Effect of Telemedecine on Post -Trauma Pain Medication Adherence .

University of Monastir

Status: Completed

Conditions: Post-traumatic Pain

Treatments: Other: telemonitoring; Other: SMS reminding

Study type: Interventional

Funder types: Other

Identifiers

NCT05149417

Telemedecine /Adherence

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,350 patients

Sex: All

Ages: 16 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,350 participants in 3 patient groups, including a placebo group

Standard group

Placebo Comparator group

Description:

Patients enrolled in this group were discharged and they didn't undergo any intervention within the treatment period.

Treatment:

Other: telemonitoring

SMS group

Active Comparator group

Description:

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

Treatment:

Other: SMS reminding

telemonitoring group

Active Comparator group

Description:

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.

Treatment:

Other: telemonitoring