Heart FailureMOTIVATE-HFNCT02894502
MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients
A study testing Motivational interviewing in people with Heart Failure, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
The aims of this study will be to evaluate the effect of motivational interviewing (MI) to improve self-care in heart failure (HF) patients and caregiver contributions to HF self-care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2014to Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Diagnosis of HF (for patient), New York Heart Association (NYHA) functional class II- IV (for patient), Inadequate self-care assessed with the Self-Care Heart Failure Index (for patient), Being the informal caregiver of the patients (for caregiver).
Who cannot join
- Severe cognitive impairment evaluated with the Six-item screener (for patient), Acute coronary syndrome during the last three months (for patient), Living in a residential settings (e.g., nursing home) (for patient), Patients not willing to participate in the study (for caregiver).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients (MOTIVATE-HF): Study Protocol of a Three-arm Multicenter Randomized Controlled Trial
The aims of this study will be to evaluate the effect of motivational interviewing (MI) to improve self-care in heart failure (HF) patients and caregiver contributions to HF self-care. Also this study will evaluate the effect of MI on the following secondary outcomes: In HF patients: HF somatic symptom perception, generic and specific quality of life, anxiety and depression, sleep quality, mutuality with caregiver, hospitalizations, use of emergency services, and mortality; In caregivers: generic quality of life, anxiety and depression, mutuality with patient, preparedness, social support and sleep quality.
- Conditions
- Heart Failure
- Being tested
- Motivational interviewing
- Keywords
- Self-care, Motivational interviewing, Heart failure, Caregivers
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingBehavioural
The intervention will consist of a brief session of motivational interviewing (MI) performed by a trained nurse. During MI, the interventionist will address one or two aspects of self-care that the participants want to address. After this first intervention, the same interventionist will contact the participant by telephone to improve the first intervention and provide further support as needed. These telephone contact will be done three times at two week intervals following the first intervention (for a total of two months). Patients and caregivers that receive the intervention also will be given informational material on HF management that is consistent with international guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Motivational interviewing only for patients | Experimental | In this arm the interventions will be delivered only to patients Receives: Behavioral: Motivational interviewing |
| Motivational interviewing to patients and caregivers | Experimental | In this arm the interventions will be delivered both to patients and caregivers Receives: Behavioral: Motivational interviewing |
| Control group | No intervention | This Group will receive the usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-care Maintenance in Patients
Self-care in HF patients will be measured with the Self-Care of HF Index V.6.2. Since this instrument has three separate scales, we considered as a primary outcome the score of the Self-care Maintenance scale. The Self-Care Maintenance scale has a score between 0 and 100 with higher score meaning better self-care. Self-Care Maintenance is considered adequate when the score is at least 70.
Measured: 3 months from the intervention
Secondary outcomes (11)
Burden of HF Symptoms in Patients
Burden of HF symptoms will be measured with the Heart Failure Somatic Perception Scale (HFSPS). The HFSPS has a range score between 0 and 90; the higher the score, the higher the burden of symptoms caused by heart failure.
Measured: 3, 6, 9 and 12 months from the intervention
Patient and Caregiver Generic Physical and Mental Quality of Life
Patient and caregiver generic physical and mental quality of life will be assessed with the Short Form 12 (SF-12).
Measured: 3, 6, 9 and 12 months from the intervention
Patient and Caregiver Anxiety and Depression
Patient and caregiver anxiety and depression will be evaluated with the Hospital Anxiety and Depression Scale
Measured: 3, 6, 9 and 12 months from the intervention
Patient HF Specific Quality of Life
Patient HF specific quality of life will be evaluated with the Kansas City Cardiomyopathy Questionnaire
Measured: 3, 6, 9 and 12 months from the intervention
Patient and Caregiver Quality of Nocturnal Sleep
We will use the Pittsburgh Sleep Quality Index
Measured: 3, 6, 9 and 12 months from the intervention
Patient and Caregiver Mutuality
We will use the Mutuality Scale
Measured: 3, 6, 9 and 12 months from the intervention
Caregiver Preparedness
Caregiver Preparedness will be evaluated with the Caregiver Preparedness Scale
Measured: 3, 6, 9 and 12 months from the intervention
Caregiver Perceived Social Support
We will use the Multidimensional Scale of Perceived Social Support Scale
Measured: 3, 6, 9 and 12 months from the intervention
Patient Hospitalizations
The number of patient hospitalizations will be measured asking the caregiver how many time the patient was hospitalized from at 3, 6, 9 and 12 months from the intervention.
Measured: 3, 6, 9 and 12 months from the intervention
Use of Emergency Services
How many times the patient has used the emergency services will be evaluated by asking the caregiver how many time the patient used after 3, 6, 9 and 12 months from the intervention.
Measured: 3, 6, 9 and 12 months from the intervention
Death
Death rates will be evaluated in the three arms of the study by caregiver interview at 3, 6, 9 and 12 months from the intervention.
Measured: 3, 6, 9 and 12 months from the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startJun 2014
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- 510 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Collaborators
- Center of Excellence for Nursing Scholarship
- Responsible party
- Principal investigator, Ercole Vellone, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894502
- Sponsor's protocol ID
- 121/13
- Acronym
- MOTIVATE-HF
- Status last verified
- Feb 2021
- First submitted
- 26 Aug 2016
- Last updated
- 17 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: In case there will be the possibility to share the data, this will be done after data de-identification
Publications
Vellone E, Paturzo M, D'Agostino F, Petruzzo A, Masci S, Ausili D, Rebora P, Alvaro R, Riegel B. MOTIVATional intErviewing to improve self-care in Heart Failure patients (MOTIVATE-HF): Study protocol of a three-arm multicenter randomized controlled trial. Contemp Clin Trials. 2017 Apr;55:34-38. doi: 10.1016/j.cct.2017.02.003. Epub 2017 Feb 7.
PubMed 28185994Vellone E, Rebora P, Ausili D, Zeffiro V, Pucciarelli G, Caggianelli G, Masci S, Alvaro R, Riegel B. Motivational interviewing to improve self-care in heart failure patients (MOTIVATE-HF): a randomized controlled trial. ESC Heart Fail. 2020 Jun;7(3):1309-1318. doi: 10.1002/ehf2.12733. Epub 2020 Apr 28.
PubMed 32343483Vellone E, Iovino P, Torreggiani M, Pucciarelli G, Zeffiro V, Scerbo F, Uchmanowicz I, Micheluzzi V. Ejection fraction moderates the effect of motivational interviewing in improving heart failure self-care: a secondary analysis of the MOTIVATE-HF randomized controlled trial. Eur J Cardiovasc Nurs. 2026 Jul 31:zvag161. doi: 10.1093/eurjcn/zvag161. Online ahead of print.
PubMed 42536400Iovino P, Dollaku H, Alvaro R, Pucciarelli G, Rasero L, Macchi C, Liuzzi P, Riegel B, Vellone E. Sleep quality patterns in patients with heart failure: a person-centred latent class analysis from a secondary analysis of the MOTIVATE-HF trial. BMJ Open. 2025 Aug 8;15(8):e101950. doi: 10.1136/bmjopen-2025-101950.
PubMed 40780724Iovino P, Dollaku H, Rasero L, Uchmanowicz I, Alvaro R, Pucciarelli G, Vellone E. Psychometric Testing of the Kansas City Cardiomyopathy Questionnaire 12 in A European Population. J Cardiovasc Nurs. 2025 Feb 27;40(6):E374-82. doi: 10.1097/JCN.0000000000001187. Online ahead of print.
PubMed 40013908Caggianelli G, Alivernini F, Chirico A, Iovino P, Lucidi F, Uchmanowicz I, Rasero L, Alvaro R, Vellone E. The relationship between caregiver contribution to self-care and patient quality of life in heart failure: A longitudinal mediation analysis. PLoS One. 2024 Mar 12;19(3):e0300101. doi: 10.1371/journal.pone.0300101. eCollection 2024.
PubMed 38470867Locatelli G, Iovino P, Jurgens CY, Alvaro R, Uchmanowicz I, Rasero L, Riegel B, Vellone E. The Influence of Caregiver Contribution to Self-care on Symptom Burden in Patients With Heart Failure and the Mediating Role of Patient Self-care: A Longitudinal Mediation Analysis. J Cardiovasc Nurs. 2024 May-Jun 01;39(3):255-265. doi: 10.1097/JCN.0000000000001024. Epub 2023 Aug 8.
PubMed 37550831Locatelli G, Rebora P, Occhino G, Ausili D, Riegel B, Cammarano A, Uchmanowicz I, Alvaro R, Vellone E, Zeffiro V. The Impact of an Intervention to Improve Caregiver Contribution to Heart Failure Self-care on Caregiver Anxiety, Depression, Quality of Life, and Sleep. J Cardiovasc Nurs. 2023 May 18;38(4):361-9. doi: 10.1097/JCN.0000000000000998. Online ahead of print.
PubMed 37204336Spedale V, Fabrizi D, Rebora P, Luciani M, Alvaro R, Vellone E, Riegel B, Ausili D. The Association Between Self-reported Sleep Quality and Self-care in Adults With Heart Failure: A Cross-sectional Study. J Cardiovasc Nurs. 2023 May-Jun 01;38(3):E98-E109. doi: 10.1097/JCN.0000000000000929. Epub 2022 May 31.
PubMed 37027137Locatelli G, Zeffiro V, Occhino G, Rebora P, Caggianelli G, Ausili D, Alvaro R, Riegel B, Vellone E. Effectiveness of Motivational Interviewing on contribution to self-care, self-efficacy, and preparedness in caregivers of patients with heart failure: a secondary outcome analysis of the MOTIVATE-HF randomized controlled trial. Eur J Cardiovasc Nurs. 2022 Nov 23;21(8):801-811. doi: 10.1093/eurjcn/zvac013.
PubMed 35290454Caggianelli G, Iovino P, Rebora P, Occhino G, Zeffiro V, Locatelli G, Ausili D, Alvaro R, Riegel B, Vellone E. A Motivational Interviewing Intervention Improves Physical Symptoms in Patients with Heart Failure: A Secondary Outcome Analysis of the Motivate-HF Randomized Controlled Trial. J Pain Symptom Manage. 2022 Feb;63(2):221-229.e1. doi: 10.1016/j.jpainsymman.2021.09.006. Epub 2021 Sep 25.
PubMed 34571194Rebora P, Spedale V, Occhino G, Luciani M, Alvaro R, Vellone E, Riegel B, Ausili D. Effectiveness of motivational interviewing on anxiety, depression, sleep quality and quality of life in heart failure patients: secondary analysis of the MOTIVATE-HF randomized controlled trial. Qual Life Res. 2021 Jul;30(7):1939-1949. doi: 10.1007/s11136-021-02788-3. Epub 2021 Feb 22.
PubMed 33616815
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients (MOTIVATE-HF): Study Protocol of a Three-arm Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02894502
- Acronym / sponsor ID
- MOTIVATE-HF / 121/13
- Conditions
- Heart Failure
- Keywords
- Self-care, Motivational interviewing, Heart failure, Caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 510 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Collaborators
- Center of Excellence for Nursing Scholarship
- Study start
- Jun 2014
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Posted 24 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of this study will be to evaluate the effect of motivational interviewing (MI) to improve self-care in heart failure (HF) patients and caregiver contributions to HF self-care. Also this study will evaluate the effect of MI on the following secondary outcomes: In HF patients: HF somatic symptom perception, generic and specific quality of life, anxiety and depression, sleep quality, mutuality with caregiver, hospitalizations, use of emergency services, and mortality; In caregivers: generic quality of life, anxiety and depression, mutuality with patient, preparedness, social support and sleep quality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motivational interviewing only for patients | Experimental | Behavioral: Motivational interviewingIn this arm the interventions will be delivered only to patients |
| Motivational interviewing to patients and caregivers | Experimental | Behavioral: Motivational interviewingIn this arm the interventions will be delivered both to patients and caregivers |
| Control group | No intervention | –This Group will receive the usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of HF (for patient), New York Heart Association (NYHA) functional class II- IV (for patient), Inadequate self-care assessed with the Self-Care Heart Failure Index (for patient), Being the informal caregiver of the patients (for caregiver).
Key exclusion criteria (1 listed)
- Severe cognitive impairment evaluated with the Six-item screener (for patient), Acute coronary syndrome during the last three months (for patient), Living in a residential settings (e.g., nursing home) (for patient), Patients not willing to participate in the study (for caregiver).
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 |
|---|---|---|
| Motivational interviewingThe intervention will consist of a brief session of motivational interviewing (MI) performed by a trained nurse. During MI, the interventionist will address one or two aspects of self-care that the participants want to address. After this first intervention, the same interventionist will contact the participant by telephone to improve the first intervention and provide further support as needed. These telephone contact will be done three times at two week intervals following the first intervention (for a total of two months). Patients and caregivers that receive the intervention also will be given informational material on HF management that is consistent with international guidelines. | Behavioural | Motivational interviewing only for patients, Motivational interviewing to patients and caregivers |
Primary outcome
Self-care Maintenance in Patients
Time frame: 3 months from the intervention
Self-care in HF patients will be measured with the Self-Care of HF Index V.6.2. Since this instrument has three separate scales, we considered as a primary outcome the score of the Self-care Maintenance scale. The Self-Care Maintenance scale has a score between 0 and 100 with higher score meaning better self-care. Self-Care Maintenance is considered adequate when the score is at least 70.
11 secondary outcomes
Burden of HF Symptoms in Patients
Time frame: 3, 6, 9 and 12 months from the intervention
Patient and Caregiver Generic Physical and Mental Quality of Life
Time frame: 3, 6, 9 and 12 months from the intervention
Patient and Caregiver Anxiety and Depression
Time frame: 3, 6, 9 and 12 months from the intervention
Patient HF Specific Quality of Life
Time frame: 3, 6, 9 and 12 months from the intervention
Patient and Caregiver Quality of Nocturnal Sleep
Time frame: 3, 6, 9 and 12 months from the intervention
Patient and Caregiver Mutuality
Time frame: 3, 6, 9 and 12 months from the intervention
Caregiver Preparedness
Time frame: 3, 6, 9 and 12 months from the intervention
Caregiver Perceived Social Support
Time frame: 3, 6, 9 and 12 months from the intervention
Patient Hospitalizations
Time frame: 3, 6, 9 and 12 months from the intervention
Use of Emergency Services
Time frame: 3, 6, 9 and 12 months from the intervention
Death
Time frame: 3, 6, 9 and 12 months from the intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28185994Vellone E, Paturzo M, D'Agostino F, Petruzzo A, Masci S, Ausili D, Rebora P, Alvaro R, Riegel B. MOTIVATional intErviewing to improve self-care in Heart Failure patients (MOTIVATE-HF): Study protocol of a three-arm multicenter randomized controlled trial. Contemp Clin Trials. 2017 Apr;55:34-38. doi: 10.1016/j.cct.2017.02.003. Epub 2017 Feb 7.
- Results publication: PubMed 32343483Vellone E, Rebora P, Ausili D, Zeffiro V, Pucciarelli G, Caggianelli G, Masci S, Alvaro R, Riegel B. Motivational interviewing to improve self-care in heart failure patients (MOTIVATE-HF): a randomized controlled trial. ESC Heart Fail. 2020 Jun;7(3):1309-1318. doi: 10.1002/ehf2.12733. Epub 2020 Apr 28.
- Derived from this study: PubMed 42536400Vellone E, Iovino P, Torreggiani M, Pucciarelli G, Zeffiro V, Scerbo F, Uchmanowicz I, Micheluzzi V. Ejection fraction moderates the effect of motivational interviewing in improving heart failure self-care: a secondary analysis of the MOTIVATE-HF randomized controlled trial. Eur J Cardiovasc Nurs. 2026 Jul 31:zvag161. doi: 10.1093/eurjcn/zvag161. Online ahead of print.
- Derived from this study: PubMed 40780724Iovino P, Dollaku H, Alvaro R, Pucciarelli G, Rasero L, Macchi C, Liuzzi P, Riegel B, Vellone E. Sleep quality patterns in patients with heart failure: a person-centred latent class analysis from a secondary analysis of the MOTIVATE-HF trial. BMJ Open. 2025 Aug 8;15(8):e101950. doi: 10.1136/bmjopen-2025-101950.
- Derived from this study: PubMed 40013908Iovino P, Dollaku H, Rasero L, Uchmanowicz I, Alvaro R, Pucciarelli G, Vellone E. Psychometric Testing of the Kansas City Cardiomyopathy Questionnaire 12 in A European Population. J Cardiovasc Nurs. 2025 Feb 27;40(6):E374-82. doi: 10.1097/JCN.0000000000001187. Online ahead of print.
- Derived from this study: PubMed 38470867Caggianelli G, Alivernini F, Chirico A, Iovino P, Lucidi F, Uchmanowicz I, Rasero L, Alvaro R, Vellone E. The relationship between caregiver contribution to self-care and patient quality of life in heart failure: A longitudinal mediation analysis. PLoS One. 2024 Mar 12;19(3):e0300101. doi: 10.1371/journal.pone.0300101. eCollection 2024.
- Derived from this study: PubMed 37550831Locatelli G, Iovino P, Jurgens CY, Alvaro R, Uchmanowicz I, Rasero L, Riegel B, Vellone E. The Influence of Caregiver Contribution to Self-care on Symptom Burden in Patients With Heart Failure and the Mediating Role of Patient Self-care: A Longitudinal Mediation Analysis. J Cardiovasc Nurs. 2024 May-Jun 01;39(3):255-265. doi: 10.1097/JCN.0000000000001024. Epub 2023 Aug 8.
- Derived from this study: PubMed 37204336Locatelli G, Rebora P, Occhino G, Ausili D, Riegel B, Cammarano A, Uchmanowicz I, Alvaro R, Vellone E, Zeffiro V. The Impact of an Intervention to Improve Caregiver Contribution to Heart Failure Self-care on Caregiver Anxiety, Depression, Quality of Life, and Sleep. J Cardiovasc Nurs. 2023 May 18;38(4):361-9. doi: 10.1097/JCN.0000000000000998. Online ahead of print.
- Derived from this study: PubMed 37027137Spedale V, Fabrizi D, Rebora P, Luciani M, Alvaro R, Vellone E, Riegel B, Ausili D. The Association Between Self-reported Sleep Quality and Self-care in Adults With Heart Failure: A Cross-sectional Study. J Cardiovasc Nurs. 2023 May-Jun 01;38(3):E98-E109. doi: 10.1097/JCN.0000000000000929. Epub 2022 May 31.
- Derived from this study: PubMed 35290454Locatelli G, Zeffiro V, Occhino G, Rebora P, Caggianelli G, Ausili D, Alvaro R, Riegel B, Vellone E. Effectiveness of Motivational Interviewing on contribution to self-care, self-efficacy, and preparedness in caregivers of patients with heart failure: a secondary outcome analysis of the MOTIVATE-HF randomized controlled trial. Eur J Cardiovasc Nurs. 2022 Nov 23;21(8):801-811. doi: 10.1093/eurjcn/zvac013.
- Derived from this study: PubMed 34571194Caggianelli G, Iovino P, Rebora P, Occhino G, Zeffiro V, Locatelli G, Ausili D, Alvaro R, Riegel B, Vellone E. A Motivational Interviewing Intervention Improves Physical Symptoms in Patients with Heart Failure: A Secondary Outcome Analysis of the Motivate-HF Randomized Controlled Trial. J Pain Symptom Manage. 2022 Feb;63(2):221-229.e1. doi: 10.1016/j.jpainsymman.2021.09.006. Epub 2021 Sep 25.
- Derived from this study: PubMed 33616815Rebora P, Spedale V, Occhino G, Luciani M, Alvaro R, Vellone E, Riegel B, Ausili D. Effectiveness of motivational interviewing on anxiety, depression, sleep quality and quality of life in heart failure patients: secondary analysis of the MOTIVATE-HF randomized controlled trial. Qual Life Res. 2021 Jul;30(7):1939-1949. doi: 10.1007/s11136-021-02788-3. Epub 2021 Feb 22.
- Individual participant dataSharing planned: Yes. In case there will be the possibility to share the data, this will be done after data de-identification
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing in people with Heart Failure, run by University of Rome Tor Vergata 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 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 17 Mar 2021. 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?
Yes. Results are posted in the registry (first posted 24 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self-care Maintenance in Patients (time frame: 3 months from the intervention). 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 NCT02894502, which also lists 12 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 17 Mar 2021.