Chronic PainNCT04370717
Chronic Pain Management During a Pandemic
An observational study of Chronic Pain, run by Unika Medical Centre at 1 site in Canada.
Trial summary
This is an open-label cohort study of chronic pain patients referred to an interdisciplinary community outpatient clinic. The aim of this study is to determine whether video consultations are non-inferior to regular consultations in diagnosing and planning subsequent interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- telehealth consultation
- How many people
- 49 participants
- Where
- 1 siteCanada
- Study dates
- 22 Apr 2020to 8 Apr 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Consecutive community patients referred to the interdisciplinary clinic
Who may be able to join
- all patients referred for consultation
Who cannot join
- Not English-speakers
- Patients who do not have any compatible telecommunication devices
- Patients illiterate in basic telecommunication and have no one in their household to help
- Patients unable to complete online self-assessment forms and study questionnaires
- Patients unable to make a follow-up visit
- Individuals with unstable pain complaints
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Pain Management During a Pandemic: Will Telemedicine Replace In-person Consultation
This is an open-label cohort study of chronic pain patients referred to an interdisciplinary community outpatient clinic. The aim of this study is to determine whether video consultations are non-inferior to regular consultations in diagnosing and planning subsequent interventions. The null hypothesis is that there is no difference in the International Statistical Classification of Diseases 10th edition (ICD-10) codes established via telehealth and subsequent clinic visits. The patients will complete standard health questionnaires online and undergo a structured and detailed interview to clarify the diagnosis and establish appropriate treatment. A limited telehealth physical examination based on direct observation will be conducted.
At the subsequent clinic visit, the accuracy of diagnosis and adherence to the plan of care will be evaluated.
The primary and secondary endpoints will be gathered from the electronic charts and from the recruited participants by questionnaires completed online one week after the telemedicine consultation. The diagnosis and plan of care semi-structured match will be performed during the in-person follow-up visit.
- Conditions
- Chronic Pain
- Being tested
- telehealth consultation
- Keywords
- chronic pain, telehealth
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telehealth consultationOther
Also called in-person visit
A telehealth consultation will be scheduled and conducted without modifications from the routine clinic protocol. The case report will include ICD-10 code and plan of care.
After one week, patients will receive an electronic satisfaction survey. An in-person follow-up and/or procedural visit will be subsequently scheduled. During this visit, the same physician will complete physical examination, document the diagnosis and proceed with either the same or modified plan of care. The research coordinator will enter diagnostic and procedural codes in the case report form.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with a matching diagnosis between telehealth and in-person consultation
Measured: 6 months
Secondary outcomes (4)
Percentage of patients with a matching plan of care/recommendations between telehealth and in-person visit
Measured: 6 months
Patient satisfaction from telehealth encountered measured on 7-point Likert scale
Measured: 6 months
feasibility of telehealth visits
(a) percentage of patients who accepted telemedicine as an equal substitute to in-person consultation. Participants will be asked the question with possible answers "Yes" or "No", "Why Yes?" "Why No?" (b) dropout rates and causes of dropouts (medical or technical reasons) will be registered (c) participants' satisfaction with video quality and sound quality (patients will be asked if they were "satisfied" with the video quality and sound quality after telemedicine consultation; "Yes" or "No", "Why not?"), (d) technical errors with the telemedicine equipment, and (e) specialist consultation time in minutes.
Measured: 6 months
cost-saving
Calculated cost-saving included (a) cost of travel in Canadian dollars, (b) estimated loss of income (<3.5 hours=a half day's salary, >3.5 hours spent on travel and consultation=one day's salary), (c) travelling distance in kilometres and travelling time in hours as estimated by Google Maps.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start22 Apr 2020
- Primary completion8 Apr 2021
- Study completion8 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unika Medical Centre
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Michael Gofeld, Unika Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370717
- Sponsor's protocol ID
- Telehealth_01
- Status last verified
- Apr 2021
- First submitted
- 25 Apr 2020
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Pain Management During a Pandemic: Will Telemedicine Replace In-person Consultation
- ClinicalTrials.gov ID
- NCT04370717
- Acronym / sponsor ID
- Telehealth_01
- Conditions
- Chronic Pain
- Keywords
- chronic pain, telehealth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Unika Medical CentreResearch network
- Study start
- 22 Apr 2020 (actual)
- Primary completion
- 8 Apr 2021 (actual)
- Study completion
- 8 Apr 2021 (actual)
- First posted
- 1 May 2020 (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.
This is an open-label cohort study of chronic pain patients referred to an interdisciplinary community outpatient clinic. The aim of this study is to determine whether video consultations are non-inferior to regular consultations in diagnosing and planning subsequent interventions. The null hypothesis is that there is no difference in the International Statistical Classification of Diseases 10th edition (ICD-10) codes established via telehealth and subsequent clinic visits. The patients will complete standard health questionnaires online and undergo a structured and detailed interview to clarify the diagnosis and establish appropriate treatment. A limited telehealth physical examination based on direct observation will be conducted.
At the subsequent clinic visit, the accuracy of diagnosis and adherence to the plan of care will be evaluated.
The primary and secondary endpoints will be gathered from the electronic charts and from the recruited participants by questionnaires completed online one week after the telemedicine consultation. The diagnosis and plan of care semi-structured match will be performed during the in-person follow-up visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive community patients referred to the interdisciplinary clinic
Key inclusion criteria (1 listed)
- all patients referred for consultation
Key exclusion criteria (6 listed)
- Not English-speakers
- Patients who do not have any compatible telecommunication devices
- Patients illiterate in basic telecommunication and have no one in their household to help
- Patients unable to complete online self-assessment forms and study questionnaires
- Patients unable to make a follow-up visit
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 |
|---|---|---|
| telehealth consultationAlso: in-person visitA telehealth consultation will be scheduled and conducted without modifications from the routine clinic protocol. The case report will include ICD-10 code and plan of care. After one week, patients will receive an electronic satisfaction survey. An in-person follow-up and/or procedural visit will be subsequently scheduled. During this visit, the same physician will complete physical examination, document the diagnosis and proceed with either the same or modified plan of care. The research coordinator will enter diagnostic and procedural codes in the case report form. | Other | – |
Primary outcome
Percentage of patients with a matching diagnosis between telehealth and in-person consultation
Time frame: 6 months
4 secondary outcomes
Percentage of patients with a matching plan of care/recommendations between telehealth and in-person visit
Time frame: 6 months
Patient satisfaction from telehealth encountered measured on 7-point Likert scale
Time frame: 6 months
feasibility of telehealth visits
Time frame: 6 months
cost-saving
Time frame: 6 months
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 21 Apr 2021.
- website of the participating clinicLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Unika Medical Centre at 1 site in Canada.
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 1 inclusion and 6 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 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. 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?
Percentage of patients with a matching diagnosis between telehealth and in-person consultation (time frame: 6 months). 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 21 Apr 2021.