DIabetesRSMINCT00522327
Remote Simultaneous Medical Interpreting and Medical Outcomes
A study testing remote simultaneous medical interpreting, usual and customary and ENglish speaking in people with DIabetes, run by NYU Langone Health.
Trial summary
All new patients to the general medicine clinic who were not primarily English speaking were randomized, after consenting, to receieve either remote simultaneous medical interpreting or usual and customary interpreting services. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- DIabetes
- What is being tested?
- remote simultaneous medical interpreting, usual and customary and ENglish speaking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Nov 2004to Oct 2006
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Limited English-speaking
- English-speaking
- New patient in medicine clinic
Who cannot join
None listed.
About this study
Official title: Remote Simultaneous Medical Interpretation: Medical Outcomes
All new patients to the general medicine clinic who were not primarily English speaking were randomized, after consenting, to receieve either remote simultaneous medical interpreting or usual and customary interpreting services. Patient charts were followed for one year after enrollment to assess medical outcomes, including patient satisfaction, diabetes management, lipid management, depression screening and management, vaccine administration.
All Spanish-speaking ER patients were similarly enrolled. They were followed for one ER visit and their knowledge of exit instructions was assessed, as well as their satisfaction with care.
- Conditions
- DIabetes
- Being tested
- remote simultaneous medical interpreting, usual and customary, ENglish speaking
- Keywords
- Immigrant, Interpreting
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote simultaneous medical interpretingOther
remote simultaneous medical interpretation
usual and customaryOther
usual and customary interpreting
ENglish speakingOther
English speakers
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | remote simult med interpret Receives: Other: remote simultaneous medical interpreting |
| 2 | Active comparator | Usual \& Customary Receives: Other: usual and customary |
| 3 | Other | comparison group Receives: Other: ENglish speaking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence with care
Measured: one year
Secondary outcomes (1)
care parameters
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2007 (estimated)
- Study startNov 2004
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DIabetesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- The California Endowment, The Commonwealth Fund
- Investigators
- Francesca M Gany, MD., M.S., Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522327
- Sponsor's protocol ID
- Calendow/CMWF
- Acronym
- RSMI
- Status last verified
- Jul 2015
- First submitted
- 27 Aug 2007
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Leng JC, Changrani J, Gany FM. Language discordance and testing for latent tuberculosis infection among recent Asian and Latino immigrants. J Community Health. 2011 Apr;36(2):228-30. doi: 10.1007/s10900-010-9301-2.
PubMed 20697787Leng JC, Changrani J, Tseng CH, Gany F. Detection of depression with different interpreting methods among Chinese and Latino primary care patients: a randomized controlled trial. J Immigr Minor Health. 2010 Apr;12(2):234-41. doi: 10.1007/s10903-009-9254-7.
PubMed 19408119Gany F, Leng J, Shapiro E, Abramson D, Motola I, Shield DC, Changrani J. Patient satisfaction with different interpreting methods: a randomized controlled trial. J Gen Intern Med. 2007 Nov;22 Suppl 2(Suppl 2):312-8. doi: 10.1007/s11606-007-0360-8.
PubMed 17957417
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Simultaneous Medical Interpretation: Medical Outcomes
- ClinicalTrials.gov ID
- NCT00522327
- Acronym / sponsor ID
- RSMI / Calendow/CMWF
- Conditions
- DIabetes
- Keywords
- Immigrant, Interpreting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- The California Endowment, The Commonwealth Fund
- Study start
- Nov 2004
- Study completion
- Oct 2006 (actual)
- First posted
- 29 Aug 2007 (estimated)
- 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.
All new patients to the general medicine clinic who were not primarily English speaking were randomized, after consenting, to receieve either remote simultaneous medical interpreting or usual and customary interpreting services. Patient charts were followed for one year after enrollment to assess medical outcomes, including patient satisfaction, diabetes management, lipid management, depression screening and management, vaccine administration.
All Spanish-speaking ER patients were similarly enrolled. They were followed for one ER visit and their knowledge of exit instructions was assessed, as well as their satisfaction with care.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: remote simultaneous medical interpretingremote simult med interpret |
| 2 | Active comparator | Other: usual and customaryUsual \& Customary |
| 3 | Other | Other: ENglish speakingcomparison group |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Limited English-speaking
- English-speaking
- New patient in medicine clinic
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| remote simultaneous medical interpretingremote simultaneous medical interpretation | Other | 1 |
| usual and customaryusual and customary interpreting | Other | 2 |
| ENglish speakingEnglish speakers | Other | 3 |
Primary outcome
Adherence with care
Time frame: one year
1 secondary outcome
care parameters
Time frame: one year
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 7 Jul 2015.
- Derived from this study: PubMed 20697787Leng JC, Changrani J, Gany FM. Language discordance and testing for latent tuberculosis infection among recent Asian and Latino immigrants. J Community Health. 2011 Apr;36(2):228-30. doi: 10.1007/s10900-010-9301-2.
- Derived from this study: PubMed 19408119Leng JC, Changrani J, Tseng CH, Gany F. Detection of depression with different interpreting methods among Chinese and Latino primary care patients: a randomized controlled trial. J Immigr Minor Health. 2010 Apr;12(2):234-41. doi: 10.1007/s10903-009-9254-7.
- Derived from this study: PubMed 17957417Gany F, Leng J, Shapiro E, Abramson D, Motola I, Shield DC, Changrani J. Patient satisfaction with different interpreting methods: a randomized controlled trial. J Gen Intern Med. 2007 Nov;22 Suppl 2(Suppl 2):312-8. doi: 10.1007/s11606-007-0360-8.
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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.
Francesca M Gany, MD., M.S. principal investigator
NYU Langone Health
Questions about this trial
What is this clinical trial studying?
A study testing remote simultaneous medical interpreting, usual and customary and ENglish speaking in people with DIabetes, run by NYU Langone Health.
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 3 inclusion and 0 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 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Adherence with care (time frame: one year). 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 NCT00522327, which also lists 3 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 7 Jul 2015.