Text Message Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Anxiety, Pain, Surgical Site Infection

Intervention / Treatment
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* Other: cellular device/computers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Receives text messages/emails<br>Will receive text messages and emails periodically from the surgeon from Day 1 (day after discharge) through day 21. | Other: cellular device/computers<br>* A random group of patients will receive text messages to their cellular device from the surgeon, as well as emails to their email addresses.<br>|
| No Intervention: Does not receive text messages/emails<br>Will not receive text messages and emails periodically from the surgeon from Day 1 (day after discharge) through day 21. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1-21, Month 3, Month 12 | 
| 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. | Day 1-21, Month 3, Month 12 | 
| 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. | Day 1-21 |