Mental Health IssueTFUNCT04793282
The Benefits of Telephone Follow-up (TFU)
A study testing Telephone Follow-up in people with Mental Health Issue, run by Brandon University at 1 site in Canada.
Trial summary
This study will investigate the impact of a brief telephone follow-up following a mental health assessment in the emergency department. The purpose of the telephone call will be to provide psycho-education, clarify any questions and reinforce discharge planning. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Telephone Follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- 2 Aug 2022to 1 Aug 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Discharged from the ED
- Age of majority
- Competent.
Who cannot join
- Incompetent,
- Under 18
- Admitted to the hospital
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6
Alana E Prejet, BScPN, 204.235.3053, prejetae05@brandonu.ca
About this study
Official title: The Benefits of Telephone Follow-Up After a Mental Health Assessment in an Emergency Department
This study will investigate the impact of a brief telephone follow-up following a mental health assessment in the emergency department. The purpose of the telephone call will be to provide psycho-education, clarify any questions and reinforce discharge planning.
Read the detailed description
This is a randomized controlled trial. The experimental group will receive a phone call within 72 hours of discharge to provide psycho education, clarify any questions they may have and to reinforce discharge plans made in the ED. The control group will not receive this phone call. Within 30 days of discharge, both groups will receive a phone call to collect data on treatment compliance including medication and follow-up adherence and if any additional visits to the Emergency Department were necessary.
- Conditions
- Mental Health Issue
- Being tested
- Telephone Follow-up
- Keywords
- Telephone follow up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone Follow-upBehavioural
Telephone Follow-up within 72 hours to discuss psycho education, discharge planning and clarify any questions they may have.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Post-test satisfaction Receives: Behavioral: Telephone Follow-up |
| Experimental | Experimental | Treatment and satisfaction Receives: Behavioral: Telephone Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency Department readmission rates
Does a telephone call reduce readmission rates?
Measured: 30 days.
Secondary outcomes (3)
Satisfaction with care in the Emergency Department using a 7 point Likert Scale as a function of the telephone follow up.
Various measures of satisfaction in care provided in Emergency Department. Higher scores indicate higher satisfaction.
Measured: 30 days.
Adherence to pharmacological interventions and follow-up appointments.
Adhering to pharmacological interventions and follow-up appointments by self rating on a 7 point Likert Scale. Higher scores indicate greater adherence to treatment adherence.
Measured: 30 days.
Understanding of Treatment plan
Assessing if the participant believes they have a good understanding of their care plan by self rating on a 7 point Likert Scale. Higher scores indicate greater understanding of treatment plan.
Measured: 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start2 Aug 2022
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brandon University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alana Prejet, Brandon University
- Investigators
- Alana E Prejet, BScPN, BA, Principal investigator, Brandon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793282
- Sponsor's protocol ID
- BrandonU
- Acronym
- TFU
- Status last verified
- Aug 2022
- First submitted
- 23 Feb 2021
- Last updated
- 8 Aug 2022
- 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 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefits of Telephone Follow-Up After a Mental Health Assessment in an Emergency Department
- ClinicalTrials.gov ID
- NCT04793282
- Acronym / sponsor ID
- TFU / BrandonU
- Conditions
- Mental Health Issue
- Keywords
- Telephone follow up
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Brandon UniversityUniversity, hospital or other
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 11 Mar 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.
This study will investigate the impact of a brief telephone follow-up following a mental health assessment in the emergency department. The purpose of the telephone call will be to provide psycho-education, clarify any questions and reinforce discharge planning.
Detailed description
This is a randomized controlled trial. The experimental group will receive a phone call within 72 hours of discharge to provide psycho education, clarify any questions they may have and to reinforce discharge plans made in the ED. The control group will not receive this phone call. Within 30 days of discharge, both groups will receive a phone call to collect data on treatment compliance including medication and follow-up adherence and if any additional visits to the Emergency Department were necessary.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: Telephone Follow-upPost-test satisfaction |
| Experimental | Experimental | Behavioral: Telephone Follow-upTreatment and satisfaction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Discharged from the ED
- Age of majority
- Competent.
Key exclusion criteria (3 listed)
- Incompetent,
- Under 18
- Admitted to the hospital
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 |
|---|---|---|
| Telephone Follow-upTelephone Follow-up within 72 hours to discuss psycho education, discharge planning and clarify any questions they may have. | Behavioural | Control, Experimental |
Primary outcome
Emergency Department readmission rates
Time frame: 30 days.
Does a telephone call reduce readmission rates?
3 secondary outcomes
Satisfaction with care in the Emergency Department using a 7 point Likert Scale as a function of the telephone follow up.
Time frame: 30 days.
Adherence to pharmacological interventions and follow-up appointments.
Time frame: 30 days.
Understanding of Treatment plan
Time frame: 30 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- 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.
Alana E Prejet, BScPN, BA principal investigator
Brandon University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone Follow-up in people with Mental Health Issue, run by Brandon University 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 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 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alana E Prejet, BScPN, BA (204-999-8882, prejetae05@brandonu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergency Department readmission rates (time frame: 30 days.). 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 8 Aug 2022.