NCT02610894

Brief 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, 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 9, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2016

Completed
Last Updated

October 22, 2018

Status Verified

October 1, 2018

Enrollment Period

10 months

First QC Date

November 9, 2015

Last Update Submit

October 18, 2018

Conditions

Orthopaedic Surgery

Keywords

postoperative symptom managementsymptom managementmHealth application

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

  • Change in perceived self efficacy

    baseline, day 1, day 5, day 14, day 28

  • Change in quality of life

    baseline, day 1, day 5, day 14, day 28

  • Change in postoperative heath status

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

  • Change in postoperative health status

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

  • Healthcare resource use

    28 days

Study Arms (2)

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.

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.

Other: As usual standard discharge and care instructions

Interventions

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

mHealth application
As usual standard discharge and care instructionsOTHER

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

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky Orthopaedic Surgery and Sports Medicine Clinic

Lexington, Kentucky, 40536, United States

Location

Study Officials

  • Jan Odom Forren, PhD, RN

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 9, 2015

First Posted

November 20, 2015

Study Start

October 7, 2015

Primary Completion

July 25, 2016

Study Completion

July 25, 2016

Last Updated

October 22, 2018

Record last verified: 2018-10

Locations

US(1)