HypothyroidismTIAMONCT05314790
Management of Patients With Diagnosis of Hypothyroidism, as Hospitalized and as Outpatients, in Internal Medicine Units: Observational Study Before & After Educational Programme
An observational study of Hypothyroidism, run by Fadoi Foundation, Italy at 20 sites in Italy.
Trial summary
There is still limited knowledge regarding the clinical profile and appropriateness of treatment in patients with hypothyroidism hospitalized in Internal Medicine (IM) Departments in Italy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- intervening Educational Program
- How many people
- 1,200 participants
- Where
- 20 sitesItaly
- Study dates
- 1 Jun 2016to 1 Jan 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients with known diagnosis of hypothyroidism on the basis of medical history or laboratory results,as hospitalized and as outpatients, in Internal Medicine Units
Who may be able to join
- known diagnosis of hypothyroidism on the basis of medical history or laboratory results, as indicated in the clinical record of inpatients admitted to the IM department for any condition
Who cannot join
- none
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Italy20 sites
ULSS1 Belluno San Martino
Belluno
Ospedale Versilia
Camaiore
Ospedale di Canicattì
Canicattì
Ospedale di Castiglione del Lago, Medicina del Trasimeno
Castiglione del Lago
Garibaldi Nesima
Catania
Ospedale G.B. Morgagni - P.L. Pierantoni
Forlì
Ospedale G.P. Delogu
Ghilarza
Ospedale Gubbio-Gualdo Tadino
Gubbio
Ospedale "F. Veneziale"
Isernia
ASL Latina
Latina
Ospedale S. Andrea
Massa Marittima
Ospedale S. Croce di Moncalieri - ASL TO5
Moncalieri
Ospedale Del Mare
Naples
Ospedale Fatebenefratelli
Naples
Ospedale Maggiore di Novara
Novara
Ospedale Civico di Partinico
Palermo
Ospedale "Bianchi-Melacrino-Morelli"
Reggio Calabria
Casa Sollievo della Sofferenza
San Giovanni Rotondo
AOU di Sassari
Sassari
Ospedale San Paolo
Savona
About this study
There is still limited knowledge regarding the clinical profile and appropriateness of treatment in patients with hypothyroidism hospitalized in Internal Medicine (IM) Departments in Italy. The aim of this study is to evaluate: 1) the characteristics of patients and possible deviations from national and international clinical practice recommendations (CPRs) in evidence-based guidelines (EBGs); 2) the improvement of patient management by means of a standardized educational programme (EP).
Methods: A nationwide multicentre study, comprising two replications of a retrospective survey (phases 1 and 3) with an intervening EP (phase 2) in half of the centres and no EP in the other half, was conducted. The EP was based on outreach visits. Centres were assigned to the two arms of the study, labelled the training group (TG) and control group (CG) respectively, by cluster randomization.
Read the detailed description
Hypothyroidism (HT) is a common disorder that affects more than 4% of the general population. Since this percentage does increase with advancing age, it is reasonable to suppose that hypothyroidism is becoming a widespread disease condition. Furthermore hypothyroidism is correlated with significant cardiovascular morbidity and mortality.
Although the potential clinical impact of hypothyroidism, the clinical profile of patients affected by hypothyroidism and managed in the Internal Medicine setting it is not very well known so far. This study has the aim to take a real-life picture of Internal Medicine patients with diagnosis of hypothyroidism, in order to evaluate possible deviations between the current clinical practice and the evidence-based guidelines, and possibly improving the management by means of an educational program.
The FADOI-TIAMO study is designed as a replicate of two cross-sectional surveys (Phase 1 and 3) interspersed with an educational program (Phase 2) to be conducted in 11 out of the 22 participating Centres. The data collection in Phases 1 and 3 will be based on the review of medical records of the last 30 consecutive patients with known or de novo diagnosis of HT observed in each Centre (globally, 1200 patients).
- Conditions
- Hypothyroidism
- Being tested
- intervening Educational Program
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervening Educational ProgramOther
The implementation of an EP is based on meetings within the Department, coordinated by an outside tutor (outreach visit model). The EP content was defined beforehand by a Scientific Board, on the basis of evidence-based guidelines (EBGs) and an up-to-date literature review, but also with a specific focus on any departures from standard clinical practice recommendations (CPRs) identified at each IM department in phase 1;
| Study group | Role | What they receive |
|---|---|---|
| control group (CG) | Without intervening Educational Program | |
| training group (TG) | Group who has received an Educational Program (EP). The implementation of an EP based on meetings within the Department, coordinated by an outside tutor (outreach visit model). The EP content was defined beforehand by a Scientific Board, on the basis of evidence-based guidelines (EBGs) and an up-to-date literature review, but also with a specific focus on any departures from standard clinical practice recommendations (CPRs) identified at each IM department in phase 1. Receives: Other: intervening Educational Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate any possible offset between treatment standards for hypothyroidism and the real-life management of patient
To evaluate, in the real-life management of the hypothyroidism therapy, possible deviations from national and international clinical practice recommendations (CPR) in evidence-based guidelines (EBGs). Four EBGs and 39 CPRs have provided the basis on which 22 treatment management indicators have been identified (e.g. Number of Patients on LT4 replacement therapy who are not taking oral solution or softgel formulations are on absorption-hindering medication and/or do not comply with timing in relation to meals / Number of patients on LT4 replacement therapy who do not comply with the prescribed timing before meals and/or are taking absorption-hindering medication; Number of patients on replacement therapy with TSH in the ATA target range/ Number of patients on replacement therapy with known TSH; Number of patients on replacement therapy, taking LT4 tablets at least 60' before breakfast or at least 3 h after dinner / Number of patients on replacement therapy with LT4 tablets)
Measured: 4 months for each phase
Effects of an educational programme
To evaluate the improvement of some indicators (the same of outcome 1) in the management of patients with hypothyroidism by means of a standardized educational programme (e.g. Number of Patients on LT4 replacement therapy who are not taking oral solution or softgel formulations are on absorption-hindering medication and/or do not comply with timing in relation to meals / Number of patients on LT4 replacement therapy who do not comply with the prescribed timing before meals and/or are taking absorption-hindering medication; Number of patients on replacement therapy with TSH in the ATA target range/ Number of patients on replacement therapy with known TSH; Number of patients on replacement therapy, taking LT4 tablets at least 60' before breakfast or at least 3 h after dinner / Number of patients on replacement therapy with LT4 tablets)
Measured: 4 months for each phase
Secondary outcomes (1)
Clinical profile evaluation of hypothyroidism
Assessment of age, gender, weight, hormonal hypothyroidism status (TSH, FT3, FT4), comorbidity, treatment of hypothyroidism and other pharmacological therapies of patients with hypothyroidism
Measured: 4 months for each phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 Jun 2016
- Primary completion1 Jan 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypothyroidismStudies 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
- Retrospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fadoi Foundation, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MAURO CAMPANINI, Study director, FADOI FOUNDATION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314790
- Sponsor's protocol ID
- FADOI.05.2015
- Acronym
- TIAMO
- Status last verified
- Mar 2022
- First submitted
- 20 Jan 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brancato D, Biondi B, Attardo TM, Fierro A, Nizzoli M, Vettor R, Monaco E, Romano R, Ariete V, Usai C, Zagarri E, Campanini M. Management of Hypothyroidism in Internal Medicine: Patient Profile and Effects of an Educational Programme in the Cluster-Randomized FADOI TIAMO Study. Front Endocrinol (Lausanne). 2022 Jun 13;13:839300. doi: 10.3389/fendo.2022.839300. eCollection 2022.
PubMed 35769080
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Patients With Diagnosis of Hypothyroidism, as Hospitalized and as Outpatients, in Internal Medicine Units: Observational Study Before & After Educational Programme
- ClinicalTrials.gov ID
- NCT05314790
- Acronym / sponsor ID
- TIAMO / FADOI.05.2015
- Conditions
- Hypothyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Fadoi Foundation, ItalyUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 6 Apr 2022 (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.
There is still limited knowledge regarding the clinical profile and appropriateness of treatment in patients with hypothyroidism hospitalized in Internal Medicine (IM) Departments in Italy. The aim of this study is to evaluate: 1) the characteristics of patients and possible deviations from national and international clinical practice recommendations (CPRs) in evidence-based guidelines (EBGs); 2) the improvement of patient management by means of a standardized educational programme (EP).
Methods: A nationwide multicentre study, comprising two replications of a retrospective survey (phases 1 and 3) with an intervening EP (phase 2) in half of the centres and no EP in the other half, was conducted. The EP was based on outreach visits. Centres were assigned to the two arms of the study, labelled the training group (TG) and control group (CG) respectively, by cluster randomization.
Detailed description
Hypothyroidism (HT) is a common disorder that affects more than 4% of the general population. Since this percentage does increase with advancing age, it is reasonable to suppose that hypothyroidism is becoming a widespread disease condition. Furthermore hypothyroidism is correlated with significant cardiovascular morbidity and mortality.
Although the potential clinical impact of hypothyroidism, the clinical profile of patients affected by hypothyroidism and managed in the Internal Medicine setting it is not very well known so far. This study has the aim to take a real-life picture of Internal Medicine patients with diagnosis of hypothyroidism, in order to evaluate possible deviations between the current clinical practice and the evidence-based guidelines, and possibly improving the management by means of an educational program.
The FADOI-TIAMO study is designed as a replicate of two cross-sectional surveys (Phase 1 and 3) interspersed with an educational program (Phase 2) to be conducted in 11 out of the 22 participating Centres. The data collection in Phases 1 and 3 will be based on the review of medical records of the last 30 consecutive patients with known or de novo diagnosis of HT observed in each Centre (globally, 1200 patients).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group (CG) | – | –Without intervening Educational Program |
| training group (TG) | – | Other: intervening Educational ProgramGroup who has received an Educational Program (EP). The implementation of an EP based on meetings within the Department, coordinated by an outside tutor (outreach visit model). The EP content was defined beforehand by a Scientific Board, on the basis of evidence-based guidelines (EBGs) and an up-to-date literature review, but also with a specific focus on any departures from standard clinical practice recommendations (CPRs) identified at each IM department in phase 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with known diagnosis of hypothyroidism on the basis of medical history or laboratory results,as hospitalized and as outpatients, in Internal Medicine Units
Key inclusion criteria (1 listed)
- known diagnosis of hypothyroidism on the basis of medical history or laboratory results, as indicated in the clinical record of inpatients admitted to the IM department for any condition
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| intervening Educational ProgramThe implementation of an EP is based on meetings within the Department, coordinated by an outside tutor (outreach visit model). The EP content was defined beforehand by a Scientific Board, on the basis of evidence-based guidelines (EBGs) and an up-to-date literature review, but also with a specific focus on any departures from standard clinical practice recommendations (CPRs) identified at each IM department in phase 1; | Other | training group (TG) |
Primary outcome
To evaluate any possible offset between treatment standards for hypothyroidism and the real-life management of patient
Time frame: 4 months for each phase
To evaluate, in the real-life management of the hypothyroidism therapy, possible deviations from national and international clinical practice recommendations (CPR) in evidence-based guidelines (EBGs). Four EBGs and 39 CPRs have provided the basis on which 22 treatment management indicators have been identified (e.g. Number of Patients on LT4 replacement therapy who are not taking oral solution or softgel formulations are on absorption-hindering medication and/or do not comply with timing in relation to meals / Number of patients on LT4 replacement therapy who do not comply with the prescribed timing before meals and/or are taking absorption-hindering medication; Number of patients on replacement therapy with TSH in the ATA target range/ Number of patients on replacement therapy with known TSH; Number of patients on replacement therapy, taking LT4 tablets at least 60' before breakfast or at least 3 h after dinner / Number of patients on replacement therapy with LT4 tablets)
Effects of an educational programme
Time frame: 4 months for each phase
To evaluate the improvement of some indicators (the same of outcome 1) in the management of patients with hypothyroidism by means of a standardized educational programme (e.g. Number of Patients on LT4 replacement therapy who are not taking oral solution or softgel formulations are on absorption-hindering medication and/or do not comply with timing in relation to meals / Number of patients on LT4 replacement therapy who do not comply with the prescribed timing before meals and/or are taking absorption-hindering medication; Number of patients on replacement therapy with TSH in the ATA target range/ Number of patients on replacement therapy with known TSH; Number of patients on replacement therapy, taking LT4 tablets at least 60' before breakfast or at least 3 h after dinner / Number of patients on replacement therapy with LT4 tablets)
1 secondary outcome
Clinical profile evaluation of hypothyroidism
Time frame: 4 months for each phase
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 6 Apr 2022.
- Derived from this study: PubMed 35769080Brancato D, Biondi B, Attardo TM, Fierro A, Nizzoli M, Vettor R, Monaco E, Romano R, Ariete V, Usai C, Zagarri E, Campanini M. Management of Hypothyroidism in Internal Medicine: Patient Profile and Effects of an Educational Programme in the Cluster-Randomized FADOI TIAMO Study. Front Endocrinol (Lausanne). 2022 Jun 13;13:839300. doi: 10.3389/fendo.2022.839300. eCollection 2022.
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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.
MAURO CAMPANINI study director
FADOI FOUNDATION
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothyroidism, run by Fadoi Foundation, Italy at 20 sites in Italy.
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 1 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 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Italy. 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?
To evaluate any possible offset between treatment standards for hypothyroidism and the real-life management of patient (time frame: 4 months for each phase). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05314790, which also lists 1 linked publication.
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 6 Apr 2022.