AnxietyNCT05750420

Psychological Status and Self-care in Chronic Cardiovascular Disease

An observational study of Anxiety and Depression, run by Centro Cardiologico Monzino at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is an observational study aimed at exploring the relationship between psychological status and self-care in patients with chronic cardiovascular disease Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Anxiety, Depression, Emotional Stress
How many people: 400 participants
Where: 2 sitesItaly
Study dates: 28 Jul 2022to 12 Jan 2023
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 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Adult patients with chronic cardiovascular disease

Who may be able to join

Being aged > 18 years old and > 85 years old
Being diagnosed with a chronic cardiovascular disease
Being able and willing to sign the Informed Consent Form

Who cannot join

Having a cognitive dysfunction or psychotic disorder signaled in the clinical documentation
Not speaking Italian

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

Monzino Cardiology Center
Milan, 20138
IRCCS San Gerardo
Monza, 20900

Other trials in Italy

About this study

Official title: Psychological Status and Self-care: a Preliminary Study Involving Patients With Chronic Cardiovascular Disease

This is an observational study aimed at exploring the relationship between psychological status and self-care in patients with chronic cardiovascular disease

Read the detailed description

400 patients with chronic cardiovascular disease were enrolled in this observational study aiming at exploring the relationship between their psychological status (anxiety, depression, emotional distress and quality of life) and their self-care.

Conditions: Anxiety, Depression, Emotional Stress, Quality of Life, Self-care, Chronic Cardiovascular Disease
Being tested: There was no intervention, the study was a cross-sectional observational study
Medical subject headings: Anxiety Disorders, Depression, Stress, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

There was no intervention, the study was a cross-sectional observational studyOther
Questionnaires for measuring self-care, anxiety, depression, emotinal distress and quality of live were administered to patients with chronic cardiovascular disease

What is being measured

The primary outcome is the main question the study is designed to answer.

Psychological status and self-care
Investigating the relationship between psychological status and self-care in patients with chronic cardiovascular disease
Measured: At the moment of enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jul 202212 Jan 2023

First posted1 Mar 2023
Study start28 Jul 2022
Primary completion12 Jan 2023
Study completion12 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AnxietyStudies 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: Cross-sectional
Enrolment: 400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05750420
Sponsor's protocol ID: CCM1789
Status last verified: Apr 2023
First submitted: 20 Feb 2023
Last updated: 13 Apr 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Anxiety trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Psychological Status and Self-care: a Preliminary Study Involving Patients With Chronic Cardiovascular Disease
ClinicalTrials.gov ID: NCT05750420
Acronym / sponsor ID: CCM1789
Conditions: Anxiety, Depression, Emotional Stress, Quality of Life, Self-care, Chronic Cardiovascular Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 400 participants (actual)
Lead sponsor: Centro Cardiologico MonzinoUniversity, hospital or other
Study start: 28 Jul 2022 (actual)
Primary completion: 12 Jan 2023 (actual)
Study completion: 12 Jan 2023 (actual)
First posted: 1 Mar 2023 (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 observational study aimed at exploring the relationship between psychological status and self-care in patients with chronic cardiovascular disease

Detailed description

Study design

Observational model: Cohort
Time perspective: Cross-sectional

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Adult patients with chronic cardiovascular disease

Key inclusion criteria (3 listed)

Being aged > 18 years old and > 85 years old
Being diagnosed with a chronic cardiovascular disease
Being able and willing to sign the Informed Consent Form

Key exclusion criteria (2 listed)

Having a cognitive dysfunction or psychotic disorder signaled in the clinical documentation
Not speaking Italian

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
There was no intervention, the study was a cross-sectional observational studyQuestionnaires for measuring self-care, anxiety, depression, emotinal distress and quality of live were administered to patients with chronic cardiovascular disease	Other	–

Primary outcome

Psychological status and self-care
Time frame: At the moment of enrollment
Investigating the relationship between psychological status and self-care in patients with chronic cardiovascular disease

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 13 Apr 2023.
Individual participant dataSharing planned: No

Related trials for Anxiety

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Femoral Arterial Sheath Removal, Stress Ball
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Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
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Not yet recruitingObservational study
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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?

An observational study of Anxiety and Depression, run by Centro Cardiologico Monzino at 2 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 3 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 13 Apr 2023. 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 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?

Psychological status and self-care (time frame: At the moment of enrollment). 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 NCT05750420.

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 13 Apr 2023.