Telemedicine Evaluation for Stem Cell Transplant Patients
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| First Received Date ICMJE | March 24, 2011 | ||||||||
| Last Updated Date | April 29, 2013 | ||||||||
| Start Date ICMJE | March 2011 | ||||||||
| Estimated Primary Completion Date | March 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Determine patient & physician acceptance of a "virtual medical visit" as a substitute for a "face to face" in pts in different settings. This is assessed by analyzing answers to questions 7 & 8 of the Patient Satisfaction Survey. [Question #7: I would [ Time Frame: 2 years ] [ Designated as safety issue: No ] Question #8: Overall, I was very satisfied with today's telemedicine session.]Physician acceptance will be analyzed looking at the answers to question 19 of the Physician/Nurse survey in which the physician or nurse investigator relates the quality of the telemedicine visit. [Question #19: How would you rate the quality of the Telehealth visit to assess the patient compared to an in-person office visit?] |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01324427 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Telemedicine Evaluation for Stem Cell Transplant Patients | ||||||||
| Official Title ICMJE | Pilot Trial of Telemedicine Evaluation for Stem Cell Transplant Patients | ||||||||
| Brief Summary | Telemedicine is a new area of health care where medical information is transferred through audiovisual media, such as a computer or a video camera, for the purpose of remote doctor's visits or examinations. This new area of health care is important to test because it can potentially provide real-time interactions between the patient and their health care team, including phone conversations, online communication, and/or home visits. Many activities such as a history review or physical examination can be conducted virtually as compared to the traditional face-to face visits. The purpose of this study is to determine patient and health care team acceptance of a "virtual medical visit" as a substitute for a "face to face" visit for patients either preparing to receive a stem cell transplant or previously received a stem cell transplant. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Stem Cell Transplant Patients | ||||||||
| Intervention ICMJE | Behavioral: virtual medical visit
At the pre-set time, the "Mobile Telehealth Cart" will be set up in the exam room or the clinic office, and a connection with the doctor will be made through their computer. The telemedicine visit will be conducted at the same time as the regular clinic visit. During the visit, the nurse will evaluate the physical symptoms, vital signs, past medical history, present medical history, and any side effects from the autologous or allogeneic transplant. The nurse will place a digital stethoscope on the chest to listen to the heart and lungs. The "virtual medical visit" will take about 25 minutes. At the end of the "Virtual Medical Visit," the patient will evaluate the event using a survey to assess the acceptance of the virtual visit. The surveys will be written and should take around 15 minutes to complete. The answers provided will be shared with the MD and nurses after the patient has completed all their "virtual medical visits." |
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| Study Arm (s) | Experimental: virtual medical visit
This is a pilot trial involving a maximum of 84 patients undergoing either allogeneic or autologous stem cell transplant aimed at determining the feasibility and acceptance of a "virtual medical visit" by patients and health care personnel. During this pilot trial we expect to perform 84 "virtual medical visits" using telemedicine.
Intervention: Behavioral: virtual medical visit |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 84 | ||||||||
| Estimated Completion Date | March 2014 | ||||||||
| Estimated Primary Completion Date | March 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Potential patients will be identified according to their medical condition, type and complexity of stem cell transplant procedure performed, and distance from MSKCC. The patients should:
Please note: Patients on other therapeutic protocols will be eligible for this protocol as well. Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 74 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01324427 | ||||||||
| Other Study ID Numbers ICMJE | 11-022 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Memorial Sloan-Kettering Cancer Center | ||||||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Memorial Sloan-Kettering Cancer Center | ||||||||
| Verification Date | April 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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