Text Message Study

Not Applicable

Terminated

• Conditions: Pain; Surgical Site Infection; Anxiety
• Interventions: Other: cellular device/computers

• Registration Number: NCT01789697
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-02-08
• Study First Submitted QC: 2013-02-08
• Study First Posted: 2013-02-12
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-06
• Last Update Posted: 2018-04-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Receives text messages/emails	cellular device/computers	Will receive text messages and emails periodically from the surgeon from Day 1 (day after discharge) through day 21.

Primary Outcome Measures

Name	Time	Method
Change in Anxiety	Day 1-21, Month 3, Month 12	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 Surgical Site	Day 1-21	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.
Change in Pain	Day 1-21, Month 3, Month 12	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.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States