewing |
| Diabetes Education | Active comparator | Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). Receives: Behavioral: Diabetes Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of PP-MI Sessions Completed by Participants
Measured by number of PP-MI sessions completed by participants in the PP-MI group.
Measured: 16 weeks
Secondary outcomes (15)
Ease of PP Component
Participants in the PP-MI group will provide ratings of ease after each PP exercise, measured on a 10-point Likert scale (0=very difficult; 10=very easy). Weekly ratings were averaged to provide an overall ease of the exercises.
Measured: Weeks 1-16
Ease of MI Component
Participants in the PP-MI group will provide ratings of ease after each MI exercise, measured on a 10-point Likert scale (0=very difficult; 10=very easy). Weekly ratings were averaged to provide an overall ease of the exercises.
Measured: Weeks 1-16
Utility of PP Component
Participants in the PP-MI group will provide ratings of utility after each PP exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful). Weekly utility ratings were averaged to provide an overall utility score of the exercises.
Measured: Weeks 1-16
Utility of MI Component
Participants in the PP-MI group will provide ratings of utility after each MI exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful). Weekly utility ratings were averaged to provide an overall utility score of the exercises.
Measured: Weeks 1-16
Change in Moderate-Vigorous Physical Activity
ActiGraph GT3X+ step counters are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer for one week at baseline, 16 weeks, and 24 weeks to assess the feasibility of doing so and to ensure adequate capture of physical activity.
Measured: Change from Baseline to 16 weeks, and Baseline to 24 weeks
Change in Physical Activity
Measured by Actigraph accelerometer, in number of steps per day.
Measured: Change from Baseline to 16 weeks, and Baseline to 24 weeks
Change in Sedentary Time
Measured by Actigraph accelerometer, in minutes per day.
Measured: Change from Baseline to 16 weeks, and Baseline to 24 weeks
Change in Positive Affect
The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect (Range: 10-50). Change was calculated by subtracting the score at baseline from the score at 16 and 24 weeks. Higher scores indicate higher levels of positive affect.
Measured: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Change in Optimism
Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Change was calculated by subtracting the score at baseline from the score at 16 and 24 weeks. Higher scores indicate higher levels of optimism.
Measured: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Change in Self-Efficacy for Exercise
Measured by the Self-Efficacy for Exercise scale (SEE), a validated scale which assess self-efficacy barriers to exercise (Range: 0-90). Higher scores indicate higher efficacy expectations in relation to exercising. This was measured at Baseline, Week 16, and Week 24.
Measured: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Change in Depression
The Hospital Anxiety and Depression Scale (HADS)-depression subscale was be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 16 and 24 weeks. Higher scores indicate higher levels of depression.
Measured: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Change in Anxiety
The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale was be used to measure anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 16 and 24 weeks. Higher scores indicate higher levels of anxiety.
Measured: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Change in Resilience
Measured by the Brief Resilience Scale (BRS), a reliable scale which assesses a person's ability to recover from stress despite adversity (Range: 6-30). Higher scores indicate more resilience.
Measured: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Change in Perceived Social Support
Measured by the Multidimensional Scale of Perceived Social Support (MSPSS), a scale that measures subjectively reported social support (Range: 12-84). Higher scores indicate more subjectively reported social support.
Measured: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Change in Diabetes Self-Care
Measured by the Summary of Diabetes Self-Care Activities (SDSCA), a well-validated measure of diabetes self-management that is associated with clinical outcomes (Range: 0-7). Higher scores indicate more diabetes self-care activities.
Measured: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start25 Jul 2017
- Primary completion10 Oct 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeff C. Huffman, MD, Massachusetts General Hospital
- Investigators
- Jeff C Huffman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164538
- Sponsor's protocol ID
- 2017P001113
- Acronym
- BEHOLD-16
- Status last verified
- Feb 2021
- First submitted
- 22 May 2017
- Last updated
- 21 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Psychological-behavioral Intervention to Increase Activity in Type 2 Diabetes: a 16-week Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03164538
- Acronym / sponsor ID
- BEHOLD-16 / 2017P001113
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 23 May 2017 (actual)
- Results
- Posted 21 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The focus of this study is to examine the feasibility, acceptability, and impact of a customized, combined positive psychology and motivational interviewing (PP-MI) health behavior intervention in a group of patients with type 2 diabetes (T2D).
Detailed description
The investigators will compare a combined positive psychology and motivational interviewing (PP-MI) intervention that is adapted for patients with T2D to a diabetes education intervention (control) in a randomized controlled trial. The investigators will enroll 70 participants, who will be randomized to either a 16-week PP-MI health behavior intervention or an 16-week diabetes education intervention.
In this project, the investigators plan to do the following:
- Examine the feasibility and acceptability of a 16-week, telephone-delivered health behavior intervention utilizing PP exercises and MI with systematic goal-setting.
- Determine whether the PP-MI intervention leads to greater increases in physical activity than the education intervention in T2D patients.
- Explore the impact of the PP-MI intervention on other psychological, behavioral, and medical outcomes, compared to the education intervention.
Participants will undergo an initial screening visit during which they will meet with study staff in person. At this visit, study eligibility will be confirmed, and eligible and willing participants will be enrolled. Following enrollment, participants will complete self-report measures, and vital signs and A1c will be measured. They then will take home and wear an accelerometer for one week, to measure baseline physical activity.
Baseline information about enrolled participants will be obtained from the participants, care providers, and the electronic medical record as required for characterization of the population. This information will include data regarding medical history (type 2 diabetes mellitus), current medical variables (conditions affecting physical activity), medications, and sociodemographic data (age, gender, race/ethnicity, living alone).
Participants will undergo a second in-person visit once adequate baseline physical activity data has been obtained. In this visit, accelerometer data will be reviewed to ensure that adequate baseline activity was captured. If so, participants will be randomized to either the PP-MI or diabetes education condition, then begin the study intervention. During this second in-person visit, participants will receive either a PP-MI or diabetes education treatment manual, depending on randomization.
For the PP-MI intervention:
For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. At subsequent sessions, participants will review the prior week's PP exercise and learn about a new exercise, then will review the prior week's physical activity goal and set a new one.
For the diabetes education intervention:
Each week, participants will learn about a different health behavior topic related to diabetes health. This includes information about diabetes self-monitoring, medication adherence, having a heart-healthy diet, and being physically active.
Participants will complete the remaining sessions by phone approximately weekly over the next 16 weeks. Phone sessions will last approximately 30 minutes, with PP-MI and physical activity assignments completed between phone sessions. PP and MI will be delivered step-wise within sessions (rather than intertwined) based on our experience, participant feedback, and pilot work. If a week is missed, the session will not be skipped, but rather the intervention will be completed sequentially (with participants who miss weeks then missing the final sessions), with the exception of the final visit, which skips to Planning for the Future in all cases.
Participants will undergo an in-person follow-up assessment at 16 weeks. At this session, participants will repeat self-report assessments that were administered at baseline. Vital signs and a blood sample will again be collected at this in-person visit. Prior to this assessment, participants will wear an accelerometer for 7 days to measure physical activity. Participants will also undergo a phone follow-up assessment at 24 weeks. During this session over the phone, participants will repeat self-report assessments that were administered at baseline. Finally, prior to this follow-up, participants will wear another accelerometer for 7 days to measure physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Psychology + Motivational Interviewing | Experimental | Behavioral: Positive Psychology + Motivational InterviewingParticipants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. |
| Diabetes Education | Active comparator | Behavioral: Diabetes EducationParticipants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- T2D. Eligible patients will meet American Diabetes Association (ADA) criteria for T2D (e.g., HbA1c [A1C] ≥6.5%, fasting glucose ≥126 mg/d), with diagnosis confirmed by their diabetes clinician and/or medical record review.
- Low physical activity. Low physical activity will be defined as ≤150 minutes/week of MVPA (corresponding to ADA recommendations for moderate or greater intensity aerobic physical activity). Physical activity will be measured using a brief questionnaire adapted from the International Physical Activity Questionnaire (IPAQ).
Key exclusion criteria (5 listed)
- Cognitive impairment precluding consent or meaningful participation.
- Lack of phone availability.
- Inability to read/write in English.
- Additional medical conditions (e.g., severe arthritis) that preclude physical activity.
- Enrollment in mind-body programs, lifestyle intervention programs (e.g., cardiac rehabilitation), or other clinical trials.
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 |
|---|---|---|
| Positive Psychology + Motivational InterviewingParticipants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions. PP and MI components will be delivered stepwise within sessions (rather than intertwined). | Behavioural | Positive Psychology + Motivational Interviewing |
| Diabetes EducationEach week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments. | Behavioural | Diabetes Education |
Primary outcome
Number of PP-MI Sessions Completed by Participants
Time frame: 16 weeks
Measured by number of PP-MI sessions completed by participants in the PP-MI group.
15 secondary outcomes
Ease of PP Component
Time frame: Weeks 1-16
Ease of MI Component
Time frame: Weeks 1-16
Utility of PP Component
Time frame: Weeks 1-16
Utility of MI Component
Time frame: Weeks 1-16
Change in Moderate-Vigorous Physical Activity
Time frame: Change from Baseline to 16 weeks, and Baseline to 24 weeks
Change in Physical Activity
Time frame: Change from Baseline to 16 weeks, and Baseline to 24 weeks
Change in Sedentary Time
Time frame: Change from Baseline to 16 weeks, and Baseline to 24 weeks
Change in Positive Affect
Time frame: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Change in Optimism
Time frame: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Change in Self-Efficacy for Exercise
Time frame: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Change in Depression
Time frame: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Change in Anxiety
Time frame: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Change in Resilience
Time frame: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Change in Perceived Social Support
Time frame: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Change in Diabetes Self-Care
Time frame: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jeff C Huffman, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Psychology + Motivational Interviewing and Diabetes Education in people with Type 2 Diabetes Mellitus, run by Massachusetts General Hospital at 1 site in United States.
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 2 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 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 21 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of PP-MI Sessions Completed by Participants (time frame: 16 weeks). 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 21 Feb 2021; AzTrials last refreshed its copy on 31 Oct 2026.