RehabilitationNCT04408196
QoL and the Emotional-affective Sphere in Rehabilitation Setting During COVID-19 Quarantine
An observational study of Rehabilitation, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
Coronavirus disease (COVID-19) is caused by the Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) virus. This virus was identified in December 2019 in the Chinese city of Wuhan, in the province of Hubei, where it determined a state of health emergency proclaimed by China on January 30, 2020. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rehabilitation
- How many people
- 121 participants
- Where
- 1 siteItaly
- Study dates
- 26 May 2020to 22 Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients admitted to inpatients rehabilitation centers Caregivers of patients admitted to inpatients rehabilitation centers
Who may be able to join
- patients admitted to the centers of the Don Gnocchi Foundation participating in the study and their caregivers will be recruited
Who cannot join
- For patients: a score on the Mini-Mental State Examination (MMSE) scale lower than 24 which prevents the administration of SF36;
- For patients and caregivers: failure to acquire informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Social Distancing on the Quality of Life and on the Emotional-affective Sphere of Caregivers and Patients Hospitalized in Residential Rehabilitation Departments: an Observational Study.
Coronavirus disease (COVID-19) is caused by the Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) virus. This virus was identified in December 2019 in the Chinese city of Wuhan, in the province of Hubei, where it determined a state of health emergency proclaimed by China on January 30, 2020.
Since February 2020, Italy has been involved in the emergency of the COVID-19 infection, with devastating consequences for the health of the population and the economy of our country. As published by the Italian National Institute of Health, the starting date of the symptoms dates back to the end of January, the first case diagnosed dates back to 21 February 2020 while the first cases of home isolation date back to March 1st, 2020. On March 30, 2020, there were 101739 positive subjects and 11591 deaths (Civil Protection data).
Read more
According to data published by the World Health Organization, most people with COVID-19 develop a flu-like form, 14% develop a severe form that requires hospitalization and oxygen therapy and 5% require an ICU admission.
The emergency from Covid19 made it necessary to provide institutional social distancing conditions which resulted in rehabilitation departments being prohibited from visiting patients by family members and/or caregivers. This event, although necessary, led to the first moment of discomfort on the part of patients and family members; to overcome this reaction "technological" solutions were found, trying to give continuity to the contact between the patient and the family member through the use of video calls. Despite this, the COVID-19 emergency and the limitations resulting from social distancing likely have an impact on both patients and family members/caregivers that needs to be assessed.
Read the detailed description
Aims:
The study aims to measure the quality of life (QoL) and the emotional-affective sphere of patients, currently hospitalized in residential structures, and their family members.
The study data will allow identifying (a) whether the social distancing between family members/caregivers and patients undergoing rehabilitation for orthopedic or neurological disabilities affects the quality of life and the emotional-affective sphere and (b) if these conditions change over time. The data obtained will, therefore, allow identifying those subjects who present a particular fragility of the emotional-affective sphere and who therefore need attention and possibly psychological support that will be prescribed.
Procedures:
Demographic (for patients and caregivers) and anamnestic (only for patients) data will be collected; moreover, disability will be assessed in patients using the modified Barthel index.
Three questionnaires will be administered to patients and caregivers:
- The Short Form (36) Health Survey (SF36), to evaluate the QoL;
- The Beck Anxiety Inventory (BAI), to evaluate the emotional state;
- The Beck Depression Inventory-II (BDI-II), to evaluate mood.
These questionnaires will be administered after one month of hospitalization (T0), and after one (T1) and two (T2) months after T0. Finally, at time T1 and T2 it will be registered if the patient is still hospitalized or discharged (and in the latter case the days between the discharge and the compilation of the questionnaire will be recorded). Since the three selected questionnaires provide for self-administration, to simplify the collection of data relating to caregivers, the implementation and use of an online questionnaire will be assessed. This questionnaire will also provide for the collection of consent to the use of data by the subject and will guarantee their privacy.
- Conditions
- Rehabilitation
- Keywords
- rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | 100 patients admitted to an inpatient rehabilitation facility | |
| Caregivers | 100 caregivers of patients admitted to an inpatient rehabilitation facility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form-36 Health Survey (SF36)
It is a questionnaire to evaluate the Quality of Life
Measured: After one month of hospitalisation (baseline, T0)
Short Form (36) Health Survey (SF36)
It is a questionnaire to evaluate the Quality of Life
Measured: One month after baseline (T1)
Short Form (36) Health Survey (SF36)
It is a questionnaire to evaluate the Quality of Life
Measured: Two months after baseline (T2)
Beck Anxiety Inventory (BAI)
It is a brief, criteria-referenced assessment for measuring anxiety severity and level
Measured: After one month of hospitalisation (baseline,T0)
Beck Anxiety Inventory (BAI)
It is a brief, criteria-referenced assessment for measuring anxiety severity and level
Measured: One month after baseline (T1)
Beck Anxiety Inventory (BAI)
It is a brief, criteria-referenced assessment for measuring anxiety severity and level
Measured: Two months after baseline (T2)
Beck Depression Inventory-II (BDI-II)
It is a brief, criteria-referenced assessment for measuring depression severity
Measured: After one month of hospitalisation (baseline)
Beck Depression Inventory-II (BDI-II)
It is a brief, criteria-referenced assessment for measuring depression severity
Measured: One month after baseline (T1)
Beck Depression Inventory-II (BDI-II)
It is a brief, criteria-referenced assessment for measuring depression severity
Measured: Two months after baseline (T2)
Secondary outcomes (1)
modified Barthel Index (mBI)
It is a measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients or patients with other disabling conditions.
Measured: After one month of hospitalisation (baseline, T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start26 May 2020
- Primary completion15 Feb 2021
- Study completion22 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- 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
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene Giovanna Aprile, Fondazione Don Carlo Gnocchi ETS
- Investigators
- Irene APRILE, MD,PHD, Principal investigator, IRCCS Fondazione Don Carlo Gnocchi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408196
- Sponsor's protocol ID
- FDG_socialdistancing_COVID-19
- Status last verified
- Mar 2022
- First submitted
- 21 May 2020
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Apolone G, Mosconi P. The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol. 1998 Nov;51(11):1025-36. doi: 10.1016/s0895-4356(98)00094-8.
PubMed 9817120Aprile I, Piazzini DB, Bertolini C, Caliandro P, Pazzaglia C, Tonali P, Padua L. Predictive variables on disability and quality of life in stroke outpatients undergoing rehabilitation. Neurol Sci. 2006 Apr;27(1):40-6. doi: 10.1007/s10072-006-0563-5.
PubMed 16688598
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Social Distancing on the Quality of Life and on the Emotional-affective Sphere of Caregivers and Patients Hospitalized in Residential Rehabilitation Departments: an Observational Study.
- ClinicalTrials.gov ID
- NCT04408196
- Acronym / sponsor ID
- FDG_socialdistancing_COVID-19
- Conditions
- Rehabilitation
- Keywords
- rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 26 May 2020 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 22 Feb 2021 (actual)
- First posted
- 29 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.
Coronavirus disease (COVID-19) is caused by the Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) virus. This virus was identified in December 2019 in the Chinese city of Wuhan, in the province of Hubei, where it determined a state of health emergency proclaimed by China on January 30, 2020.
Since February 2020, Italy has been involved in the emergency of the COVID-19 infection, with devastating consequences for the health of the population and the economy of our country. As published by the Italian National Institute of Health, the starting date of the symptoms dates back to the end of January, the first case diagnosed dates back to 21 February 2020 while the first cases of home isolation date back to March 1st, 2020. On March 30, 2020, there were 101739 positive subjects and 11591 deaths (Civil Protection data).
According to data published by the World Health Organization, most people with COVID-19 develop a flu-like form, 14% develop a severe form that requires hospitalization and oxygen therapy and 5% require an ICU admission.
The emergency from Covid19 made it necessary to provide institutional social distancing conditions which resulted in rehabilitation departments being prohibited from visiting patients by family members and/or caregivers. This event, although necessary, led to the first moment of discomfort on the part of patients and family members; to overcome this reaction "technological" solutions were found, trying to give continuity to the contact between the patient and the family member through the use of video calls. Despite this, the COVID-19 emergency and the limitations resulting from social distancing likely have an impact on both patients and family members/caregivers that needs to be assessed.
Detailed description
Aims:
The study aims to measure the quality of life (QoL) and the emotional-affective sphere of patients, currently hospitalized in residential structures, and their family members.
The study data will allow identifying (a) whether the social distancing between family members/caregivers and patients undergoing rehabilitation for orthopedic or neurological disabilities affects the quality of life and the emotional-affective sphere and (b) if these conditions change over time. The data obtained will, therefore, allow identifying those subjects who present a particular fragility of the emotional-affective sphere and who therefore need attention and possibly psychological support that will be prescribed.
Procedures:
Demographic (for patients and caregivers) and anamnestic (only for patients) data will be collected; moreover, disability will be assessed in patients using the modified Barthel index.
Three questionnaires will be administered to patients and caregivers:
- The Short Form (36) Health Survey (SF36), to evaluate the QoL;
- The Beck Anxiety Inventory (BAI), to evaluate the emotional state;
- The Beck Depression Inventory-II (BDI-II), to evaluate mood.
These questionnaires will be administered after one month of hospitalization (T0), and after one (T1) and two (T2) months after T0. Finally, at time T1 and T2 it will be registered if the patient is still hospitalized or discharged (and in the latter case the days between the discharge and the compilation of the questionnaire will be recorded). Since the three selected questionnaires provide for self-administration, to simplify the collection of data relating to caregivers, the implementation and use of an online questionnaire will be assessed. This questionnaire will also provide for the collection of consent to the use of data by the subject and will guarantee their privacy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –100 patients admitted to an inpatient rehabilitation facility |
| Caregivers | – | –100 caregivers of patients admitted to an inpatient rehabilitation facility |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to inpatients rehabilitation centers Caregivers of patients admitted to inpatients rehabilitation centers
Key inclusion criteria (1 listed)
- patients admitted to the centers of the Don Gnocchi Foundation participating in the study and their caregivers will be recruited
Key exclusion criteria (2 listed)
- For patients: a score on the Mini-Mental State Examination (MMSE) scale lower than 24 which prevents the administration of SF36;
- For patients and caregivers: failure to acquire informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Short Form-36 Health Survey (SF36)
Time frame: After one month of hospitalisation (baseline, T0)
It is a questionnaire to evaluate the Quality of Life
Short Form (36) Health Survey (SF36)
Time frame: One month after baseline (T1)
It is a questionnaire to evaluate the Quality of Life
Short Form (36) Health Survey (SF36)
Time frame: Two months after baseline (T2)
It is a questionnaire to evaluate the Quality of Life
Beck Anxiety Inventory (BAI)
Time frame: After one month of hospitalisation (baseline,T0)
It is a brief, criteria-referenced assessment for measuring anxiety severity and level
Beck Anxiety Inventory (BAI)
Time frame: One month after baseline (T1)
It is a brief, criteria-referenced assessment for measuring anxiety severity and level
Beck Anxiety Inventory (BAI)
Time frame: Two months after baseline (T2)
It is a brief, criteria-referenced assessment for measuring anxiety severity and level
Beck Depression Inventory-II (BDI-II)
Time frame: After one month of hospitalisation (baseline)
It is a brief, criteria-referenced assessment for measuring depression severity
Beck Depression Inventory-II (BDI-II)
Time frame: One month after baseline (T1)
It is a brief, criteria-referenced assessment for measuring depression severity
Beck Depression Inventory-II (BDI-II)
Time frame: Two months after baseline (T2)
It is a brief, criteria-referenced assessment for measuring depression severity
1 secondary outcome
modified Barthel Index (mBI)
Time frame: After one month of hospitalisation (baseline, T0)
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 7 Apr 2022.
- Background: PubMed 9817120Apolone G, Mosconi P. The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol. 1998 Nov;51(11):1025-36. doi: 10.1016/s0895-4356(98)00094-8.
- Background: PubMed 16688598Aprile I, Piazzini DB, Bertolini C, Caliandro P, Pazzaglia C, Tonali P, Padua L. Predictive variables on disability and quality of life in stroke outpatients undergoing rehabilitation. Neurol Sci. 2006 Apr;27(1):40-6. doi: 10.1007/s10072-006-0563-5.
- 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.
Irene APRILE, MD,PHD principal investigator
IRCCS Fondazione Don Carlo Gnocchi
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 Rehabilitation, run by Fondazione Don Carlo Gnocchi ETS at 1 site 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 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 7 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 1 site 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?
Short Form-36 Health Survey (SF36) (time frame: After one month of hospitalisation (baseline, T0)). The study lists 9 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 NCT04408196, which also lists 2 linked publications.
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 7 Apr 2022.