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Orthopaedic SurgeryNCT02610894

An mHealth Self-Management Program to Decrease Postoperative Symptom Distress

A study testing mHealth application (PoCAH) and As usual standard discharge and care instructions in people with Orthopaedic Surgery, run by Jan Odom Forren at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purposes of this study are to determine if use of the Postoperative Care at Home (PoCAH) tailored self-management program delivered via mobile technology (a mobile app) after discharge to home will result in: 1) fewer and/or less intense patient symptoms (pain, nausea and vomiting, fatigue, sore throat… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Orthopaedic Surgery
What is being tested?
mHealth application (PoCAH) and As usual standard discharge and care instructions
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
7 Oct 2015to 25 Jul 2016
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • individuals of either gender and any ethnicity;
  • general and regional anesthesia for a shoulder or knee procedure;
  • surgery scheduled at the UK Center for Advanced Surgery (CAS);
  • age greater than or equal to 18

Who cannot join

  • chronic pain or nausea unrelated to surgery;
  • inability to speak or read English;
  • diagnosed cognitive dysfunction;
  • disabilities that limit the capability to manipulate the mHealth device (iPad mini);
  • visual impairment;
  • unscheduled admission after surgery.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Kentucky Orthopaedic Surgery and Sports Medicine Clinic

    Lexington, Kentucky, 40536

Other trials in United States

About this study

Official title: A mHealth Self-Management Program to Decrease Postoperative Symptom Distress in Orthopaedic Patients

The purposes of this study are to determine if use of the Postoperative Care at Home (PoCAH) tailored self-management program delivered via mobile technology (a mobile app) after discharge to home will result in: 1) fewer and/or less intense patient symptoms (pain, nausea and vomiting, fatigue, sore throat, constipation, sleep dysfunction); 2) enhanced patient satisfaction, perceived self-efficacy, and quality of life; 3) lower healthcare resource use (patient to healthcare provider calls; unscheduled patient appointments with healthcare providers; and hospital readmission and emergency department use). A secondary objective is to assess how easy the mobile app was to use after orthopaedic ambulatory surgery.

Read the detailed description

The purposes of the single-blind randomized, controlled comparative effectiveness trial are to determine if use of the Postoperative Care at Home (PoCAH) tailored self-management program delivered via mobile technology after discharge to home will result in: 1) fewer and/or less intense patient symptoms (pain, nausea and vomiting, fatigue, sore throat, constipation, sleep dysfunction); 2) enhanced patient satisfaction, perceived self-efficacy, and quality of life; 3) lower healthcare resource use (patient to healthcare provider calls; unscheduled patient appointments with healthcare providers; and hospital readmission and emergency department use). A secondary objective is to assess the utility and effectiveness of the mHealth app after orthopaedic ambulatory surgery. This is a single-blind, two-group randomized, controlled comparative effectiveness trial stratified by knee and shoulder surgical procedures (N = 40; 20 per procedure, with half in each procedure group randomized to each treatment group) to compare the effectiveness of treatment as usual to treatment as usual combined with PoCAH. PoCAH is a theory based, patient-centered, and tailored self-management program delivered via mHealth technology to orthopaedic ambulatory surgery patients. Patients in the treatment as usual group will receive standard discharge and care instructions provided on an iPad mini. Patients in the intervention group (treatment as usual combined with PoCAH) will have access to the PoCAH app, in addition to the standard discharge and care instructions. The PoCAH app will provide the patient with additional information regarding self-management of symptoms and other consequences of surgery. Orthopaedic patients who undergo knee and shoulder ambulatory surgery will be recruited because these patients typically report more postoperative symptom distress than patients undergoing other surgical procedures. The sample will consist of 40 adults recruited from the University of Kentucky Orthopaedic Surgery and Sports Medicine Clinic in Lexington, Kentucky. After consent is obtained, all patients, regardless of grouping, will complete assessments (a Patient Diary) at enrollment (i.e., baseline), which will query/assess demographic information, health literacy, quality of life, quality of recovery and perceived self-efficacy of symptom management. Health literacy will be acquired preoperatively in the event literacy is a confounding factor in use of the app. These materials will be collected by the researcher at that time. During surgery, patients will undergo anesthesia as determined by the anesthesia provider and receive usual surgical care preoperatively and postoperatively. Medical chart data regarding the surgery will be abstracted and will include length of surgery, length of stay in the Post Anesthesia Care Unit (PACU), medications/anesthetics administered, and information regarding pain and nausea in the PACU and Phase 2 Recovery (Step-Down Unit). After surgery, data will be collected daily for 5 days from all participants (Day 1 through Day 5) via a Patient Diary. The Patient Diary will contain previously validated questionnaires that will assess Quality of Life, Quality of Recovery, and postoperative symptoms. The Patient Diary will be completed in the patients' homes while they recover. The investigators will call the patients at home on Day 2 to facilitate data collection. At the conclusion of the study (Day 5), participants in the intervention group will evaluate the utility and effectiveness of the PoCAH app. The iPad minis and Patient Diaries will be returned to the research staff when the patient attends the physician's office on the first office visit at 5 days post-surgery. Because the course of post discharge symptoms extends past 5 days, phone interviews at 2 weeks and 4 weeks are included to better describe the recovery trajectory and outcomes for operative patients.

Being tested
mHealth application (PoCAH), As usual standard discharge and care instructions
Keywords
postoperative symptom management, symptom management, mHealth application

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mHealth application (PoCAH)Other

    Participants will have unlimited access to the mHealth app via iPad Mini for 5 days post-operatively to aid in pain management

  • As usual standard discharge and care instructionsOther

    As usual standard discharge and care instructions are provided via iPad mini to orthopaedic ambulatory surgery patients.

Study groups in NCT02610894
Study groupRoleWhat they receive
mHealth applicationExperimentalParticipants will be provided an iPad Mini tablet computer loaded with an mHealth application (PoCAH) to provide enhanced post-operative pain care management. The app will utilize algorithms tailored to the patient's needs and symptoms in an attempt to reduce poor outcomes related to post-operative pain management.
Receives: Other: mHealth application (PoCAH)
Control GroupActive comparatorParticipants will be provided an iPad Mini tablet computer loaded with a PDF of the As usual standard discharge and care instructions for post-operative pain care management.
Receives: Other: As usual standard discharge and care instructions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in perceived pain

    Participants will be asked on multiple occasions (pre-operative assessment,day 1, day 2, day 3, day 4, day 5, day 14 and day 28) to rate their pain on a scale of 0-10. Zero would indicate no pain and 10 would represent the worst pain imaginable. Data will be presented as the change in perceived pain over the course of 28 days.

    Measured: baseline, day 1, day 2, day 3, day 4, day 5, day 14, day 28

Secondary outcomes (5)
  1. Change in perceived self efficacy

    Instrument specifically designed to measure perceived self-efficacy to manage postoperative symptoms and conditions of postoperative care. Participants will be asked a series of questions with scores ranging from 0-10 where 10 represents absolute self confidence in a task and 0 represents no confidence in a task. Data will be presented as the change in self-efficacy over the course of 28 days. Data will be collected at the following time points: preoperative assessment, Day 1, Day 5, day 14,and day 28.

    Measured: baseline, day 1, day 5, day 14, day 28

  2. Change in quality of life

    The European Quality of Life Survey includes questions addressing the following five categories: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Participants will be asked to answer the questions with the following five responses: no problems, slight problems, moderate problems, severe problems, and extreme. Answers are scored on a 1-5 scale and combined into a 5 digit number conveying the participants overall quality of life. Data will be presented as the change in quality of life over the course of 28 days. Data will be collected at the following time points: preoperative assessment, Day 1, Day 5, day 14,and day 28.

    Measured: baseline, day 1, day 5, day 14, day 28

  3. Change in postoperative heath status

    The Quality of Recovery Patient Survey (QoR-15) is a 15 question survey that measures early postoperative health status. Each question is answered on a scale of 0-10 were 10 is a very positive answer and zero is the worst possible scenario. Data will be presented as the change in postoperative health status over the course of 28 days. The assessment will take place preoperative assessment, Day 1, Day 5, day 14,and day 28.

    Measured: preoperative assessment, Day 1, Day 5, day 14,and day 28.

  4. Change in postoperative health status

    The Swedish Quality of Recovery Patient Survey (QoR-40) is a 40 question survey that measures early postoperative health status. Each question is answered on a scale of 0-10 were 10 is a very positive answer and zero is the worst possible scenario. Data will be presented as the change in postoperative health status over the course of 28 days. The assessment will take place preoperative assessment, Day 1, Day 5, day 14,and day 28.

    Measured: preoperative assessment, Day 1, Day 5, day 14,and day 28.

  5. Healthcare resource use

    Number of patient to healthcare provider calls, unscheduled patient appointment with healthcare providers, hospital readmissions, emergency department visits. Data will be collected through a medical record search and presented as the total count of healthcare resources used per group in 28 days.

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2015 (estimated)
  2. Study start7 Oct 2015
  3. Primary completion25 Jul 2016
  4. Study completion25 Jul 2016

Resources

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
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02610894
Sponsor's protocol ID
15-0340-P6H
Status last verified
Oct 2018
First submitted
9 Nov 2015
Last updated
22 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing mHealth application (PoCAH) and As usual standard discharge and care instructions in people with Orthopaedic Surgery, run by Jan Odom Forren 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 22 Oct 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 perceived pain (time frame: baseline, day 1, day 2, day 3, day 4, day 5, day 14, day 28). 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 22 Oct 2018.

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