Text Message Study
Primary Purpose
Anxiety, Pain, Surgical Site Infection
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cellular device/computers
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety
Eligibility Criteria
Inclusion Criteria:
- Patients age greater than 18 years
- Patients who confirm they have an unlimited text message data plan and email capabilities on their mobile device
- Patients of Dr. Gottfried's underwent lumbar decompression or fusion surgery
- Patients with text message capabilities
- Patients who have an active email account
Exclusion Criteria:
- Patients who demonstrate an inability to fill out the pre-visit questionnaires
- Patients with a diagnosis of metastatic disease
- Patients with workers compensation or liability pending
- Patients who will require transfer to an acute rehabilitation facility following surgery
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Receives text messages/emails
Does not receive text messages/emails
Arm Description
Will receive text messages and emails periodically from the surgeon from Day 1 (day after discharge) through day 21.
Will not receive text messages and emails periodically from the surgeon from Day 1 (day after discharge) through day 21.
Outcomes
Primary Outcome Measures
Change in Anxiety
Anxiety is measured by the Zung Self-Rating Anxiety Scale, which will be filled out everyday from day 1 (day after discharge) through day 21, and at the 3 month and 12 month mark.
Change in Pain
Pain is measured by the VAS Scale, which will be filled out everyday from day 1 (day after discharge) through day 21, and at the 3 month and 12 month mark.
Change in Surgical Site
Changes in the surgical site is measured by a questionnaire, which will be filled out everyday from day 1 (day after discharge) through day 21.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01789697
Brief Title
Text Message Study
Official Title
Using Mobile Phone Text Messaging and E-mailing to Decrease Anxiety, Pain, Follow-up Visits and Improve Reporting of Surgical Site Infection After Spine Surgery: A Double-Blind Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Not sufficient staff to complete the trial.
Study Start Date
September 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objectives of this double-blind, randomized, controlled study are to evaluate the efficacy of maintaining contact with low-back pain patients through text messaging and emailing, to decrease anxiety levels, pain, number of follow-up visits through text messaging and emailing, and to improve reporting of surgical site infection after spine surgery through text messaging and emailing. The outcomes that will be measured are anxiety, pain, follow-up visits and received phone calls, and reporting signs of surgical site infection. Participants will include Dr. Oren Gottfried's patients who underwent spine surgery at Duke Hospital or at Duke Raleigh Hospital. Patients will be approached after determination that the patient is going to undergo spinal surgery. All patients meeting inclusion criteria will be approached to participate irrespective of race or ethnicity. A total of 194 subjects will be recruited.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Pain, Surgical Site Infection
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Receives text messages/emails
Arm Type
Experimental
Arm Description
Will receive text messages and emails periodically from the surgeon from Day 1 (day after discharge) through day 21.
Arm Title
Does not receive text messages/emails
Arm Type
No Intervention
Arm Description
Will not receive text messages and emails periodically from the surgeon from Day 1 (day after discharge) through day 21.
Intervention Type
Other
Intervention Name(s)
cellular device/computers
Intervention Description
A random group of patients will receive text messages to their cellular device from the surgeon, as well as emails to their email addresses.
Primary Outcome Measure Information:
Title
Change in Anxiety
Description
Anxiety is measured by the Zung Self-Rating Anxiety Scale, which will be filled out everyday from day 1 (day after discharge) through day 21, and at the 3 month and 12 month mark.
Time Frame
Day 1-21, Month 3, Month 12
Title
Change in Pain
Description
Pain is measured by the VAS Scale, which will be filled out everyday from day 1 (day after discharge) through day 21, and at the 3 month and 12 month mark.
Time Frame
Day 1-21, Month 3, Month 12
Title
Change in Surgical Site
Description
Changes in the surgical site is measured by a questionnaire, which will be filled out everyday from day 1 (day after discharge) through day 21.
Time Frame
Day 1-21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients age greater than 18 years
Patients who confirm they have an unlimited text message data plan and email capabilities on their mobile device
Patients of Dr. Gottfried's underwent lumbar decompression or fusion surgery
Patients with text message capabilities
Patients who have an active email account
Exclusion Criteria:
Patients who demonstrate an inability to fill out the pre-visit questionnaires
Patients with a diagnosis of metastatic disease
Patients with workers compensation or liability pending
Patients who will require transfer to an acute rehabilitation facility following surgery
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
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Text Message Study
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