Post-traumatic PainNCT05149417
Effect of Telemedecine on Post -Trauma Pain Medication Adherence .
A study testing SMS reminding and telemonitoring in people with Post-traumatic Pain, run by University of Monastir at 2 sites in Tunisia.
Trial summary
The impact of telemonitoring on patients' adherence to post trauma pain treatment , their satisfaction and pain relief after discharge from the ED. Read more about this study
- Who is it for?
- Ages 16 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-traumatic Pain
- What is being tested?
- SMS reminding and telemonitoring
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,350 participants
- Where
- 2 sitesTunisia
- Study dates
- 21 Aug 2020to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Swallowing disorder or inability to swallow.
- Unsuitable for follow-up.
Trial locations and contacts
2 sites in 1 country.
Tunisia2 sites
Fattouma Bourguiba Monastir University Hospital Center
Monastir, 5000
Fattouma Bourguiba University Hospital of Monastir
Monastir, 5000
About this study
Official title: 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.
Read the 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.
- Conditions
- Post-traumatic Pain
- Being tested
- SMS reminding, telemonitoring
- Keywords
- Telemedecine, Adherence, post- traumatic pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS remindingOther
patients received SMS at day 2 , day 4 and day 7 after emergency departement discharge to remind them to take their treatment .
telemonitoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard group | Placebo comparator | Patients enrolled in this group were discharged and they didn't undergo any intervention within the treatment period. Receives: Other: telemonitoring |
| SMS group | Active comparator | patients received SMS at day 2 , day 4 and day 7 after emergency departement discharge to remind them to take their treatment . Receives: Other: SMS reminding |
| telemonitoring group | Active comparator | 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. Receives: Other: telemonitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at seven day after ED discharge .
Secondary outcomes (1)
Likert scale
Patients' satisfaction which was assessed through likert scale. minimum=1(strongly disagree) , maximum=5 (strongly agree)
Measured: at seven day post ED discharge .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start21 Aug 2020
- Primary completion21 May 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Included patients were randomized to one of the 3 groups: 1. Usual care (control) group Patients enrolled in this group were discharged and they didn't undergo any intervention within the treatment period. 2. SMS group Or short message service (SMS) group: patients received SMS at day 2 every day to remind them to take their treatment . 3. 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 according to an algorithm: At each call (day 2 and day 4), the VAS was assessed. If VAS ≥ 3 we looked for a medication discontinuation, inadequate dose or change of the prescribed treatment and the patient was instructed to take action accordingly . If the problem is related to side effects, the analgesic treatment was changed or associated to another analgesic
- Masking
- None (open label)
- Enrolment
- 1,350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149417
- Sponsor's protocol ID
- Telemedecine /Adherence
- Status last verified
- Aug 2022
- First submitted
- 18 Nov 2021
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Telemedecine on Post-trauma Pain Medication Adherence After Discharge From Emergency Departement
- ClinicalTrials.gov ID
- NCT05149417
- Acronym / sponsor ID
- Telemedecine /Adherence
- Conditions
- Post-traumatic Pain
- Keywords
- Telemedecine, Adherence, post- traumatic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,350 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 21 Aug 2020 (actual)
- Primary completion
- 21 May 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Included patients were randomized to one of the 3 groups: 1. Usual care (control) group Patients enrolled in this group were discharged and they didn't undergo any intervention within the treatment period. 2. SMS group Or short message service (SMS) group: patients received SMS at day 2 every day to remind them to take their treatment . 3. 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 according to an algorithm: At each call (day 2 and day 4), the VAS was assessed. If VAS ≥ 3 we looked for a medication discontinuation, inadequate dose or change of the prescribed treatment and the patient was instructed to take action accordingly . If the problem is related to side effects, the analgesic treatment was changed or associated to another analgesic
| Arm | Type | Receives |
|---|---|---|
| Standard group | Placebo comparator | Other: telemonitoringPatients enrolled in this group were discharged and they didn't undergo any intervention within the treatment period. |
| SMS group | Active comparator | Other: SMS remindingpatients received SMS at day 2 , day 4 and day 7 after emergency departement discharge to remind them to take their treatment . |
| telemonitoring group | Active comparator | Other: telemonitoringPatients 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. |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Swallowing disorder or inability to swallow.
- Unsuitable for follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS remindingpatients received SMS at day 2 , day 4 and day 7 after emergency departement discharge to remind them to take their treatment . | Other | SMS group |
| telemonitoringPatients 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 | Standard group, telemonitoring group |
Primary outcome
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.
1 secondary outcome
Likert scale
Time frame: at seven day post ED discharge .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS reminding and telemonitoring in people with Post-traumatic Pain, run by University of Monastir at 2 sites in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale after 7 days of follow-up (time frame: at seven day after ED discharge .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.