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.
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
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.
- Conditions
- Orthopaedic Surgery
- 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 group | Role | What they receive |
|---|---|---|
| mHealth application | Experimental | Participants 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 Group | Active comparator | Participants 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.
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)
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
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
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.
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.
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.
- First posted20 Nov 2015 (estimated)
- Study start7 Oct 2015
- Primary completion25 Jul 2016
- Study completion25 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopaedic SurgeryStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jan Odom Forren
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jan Odom Forren, University of Kentucky
- Investigators
- Jan Odom Forren, PhD, RN, Principal investigator, University of Kentucky
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A mHealth Self-Management Program to Decrease Postoperative Symptom Distress in Orthopaedic Patients
- ClinicalTrials.gov ID
- NCT02610894
- Acronym / sponsor ID
- 15-0340-P6H
- Conditions
- Orthopaedic Surgery
- Keywords
- postoperative symptom management, symptom management, mHealth application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Jan Odom ForrenUniversity, hospital or other
- Study start
- 7 Oct 2015 (actual)
- Primary completion
- 25 Jul 2016 (actual)
- Study completion
- 25 Jul 2016 (actual)
- First posted
- 20 Nov 2015 (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 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mHealth application | Experimental | Other: mHealth application (PoCAH)Participants 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. |
| Control Group | Active comparator | Other: As usual standard discharge and care instructionsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
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 |
|---|---|---|
| mHealth application (PoCAH)Participants will have unlimited access to the mHealth app via iPad Mini for 5 days post-operatively to aid in pain management | Other | mHealth application |
| As usual standard discharge and care instructionsAs usual standard discharge and care instructions are provided via iPad mini to orthopaedic ambulatory surgery patients. | Other | Control Group |
Primary outcome
Change in perceived pain
Time frame: baseline, day 1, day 2, day 3, day 4, day 5, day 14, day 28
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.
5 secondary outcomes
Change in perceived self efficacy
Time frame: baseline, day 1, day 5, day 14, day 28
Change in quality of life
Time frame: baseline, day 1, day 5, day 14, day 28
Change in postoperative heath status
Time frame: preoperative assessment, Day 1, Day 5, day 14,and day 28.
Change in postoperative health status
Time frame: preoperative assessment, Day 1, Day 5, day 14,and day 28.
Healthcare resource use
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 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.
Jan Odom Forren, PhD, RN principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
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.