Effect of Telemedecine on Post -Trauma Pain Medication Adherence .

Effect of Telemedecine on Post-trauma Pain Medication Adherence After Discharge From Emergency Departement

The impact of telemonitoring on patients' adherence to post trauma pain treatment , their satisfaction and pain relief after discharge from the ED.

Study Overview

• Status: Completed
• Conditions: Post-traumatic Pain
• Intervention / Treatment: Other: telemonitoring; Other: SMS reminding

Detailed Description

This is a prospective, multicenter, randomized trial . Participants are recruited from the emergency departement of Fattouma Bourguiba Monastir.

This study is a seven day three-arm parallel group trial . Participants inculded are aged more than 16 years old who presented to the ED for minor trauma and discharged with analgesic treatment. They are randomized to one of two trial TM intervention groups (SMS and TM) or usual care group (control) in a 1 :1 :1 allocation ratio.

For all inculded patients, demographic characteristics were collected as well as clinical examination findings. The interventional care provided at the ED was mentioned. At ED discharge the pain Visual Analogue Scale (VAS) was evaluated and the analgesic treatment prescribed was noted.

• Study Type: Interventional
• Enrollment (Actual): 1350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Monastir, Tunisia, 5000
    • Fattouma Bourguiba Monastir University Hospital Center
  • Monastir, Tunisia, 5000
    • Fattouma bourguiba university hospital of Monastir

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age >16 years old with minor trauma and discharged with an analgesic treatment.
• Included patients should have regular access to a mobile phone ,were able to interact with SMS or could do so with help of a relative.
• Patients who accepted to participate to the study.
• No contraindication to analgesic medication

Exclusion Criteria:

• Swallowing disorder or inability to swallow.
• Unsuitable for follow-up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Standard group; Patients enrolled in this group were discharged and they didn't undergo any intervention within the treatment period.	Other: telemonitoring; Patients received a phone call on day 2 and day 4 to evaluate the adherence , to detect any problem that can affect the adherence to the treatment and modify the analgesic protocol treatment if needed.
Active Comparator: SMS group; patients received SMS at day 2 , day 4 and day 7 after emergency departement discharge to remind them to take their treatment .	Other: SMS reminding; patients received SMS at day 2 , day 4 and day 7 after emergency departement discharge to remind them to take their treatment .
Active Comparator: telemonitoring group; Patients received a phone call on day 2 and day 4 to evaluate the adherence , to detect any problem that can affect the adherence to the treatment and modify the analgesic protocol treatment if needed.	Other: telemonitoring; Patients received a phone call on day 2 and day 4 to evaluate the adherence , to detect any problem that can affect the adherence to the treatment and modify the analgesic protocol treatment if needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog scale after 7 days of follow-up	Patient's adherence to analgesics treatment which was assessed by calling patients or by sending SMS in day 2, day 4,and day 7 in SMS group and the telemonitoring group respectively.	at seven day after ED discharge .

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Likert scale	Patients' satisfaction which was assessed through likert scale. minimum=1(strongly disagree) , maximum=5 (strongly agree)	at seven day post ED discharge .

Collaborators and Investigators

• Sponsor: University of Monastir

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2020
• Primary Completion (Actual): May 21, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: November 18, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Adherence; Telemedecine; post- traumatic pain
• Other Study ID Numbers: Telemedecine /Adherence

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No