- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01283633
Investigation of the Use of Remote Presence Robots in Delivery of Neuromodulation
Investigation of the Use of Remote Presence Robots in the Administration of Neuromodulation Treatment
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Patients with neuromodulation systems implanted for either movement disorders or chronic pain and who require programming of their systems will be approached to enter the study. Those who consent will be consecutively assigned to either the normal standard of care (i.e. programming of their systems with an experienced clinician) or programming of their systems with an inexperienced programmer (nurse) who will be directed by the experienced programmer via the remote presence robot. Both the nurses and the patients will complete questionnaires rating their satisfaction of the programming experience.
They will each only receive one questionnaire at the end of the programming session. There is no other test point.
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H 1V7
- Centre for Clinical Research, Queen Elizabeth II Health Sciences Centre
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- patients with neuromodulation systems, requiring programming
- nurses who have never programmed a neuromodulation system before
Exclusion Criteria:
- those who are unwilling to give consent
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: programming with non-experienced nurse
Programming done by an experienced neuromodulation clinician will be compared to the patient satisfaction of a programming session with an inexperienced nurse via remote presence robotics, which will be directed by the experienced clinician
|
Neuromodulation as directed via remote presence robotic and experienced clinician for those with neuromodulation systems implanted to treat movement disorders and chronic pain
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient Satisfaction
Tidsramme: Patients will complete the questionnaire once following the neuromodulation therapy. Day 1
|
The questionnaire will take approximately 10 minutes to complete.
There are no other follow-ups required.
This is the only study time commitment for the patients above the usual standard of care.
|
Patients will complete the questionnaire once following the neuromodulation therapy. Day 1
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Nursing satisfaction questionnaire
Tidsramme: Immediately following the neuromodulation session, the nurse will complete one questionnnaire. Day 1.
|
The questionnaire will take approximately 10 minutes to complete.
The time commitment from the nurse programmer will be approximately 45 minutes.
There are no other test points nor follow up visits.
|
Immediately following the neuromodulation session, the nurse will complete one questionnnaire. Day 1.
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Ivar M Mendez, MD, Capital Health and Dalhousie University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- Robotics-Neuromod-Mendez
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