NCT01324427

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

August 14, 2020

Status Verified

August 1, 2020

Enrollment Period

9.4 years

First QC Date

March 24, 2011

Last Update Submit

August 12, 2020

Conditions

Keywords

TelemedicineVirtual Medical VisitQuality of Life11-022

Outcome Measures

Primary Outcomes (1)

  • 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

    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. \[Question #19: How would you rate the quality of the Telehealth visit to assess the patient compared to an in-person office visit?\]

    2 years

Secondary Outcomes (3)

  • Confirm that current telemedicine technology a comprehensive stem cell transplant clinical evaluation can be performed.

    2 years

  • Evaluate the feasibility of telemedicine facilitated "handoffs" between the inpatient and the outpatient service at the time of discharge from the inpatient service and at the time of discharge from the transplant center are feasible and useful.

    2 years

  • Describe the logistic characteristics of a "virtual medical visit" performed using telemedicine such as visit times, connection quality, and quality of the clinical information obtained.

    2 years

Study Arms (1)

virtual medical visit

EXPERIMENTAL

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.

Behavioral: virtual medical visit

Interventions

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."

virtual medical visit

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who underwent or are planning to undergo a hematopoietic progenitor cell transplantation for any disease.
  • Participants must be able to read and understand English\*
  • Age over 18 years of age since this pilot trial is only being performed in the Adult BMT Service Non-English speaking patients have been excluded in this pilot study because we do not have the support for translation services at this time. Additionally, the telemedicine instruments being used are not yet validated across all languages.
  • 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:
  • minimal comorbidities,
  • be less than 75 years of age. These characteristics have been associated with good understanding and acceptance of telemedicine in other pilot trials. These characteristics will be assessed by the clinician.
  • Please note: Patients on other therapeutic protocols will be eligible for this protocol as well.

You may not qualify if:

  • Medically unstable patient as deemed by the treating team.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Memoral Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Location

Memorial Sloan-Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center

Sleepy Hollow, New York, 10591, United States

Location

Related Links

Study Officials

  • Sergio Giralt, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2011

First Posted

March 29, 2011

Study Start

March 1, 2011

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

August 14, 2020

Record last verified: 2020-08

Locations