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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Motivational Interviewing Only for Patients Motivational Interviewing to Patients and Caregivers Control Group
Hide 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
Arm/Group Title Motivational Interviewing Only for Patients Motivational Interviewing to Patients and Caregivers Control Group Total
Hide 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
Hide 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.
1.Primary Outcome
Title Self-care Maintenance in Patients
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Motivational Interviewing Only for Patients Motivational Interviewing to Patients and Caregivers Control Group
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with heart failure
Arm/Group Title Motivational Interviewing Only for Patients Motivational Interviewing for Patients and Caregivers Control Group
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
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
Hide 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%) 
Hide 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 
Hide 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 
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
Layout table for Results Point of Contact information
Name/Title: Dr. Ercole Vellone
Organization: University of Rome Tor vergata, Rome, Italy
Phone: +393387491811
EMail: ercole.vellone@uniroma2.it
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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