MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients (MOTIVATE-HF)

• ClinicalTrials.gov Identifier: NCT02894502
• Recruitment Status: Completed
• First Posted: September 9, 2016
• Results First Posted: February 24, 2021
• Last Update Posted: March 17, 2021
• Sponsor: University of Rome Tor Vergata
• Collaborator: Center of Excellence for Nursing Scholarship, Rome, Italy
• Information provided by (Responsible Party): Ercole Vellone, University of Rome Tor Vergata

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Supportive Care
• Condition: Heart Failure
• Intervention: Behavioral: Motivational interviewing
• Enrollment: 510

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Motivational Interviewing Only for Patients	Motivational Interviewing to Patients and Caregivers	Control Group
Arm/Group Description	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.	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.	This Group will receive the usual care
Period Title: Baseline
Started	155	177	178
Completed	128	145	133
Not Completed	27	32	45
Reason Not Completed
Withdrawal by Subject	24	31	36
Death	3	1	9
Period Title: First Follow up
Started	128	145	133
Completed	94	114	93
Not Completed	34	31	40
Reason Not Completed
Withdrawal by Subject	32	29	37
Death	2	2	3
Period Title: Second Follow up
Started	94	114	93
Completed	79	96	79
Not Completed	15	18	14
Reason Not Completed
Withdrawal by Subject	13	15	13
Death	2	3	1
Period Title: Third Follow up
Started	79	96	79
Completed	73	89	76
Not Completed	6	7	3
Reason Not Completed
Withdrawal by Subject	5	6	3
Death	1	1	0

Baseline Characteristics

Arm/Group Title		Motivational Interviewing Only for Patients	Motivational Interviewing to Patients and Caregivers	Control Group	Total
Arm/Group Description		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.	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.	This Group will receive the usual care	Total of all reporting groups
Overall Number of Baseline Participants		155	177	178	510
Baseline Analysis Population Description		[Not Specified]
Age, Categorical [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	154 participants	177 participants	177 participants	508 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	35 22.7%	45 25.4%	47 26.6%	127 25.0%
	>=65 years	119 77.3%	132 74.6%	130 73.4%	381 75.0%
		[1] Measure Analysis Population Description: In the "Motivational interviewing only for patients" and in the "Control group" Arms we have missing data.
Age, Continuous [1]; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	154 participants	177 participants	177 participants	508 participants
		72.19 (12.29)	72.45 (10.79)	72.45 (13.66)	72.37 (12.28)
		[1] Measure Analysis Population Description: In the first and in the third arm we have missing data
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	155 participants	177 participants	178 participants	510 participants
	Female	75 48.4%	70 39.5%	69 38.8%	214 42.0%
	Male	80 51.6%	107 60.5%	109 61.2%	296 58.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	155 participants	177 participants	178 participants	510 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	White	155 100.0%	177 100.0%	178 100.0%	510 100.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Self-Care of Heart Failure Index [1]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	155 participants	177 participants	178 participants	510 participants
		45.72 (15.23)	45.98 (16.35)	44.98 (14.61)	45.55 (15.39)
		[1] Measure Description: 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.
Heart Failure Somatic Perception Scale [1]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	155 participants	177 participants	178 participants	510 participants
		30.55 (18.20)	30.18 (18.25)	31.83 (18.95)	30.87 (18.46)
		[1] Measure Description: The Heart Failure Somatic Perception Scale has a score between 0 and 90 with higher scores meaning more discomfort caused by heart failure symptoms
SF-12 (Physical Component Summary) [1]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	155 participants	177 participants	178 participants	510 participants
		36.01 (10.35)	35.01 (9.16)	35.42 (9.30)	35.46 (9.57)
		[1] Measure Description: 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.

Outcome Measures

1. Primary Outcome

Title	Self-care Maintenance in Patients
Description	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.
Time Frame	3 months from the intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Motivational Interviewing Only for Patients	Motivational Interviewing to Patients and Caregivers	Control Group
Arm/Group Description:	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.	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.	This Group will receive the usual care
Overall Number of Participants Analyzed	128	145	133
Mean (Standard Deviation); Unit of Measure: score on a scale
	52.36 (22.67)	54.23 (20.36)	49.63 (17.49)

2. Secondary Outcome

Title	Burden of HF Symptoms in Patients
Description	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.
Time Frame	3, 6, 9 and 12 months from the intervention

Outcome Measure Data

Analysis Population Description

Patients with heart failure

Arm/Group Title	Motivational Interviewing Only for Patients	Motivational Interviewing for Patients and Caregivers	Control Group
Arm/Group Description:	In this Arm, motivational interviewing will be provided only to patients	In this Arm, motivational interviewing will be provided to patients and caregivers	This Arm will receive the standard of care
Overall Number of Participants Analyzed	73	89	76
Mean (Standard Deviation); Unit of Measure: score on a scale
	24 (16.5)	17.4 (18.8)	22.5 (21.7)

3. Secondary Outcome

Title	Patient and Caregiver Generic Physical and Mental Quality of Life
Description	Patient and caregiver generic physical and mental quality of life will be assessed with the Short Form 12 (SF-12).
Time Frame	3, 6, 9 and 12 months from the intervention

Outcome Measure Data Not Reported

4. Secondary Outcome

Title	Patient and Caregiver Anxiety and Depression
Description	Patient and caregiver anxiety and depression will be evaluated with the Hospital Anxiety and Depression Scale
Time Frame	3, 6, 9 and 12 months from the intervention

Outcome Measure Data Not Reported

5. Secondary Outcome

Title	Patient HF Specific Quality of Life
Description	Patient HF specific quality of life will be evaluated with the Kansas City Cardiomyopathy Questionnaire
Time Frame	3, 6, 9 and 12 months from the intervention

Outcome Measure Data Not Reported

6. Secondary Outcome

Title	Patient and Caregiver Quality of Nocturnal Sleep
Description	We will use the Pittsburgh Sleep Quality Index
Time Frame	3, 6, 9 and 12 months from the intervention

Outcome Measure Data Not Reported

7. Secondary Outcome

Title	Patient and Caregiver Mutuality
Description	We will use the Mutuality Scale
Time Frame	3, 6, 9 and 12 months from the intervention

Outcome Measure Data Not Reported

8. Secondary Outcome

Title	Caregiver Preparedness
Description	Caregiver Preparedness will be evaluated with the Caregiver Preparedness Scale
Time Frame	3, 6, 9 and 12 months from the intervention

Outcome Measure Data Not Reported

9. Secondary Outcome

Title	Caregiver Perceived Social Support
Description	We will use the Multidimensional Scale of Perceived Social Support Scale
Time Frame	3, 6, 9 and 12 months from the intervention

Outcome Measure Data Not Reported

10. Secondary Outcome

Title	Patient Hospitalizations
Description	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.
Time Frame	3, 6, 9 and 12 months from the intervention

Outcome Measure Data Not Reported

11. Secondary Outcome

Title	Use of Emergency Services
Description	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.
Time Frame	3, 6, 9 and 12 months from the intervention

Outcome Measure Data Not Reported

12. Secondary Outcome

Title	Death
Description	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.
Time Frame	3, 6, 9 and 12 months from the intervention

Outcome Measure Data

Analysis Population Description

The above participants were those who were randomized initially in the three arms.

Arm/Group Title		Motivational Interviewing Only for Patients	Motivational Interviewing to Patients and Caregivers	Control Group
Arm/Group Description:		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.	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.	This Group will receive the usual care
Overall Number of Participants Analyzed		155	177	178
Measure Type: Count of Participants; Unit of Measure: Participants
3 month follow-up	Overall Number of Participants Analyzed	128	145	133
	Number of Deaths	3	1	9
	Number of refusals to continue the study	24	31	36
6 month follow-up	Overall Number of Participants Analyzed	94	114	93
	Number of Deaths	5	3	12
	Number of refusals to continue the study	56	60	73
9 month follow-up	Overall Number of Participants Analyzed	79	96	79
	Number of Deaths	7	6	13
	Number of refusals to continue the study	69	75	86
12 month follow-up	Overall Number of Participants Analyzed	73	89	76
	Number of Deaths	8	7	13
	Number of refusals to continue the study	74	81	89

Adverse Events

Time Frame	one year
Adverse Event Reporting Description	In this study we considered only all-cause mortality.
Arm/Group Title	Motivational Interviewing Only for Patients	Motivational Interviewing to Patients and Caregivers	Control Group
Arm/Group Description	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.	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.	This Group will receive the usual care
All-Cause Mortality
	Motivational Interviewing Only for Patients	Motivational Interviewing to Patients and Caregivers	Control Group
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	8/155 (5.16%)	7/177 (3.95%)	13/178 (7.30%)
Serious Adverse Events
	Motivational Interviewing Only for Patients	Motivational Interviewing to Patients and Caregivers	Control Group
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0	0/0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Motivational Interviewing Only for Patients	Motivational Interviewing to Patients and Caregivers	Control Group
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0	0/0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Ercole Vellone
• Organization: University of Rome Tor vergata, Rome, Italy
• Phone: +393387491811
• EMail: ercole.vellone@uniroma2.it

Publications of Results:

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.

Other 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. 2022 May 31. doi: 10.1097/JCN.0000000000000929. Online ahead of print.

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.

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.

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.

• Responsible Party: Ercole Vellone, University of Rome Tor Vergata
• ClinicalTrials.gov Identifier: NCT02894502
• Other Study ID Numbers: 121/13
• First Submitted: August 26, 2016
• First Posted: September 9, 2016
• Results First Submitted: November 3, 2020
• Results First Posted: February 24, 2021
• Last Update Posted: March 17, 2021