AnxietyNCT01789697
Text Message Study
A study testing cellular device/computers in people with Anxiety and Pain, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Pain, Surgical Site Infection
- What is being tested?
- cellular device/computers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this 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
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.
- Conditions
- Anxiety, Pain, Surgical Site Infection
- Being tested
- cellular device/computers
- Medical subject headings
- Anxiety Disorders, Pain, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cellular device/computersOther
A random group of patients will receive text messages to their cellular device from the surgeon, as well as emails to their email addresses.
| Study group | Role | What they receive |
|---|---|---|
| Receives text messages/emails | Experimental | Will receive text messages and emails periodically from the surgeon from Day 1 (day after discharge) through day 21. Receives: Other: cellular device/computers |
| Does not receive text messages/emails | No intervention | Will not receive text messages and emails periodically from the surgeon from Day 1 (day after discharge) through day 21. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 1-21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study startSep 2012
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Not sufficient staff to complete the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789697
- Sponsor's protocol ID
- Pro00034182
- Status last verified
- Apr 2018
- First submitted
- 8 Feb 2013
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01789697
- Acronym / sponsor ID
- Pro00034182
- Conditions
- Anxiety, Pain, Surgical Site Infection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not sufficient staff to complete the trial.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 12 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receives text messages/emails | Experimental | Other: cellular device/computersWill receive text messages and emails periodically from the surgeon from Day 1 (day after discharge) through day 21. |
| Does not receive text messages/emails | No intervention | –Will not receive text messages and emails periodically from the surgeon from Day 1 (day after discharge) through day 21. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cellular device/computersA random group of patients will receive text messages to their cellular device from the surgeon, as well as emails to their email addresses. | Other | Receives text messages/emails |
Primary outcome
Change in Anxiety
Time frame: 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 Pain
Time frame: 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.
Change in Surgical Site
Time frame: 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.
Results and safety
The study was stopped early (reason given: Not sufficient staff to complete the trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cellular device/computers in people with Anxiety and Pain, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not sufficient staff to complete the trial.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety (time frame: Day 1-21, Month 3, Month 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2018.