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| Name | Class |
|---|---|
| Center of Excellence for Nursing Scholarship | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivational interviewing only for patients | Experimental | In this arm the interventions will be delivered only to patients |
|
| Motivational interviewing to patients and caregivers | Experimental | In this arm the interventions will be delivered both to patients and caregivers |
|
| Control group | No Intervention | This Group will receive the usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational interviewing | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months from the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3, 6, 9 and 12 months from the intervention |
| Patient and Caregiver Generic Physical and Mental Quality of Life |
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Inclusion criteria:
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).
Exclusion criteria:
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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rome Tor Vergata | Rome | 00135 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28185994 | Background | 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. | |
| 32343483 |
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In case there will be the possibility to share the data, this will be done after data de-identification
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| ID | Title | Description |
|---|---|---|
| FG000 | Motivational Interviewing Only for Patients | In this arm the interventions will be delivered only to patients Motivational interviewing: 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. |
| FG001 | Motivational Interviewing to Patients and Caregivers | In this arm the interventions will be delivered both to patients and caregivers Motivational interviewing: 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. |
| FG002 | Control Group | This Group will receive the usual care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| First Follow up |
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| Second Follow up |
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| Third Follow up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Motivational Interviewing Only for Patients | In this arm the interventions will be delivered only to patients Motivational interviewing: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | In the "Motivational interviewing only for patients" and in the "Control group" Arms we have missing data. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months from the intervention |
|
one year
In this study we considered only all-cause mortality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Motivational Interviewing Only for Patients | In this arm the interventions will be delivered only to patients Motivational interviewing: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ercole Vellone | University of Rome Tor vergata, Rome, Italy | +393387491811 | ercole.vellone@uniroma2.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 9, 2018 | Dec 10, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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|
Patient and caregiver generic physical and mental quality of life will be assessed with the Short Form 12 (SF-12). |
| 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 | 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 | 3, 6, 9 and 12 months from the intervention |
| Patient and Caregiver Quality of Nocturnal Sleep | We will use the Pittsburgh Sleep Quality Index | 3, 6, 9 and 12 months from the intervention |
| Patient and Caregiver Mutuality | We will use the Mutuality Scale | 3, 6, 9 and 12 months from the intervention |
| Caregiver Preparedness | Caregiver Preparedness will be evaluated with the Caregiver Preparedness Scale | 3, 6, 9 and 12 months from the intervention |
| Caregiver Perceived Social Support | We will use the Multidimensional Scale of Perceived Social Support Scale | 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. | 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. | 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. | 3, 6, 9 and 12 months from the intervention |
| Vellone 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. |
| 40780724 | Derived | Iovino 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. |
| 40013908 | Derived | Iovino 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. |
| 38470867 | Derived | Caggianelli 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. |
| 37550831 | Derived | Locatelli 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. |
| 37204336 | Derived | Locatelli 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. |
| 37027137 | Derived | Spedale 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. |
| 35290454 | Derived | Locatelli 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. |
| 34571194 | Derived | Caggianelli 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. |
| 33616815 | Derived | Rebora 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. |
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| BG001 | Motivational Interviewing to Patients and Caregivers | In this arm the interventions will be delivered both to patients and caregivers Motivational interviewing: 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. |
| BG002 | Control Group | This Group will receive the usual care |
| BG003 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | In the first and in the third arm we have missing data | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Self-Care of Heart Failure Index | Score of the Self-Care Maintenance Scale of the Self-Care of Heart Failure Index (SCHFI) (primary endpoint). The SCHFI has three scales: Self-Care Maintenance, Self-Care Management and Self-Care Confidence. Each scale has a score from 0 to 100 with higher score meaning better self-care. Self-Care is considered adequate when patients have a score at each scale of 70 at least. | Mean | Standard Deviation | units on a scale |
|
| Heart Failure Somatic Perception Scale | The Heart Failure Somatic Perception Scale has a score between 0 and 90 with higher scores meaning more discomfort caused by heart failure symptoms | Mean | Standard Deviation | units on a scale |
|
| SF-12 (Physical Component Summary) | The SF-12 (Physical Component Summary) measures the physical aspects of health-related quality of life. The score ranges between 0 and 100 with higher score indicating better quality of life. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Motivational Interviewing to Patients and Caregivers | In this arm the interventions will be delivered both to patients and caregivers Motivational interviewing: 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. |
| OG002 | Control Group | This Group will receive the usual care |
|
|
| Secondary | 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. | Patients with heart failure | Posted | Mean | Standard Deviation | score on a scale | 3, 6, 9 and 12 months from the intervention |
|
|
|
| Secondary | 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). | Not Posted | 3, 6, 9 and 12 months from the intervention | Participants |
| Secondary | Patient and Caregiver Anxiety and Depression | Patient and caregiver anxiety and depression will be evaluated with the Hospital Anxiety and Depression Scale | Not Posted | 3, 6, 9 and 12 months from the intervention | Participants |
| Secondary | Patient HF Specific Quality of Life | Patient HF specific quality of life will be evaluated with the Kansas City Cardiomyopathy Questionnaire | Not Posted | 3, 6, 9 and 12 months from the intervention | Participants |
| Secondary | Patient and Caregiver Quality of Nocturnal Sleep | We will use the Pittsburgh Sleep Quality Index | Not Posted | 3, 6, 9 and 12 months from the intervention | Participants |
| Secondary | Patient and Caregiver Mutuality | We will use the Mutuality Scale | Not Posted | 3, 6, 9 and 12 months from the intervention | Participants |
| Secondary | Caregiver Preparedness | Caregiver Preparedness will be evaluated with the Caregiver Preparedness Scale | Not Posted | 3, 6, 9 and 12 months from the intervention | Participants |
| Secondary | Caregiver Perceived Social Support | We will use the Multidimensional Scale of Perceived Social Support Scale | Not Posted | 3, 6, 9 and 12 months from the intervention | Participants |
| Secondary | 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. | Not Posted | 3, 6, 9 and 12 months from the intervention | Participants |
| Secondary | 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. | Not Posted | 3, 6, 9 and 12 months from the intervention | Participants |
| Secondary | 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. | The above participants were those who were randomized initially in the three arms. | Posted | Count of Participants | Participants | No | 3, 6, 9 and 12 months from the intervention |
|
|
|
| 8 |
| 155 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Motivational Interviewing to Patients and Caregivers | In this arm the interventions will be delivered both to patients and caregivers Motivational interviewing: 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. | 7 | 177 | 0 | 0 | 0 | 0 |
| EG002 | Control Group | This Group will receive the usual care | 13 | 178 | 0 | 0 | 0 | 0 |
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| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| Between 18 and 65 years |
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| >=65 years |
|
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Number of refusals to continue the study |
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| 6 month follow-up |
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| 9 month follow-up |
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| 12 month follow-up |
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