Text Message Study

NCT ID: NCT01789697

Last Updated: 2018-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-03-31

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.

Detailed Description

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Conditions

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Anxiety Pain Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Receives text messages/emails

Will receive text messages and emails periodically from the surgeon from Day 1 (day after discharge) through day 21.

Group Type EXPERIMENTAL

cellular device/computers

Intervention Type OTHER

A random group of patients will receive text messages to their cellular device from the surgeon, as well as emails to their email addresses.

Does not receive text messages/emails

Will not receive text messages and emails periodically from the surgeon from Day 1 (day after discharge) through day 21.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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cellular device/computers

A random group of patients will receive text messages to their cellular device from the surgeon, as well as emails to their email addresses.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00034182

Identifier Type: -

Identifier Source: org_study_id

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