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Completed

NCT Number: NCT05149417

Effect of Telemedecine on Post -Trauma Pain Medication Adherence .

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

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Key information

Conditions

Post-traumatic Pain

Age range

16 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fattouma Bourguiba Monastir University Hospital Center, Monastir, Tunisia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SMS reminding

Other

patients received SMS at day 2 , day 4 and day 7 after emergency departement discharge to remind them to take their treatment .

Telemonitoring

Other

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 outcomes

  1. Visual analog scale after 7 days of follow-up

    Time frame: 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 outcomes

  1. Likert scale

    Time frame: at seven day post ED discharge .

    Patients' satisfaction which was assessed through likert scale. minimum=1(strongly disagree) , maximum=5 (strongly agree)

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 8, 2021
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.