Trial Outcomes & Findings for MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients (NCT NCT02894502)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

510 participants

Primary outcome timeframe

3 months from the intervention

Results posted on

2021-03-17

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	Control Group This Group will receive the usual care
Baseline STARTED	155	177	178
Baseline COMPLETED	128	145	133
Baseline NOT COMPLETED	27	32	45
First Follow up STARTED	128	145	133
First Follow up COMPLETED	94	114	93
First Follow up NOT COMPLETED	34	31	40
Second Follow up STARTED	94	114	93
Second Follow up COMPLETED	79	96	79
Second Follow up NOT COMPLETED	15	18	14
Third Follow up STARTED	79	96	79
Third Follow up COMPLETED	73	89	76
Third Follow up NOT COMPLETED	6	7	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	Control Group This Group will receive the usual care
Baseline Withdrawal by Subject	24	31	36
Baseline Death	3	1	9
First Follow up Withdrawal by Subject	32	29	37
First Follow up Death	2	2	3
Second Follow up Withdrawal by Subject	13	15	13
Second Follow up Death	2	3	1
Third Follow up Withdrawal by Subject	5	6	3
Third Follow up Death	1	1	0

Baseline Characteristics

In the "Motivational interviewing only for patients" and in the "Control group" Arms we have missing data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Motivational Interviewing Only for Patients n=155 Participants 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.	Motivational Interviewing to Patients and Caregivers n=177 Participants 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.	Control Group n=178 Participants This Group will receive the usual care	Total n=510 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=154 Participants • In the "Motivational interviewing only for patients" and in the "Control group" Arms we have missing data.	0 Participants n=177 Participants • In the "Motivational interviewing only for patients" and in the "Control group" Arms we have missing data.	0 Participants n=177 Participants • In the "Motivational interviewing only for patients" and in the "Control group" Arms we have missing data.	0 Participants n=508 Participants • In the "Motivational interviewing only for patients" and in the "Control group" Arms we have missing data.
Age, Categorical Between 18 and 65 years	35 Participants n=154 Participants • In the "Motivational interviewing only for patients" and in the "Control group" Arms we have missing data.	45 Participants n=177 Participants • In the "Motivational interviewing only for patients" and in the "Control group" Arms we have missing data.	47 Participants n=177 Participants • In the "Motivational interviewing only for patients" and in the "Control group" Arms we have missing data.	127 Participants n=508 Participants • In the "Motivational interviewing only for patients" and in the "Control group" Arms we have missing data.
Age, Categorical >=65 years	119 Participants n=154 Participants • In the "Motivational interviewing only for patients" and in the "Control group" Arms we have missing data.	132 Participants n=177 Participants • In the "Motivational interviewing only for patients" and in the "Control group" Arms we have missing data.	130 Participants n=177 Participants • In the "Motivational interviewing only for patients" and in the "Control group" Arms we have missing data.	381 Participants n=508 Participants • In the "Motivational interviewing only for patients" and in the "Control group" Arms we have missing data.
Age, Continuous	72.19 Years STANDARD_DEVIATION 12.29 • n=154 Participants • In the first and in the third arm we have missing data	72.45 Years STANDARD_DEVIATION 10.79 • n=177 Participants • In the first and in the third arm we have missing data	72.45 Years STANDARD_DEVIATION 13.66 • n=177 Participants • In the first and in the third arm we have missing data	72.37 Years STANDARD_DEVIATION 12.28 • n=508 Participants • In the first and in the third arm we have missing data
Sex: Female, Male Female	75 Participants n=155 Participants	70 Participants n=177 Participants	69 Participants n=178 Participants	214 Participants n=510 Participants
Sex: Female, Male Male	80 Participants n=155 Participants	107 Participants n=177 Participants	109 Participants n=178 Participants	296 Participants n=510 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=155 Participants	0 Participants n=177 Participants	0 Participants n=178 Participants	0 Participants n=510 Participants
Race (NIH/OMB) Asian	0 Participants n=155 Participants	0 Participants n=177 Participants	0 Participants n=178 Participants	0 Participants n=510 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=155 Participants	0 Participants n=177 Participants	0 Participants n=178 Participants	0 Participants n=510 Participants
Race (NIH/OMB) Black or African American	0 Participants n=155 Participants	0 Participants n=177 Participants	0 Participants n=178 Participants	0 Participants n=510 Participants
Race (NIH/OMB) White	155 Participants n=155 Participants	177 Participants n=177 Participants	178 Participants n=178 Participants	510 Participants n=510 Participants
Race (NIH/OMB) More than one race	0 Participants n=155 Participants	0 Participants n=177 Participants	0 Participants n=178 Participants	0 Participants n=510 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=155 Participants	0 Participants n=177 Participants	0 Participants n=178 Participants	0 Participants n=510 Participants
Self-Care of Heart Failure Index	45.72 units on a scale STANDARD_DEVIATION 15.23 • n=155 Participants	45.98 units on a scale STANDARD_DEVIATION 16.35 • n=177 Participants	44.98 units on a scale STANDARD_DEVIATION 14.61 • n=178 Participants	45.55 units on a scale STANDARD_DEVIATION 15.39 • n=510 Participants
Heart Failure Somatic Perception Scale	30.55 units on a scale STANDARD_DEVIATION 18.20 • n=155 Participants	30.18 units on a scale STANDARD_DEVIATION 18.25 • n=177 Participants	31.83 units on a scale STANDARD_DEVIATION 18.95 • n=178 Participants	30.87 units on a scale STANDARD_DEVIATION 18.46 • n=510 Participants
SF-12 (Physical Component Summary)	36.01 units on a scale STANDARD_DEVIATION 10.35 • n=155 Participants	35.01 units on a scale STANDARD_DEVIATION 9.16 • n=177 Participants	35.42 units on a scale STANDARD_DEVIATION 9.30 • n=178 Participants	35.46 units on a scale STANDARD_DEVIATION 9.57 • n=510 Participants

PRIMARY outcome

Timeframe: 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.