Cognitive ImpairmentENFORCERNCT06395558
intErnet-based iNterventions FOR Cardiac arrEst suRvivors
A study testing Lifestyle intervention in people with Cognitive Impairment and Depression, Anxiety, run by Azienda Usl di Bologna at 2 sites in Italy.
Trial summary
This randomized clinical trial will test whether an internet-based lifestyle intervention administered through a web app can foster Health Related Quality of Life in patients who survived an out-of-hospital cardiac arrest and suffer from these symptoms Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cognitive Impairment, Depression, Anxiety, Cardiac Arrest
- What is being tested?
- Lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 2 sitesItaly
- Study dates
- 5 Aug 2024to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospital discharge after out-of-hospital cardiac arrest with Cerebral Performance Category 1 or 2
- Informed consent for participation in the study
- Native Italian speaker or adequate understanding of the Italian language
- Adequate ability to use the web to guarantee access to the contents
Who cannot join
- Previous cognitive dysfunction
- Previous psychiatric disease
- Previous episode of out-of-hospital cardiac arrest
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pamela Salucci, MD contact
Italy2 sites, 2 recruiting
- Recruiting
Azienda Unità Sanitaria Locale
Bologna, Bologna, 40100
Lorenzo Gamberini
- Recruiting
Montecatone Rehabilitation Institute
Imola, Bologna, 40026
Pamela Salucci, MD, pamela.salucci@montecatone.com
About this study
Official title: Internet-Based Interventions for Cardiac Arrest Survivors
This randomized clinical trial will test whether an internet-based lifestyle intervention administered through a web app can foster Health Related Quality of Life in patients who survived an out-of-hospital cardiac arrest and suffer from these symptoms
- Conditions
- Cognitive Impairment, Depression, Anxiety, Cardiac Arrest, Quality of Life, Social Functioning, Sexual Dysfunction
- Being tested
- Lifestyle intervention
- Medical subject headings
- Cognitive Dysfunction, Depression, Anxiety Disorders, Heart Arrest, Social Adjustment, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionBehavioural
Multimodal web-based intervention programme on anxiety, depression and cognitive impairment consisting of knowledge development sessions and practical/gaming sessions focused on different domains: cognitive competence, socio-relational competence and emotions/affectivity, and physical activity-nutrition
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention | Experimental | Not described Receives: Behavioral: Lifestyle intervention |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Related Quality of Life
SF-12 Health Survey
Measured: 12 months
Secondary outcomes (12)
HADS (Hospital Anxiety and Depression Scale) value
Depression and anxiety symptoms
Measured: 12 months
TICS (Telephone Interview for Cognitive Status)
Cognitive symptoms
Measured: 12 months
SF-12 (Short Form Health Survey 36)
Health Related Quality of Life
Measured: 12 months
NRS (Neurobehavioural rating scale), PCRS (Patient Competency Rating Scale)
Behavioural symptoms
Measured: 12 months
NRS (Neurobehavioural rating scale)
Behavioural symptoms
Measured: 12 months
Pittsburgh Sleep Quality Index (PSQI)
Sleep Quality
Measured: 12 months
Sexual Interest and Satisfaction Scale (SISS)
Sexual Interest and Satisfaction
Measured: 12 months
Zarit Burden Inventory (ZBI)
Caregiver Burden
Measured: 12 months
PCRS (Patient Competency Rating Scale)
Behavioural symptoms
Measured: 12 months
HADS (Hospital Anxiety and Depression Scale) - Caregiver
Caregiver's depression and anxiety symptoms
Measured: 12 months
PSQI (Pittsburgh Sleep Quality Index) - Caregiver
Caregiver's sleep quality
Measured: 12 months
SF-12 (Short Form Health Survey 36) - Caregiver
Caregiver's Health Related Quality of Life
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start5 Aug 2024
- Primary completion5 Aug 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
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 Cognitive ImpairmentStudies 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
- Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Collaborators
- Montecatone Rehabilitation Institute S.p.A.
- Responsible party
- Sponsor
- Investigators
- Lorenzo Gamberini, MD, Principal investigator, Azienda USL Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395558
- Sponsor's protocol ID
- ENFORCER
- Acronym
- ENFORCER
- Status last verified
- Mar 2026
- First submitted
- 24 Apr 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Fully anonymized patient data will be shared in an online repository
Publications
Gamberini L, Rucci P, Dolcini C, Masi M, Simoncini L, Tartaglione M, Del Giudice D, Domina R, Fagiolini A, Salucci P; Collaborators. ENFORCER, internet-based interventions for cardiac arrest survivors: A study protocol for a randomised, parallel-group, multicentre clinical trial. Resusc Plus. 2024 Sep 18;20:100772. doi: 10.1016/j.resplu.2024.100772. eCollection 2024 Dec.
PubMed 39328897
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Based Interventions for Cardiac Arrest Survivors
- ClinicalTrials.gov ID
- NCT06395558
- Acronym / sponsor ID
- ENFORCER / ENFORCER
- Conditions
- Cognitive Impairment, Depression, Anxiety, Cardiac Arrest, Quality of Life, Social Functioning, Sexual Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Collaborators
- Montecatone Rehabilitation Institute S.p.A.
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 5 Aug 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 2 May 2024 (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 randomized clinical trial will test whether an internet-based lifestyle intervention administered through a web app can foster Health Related Quality of Life in patients who survived an out-of-hospital cardiac arrest and suffer from these symptoms
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention | Experimental | Behavioral: Lifestyle intervention |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hospital discharge after out-of-hospital cardiac arrest with Cerebral Performance Category 1 or 2
- Informed consent for participation in the study
- Native Italian speaker or adequate understanding of the Italian language
- Adequate ability to use the web to guarantee access to the contents
Key exclusion criteria (3 listed)
- Previous cognitive dysfunction
- Previous psychiatric disease
- Previous episode of out-of-hospital cardiac arrest
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 |
|---|---|---|
| Lifestyle interventionMultimodal web-based intervention programme on anxiety, depression and cognitive impairment consisting of knowledge development sessions and practical/gaming sessions focused on different domains: cognitive competence, socio-relational competence and emotions/affectivity, and physical activity-nutrition | Behavioural | Lifestyle intervention |
Primary outcome
Health Related Quality of Life
Time frame: 12 months
SF-12 Health Survey
12 secondary outcomes
HADS (Hospital Anxiety and Depression Scale) value
Time frame: 12 months
TICS (Telephone Interview for Cognitive Status)
Time frame: 12 months
SF-12 (Short Form Health Survey 36)
Time frame: 12 months
NRS (Neurobehavioural rating scale), PCRS (Patient Competency Rating Scale)
Time frame: 12 months
NRS (Neurobehavioural rating scale)
Time frame: 12 months
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 12 months
Sexual Interest and Satisfaction Scale (SISS)
Time frame: 12 months
Zarit Burden Inventory (ZBI)
Time frame: 12 months
PCRS (Patient Competency Rating Scale)
Time frame: 12 months
HADS (Hospital Anxiety and Depression Scale) - Caregiver
Time frame: 12 months
PSQI (Pittsburgh Sleep Quality Index) - Caregiver
Time frame: 12 months
SF-12 (Short Form Health Survey 36) - Caregiver
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Derived from this study: PubMed 39328897Gamberini L, Rucci P, Dolcini C, Masi M, Simoncini L, Tartaglione M, Del Giudice D, Domina R, Fagiolini A, Salucci P; Collaborators. ENFORCER, internet-based interventions for cardiac arrest survivors: A study protocol for a randomised, parallel-group, multicentre clinical trial. Resusc Plus. 2024 Sep 18;20:100772. doi: 10.1016/j.resplu.2024.100772. eCollection 2024 Dec.
- Individual participant dataSharing planned: Yes. Fully anonymized patient data will be shared in an online repository
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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.
Pamela Salucci, MD contact
Lorenzo Gamberini, MD principal investigator
Azienda USL Bologna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention in people with Cognitive Impairment and Depression, Anxiety, run by Azienda Usl di Bologna 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 4 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: looking for participants now, as of the sponsor's last update on 30 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo Gamberini, MD (3403550540 ext. +39, gamberini6@ausl.bologna.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Related Quality of Life (time frame: 12 months). 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 NCT06395558, 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 30 Mar 2026.