Effect of Telemedecine on Post -Trauma Pain Medication Adherence .

Not Applicable

Completed

• Conditions: Post-traumatic Pain
• Interventions: Other: SMS reminding; Other: telemonitoring

• Registration Number: NCT05149417
• Lead Sponsor: University of Monastir

Brief Summary

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

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 Timeline

• Study Start: 2020-08-21
• Study First Submitted: 2021-11-18
• Study First Submitted QC: 2021-11-24
• Study First Posted: 2021-12-08
• Primary Completion: 2022-05-21
• Study Completion: 2022-07-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1350

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SMS group	SMS reminding	patients received SMS at day 2 , day 4 and day 7 after emergency departement discharge to remind them to take their treatment .
Standard group	telemonitoring	Patients enrolled in this group were discharged and they didn't undergo any intervention within the treatment period.
telemonitoring group	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.

Primary Outcome Measures

Name	Time	Method
Visual analog scale after 7 days of follow-up	at seven day after ED discharge .	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Fattouma Bourguiba University Hospital of Monastir; 🇹🇳 Monastir, Tunisia

Fattouma Bourguiba Monastir University Hospital Center; 🇹🇳 Monastir, Tunisia