MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients

MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients (MOTIVATE-HF): Study Protocol of a Three-arm Multicenter Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02894502

Acronym

MOTIVATE-HF

Enrollment

510

Registered

2016-09-09

Start date

2014-06-30

Completion date

2018-10-31

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Self-care, Motivational interviewing, Heart failure, Caregivers

Brief 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. 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.

Interventions

BEHAVIORALMotivational 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Self-care Maintenance in Patients	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.

Secondary

Measure	Time frame	Description
Patient and Caregiver Generic Physical and Mental Quality of Life	3, 6, 9 and 12 months from the intervention	Patient and caregiver generic physical and mental quality of life will be assessed with the Short Form 12 (SF-12).
Patient and Caregiver Anxiety and Depression	3, 6, 9 and 12 months from the intervention	Patient and caregiver anxiety and depression will be evaluated with the Hospital Anxiety and Depression Scale
Patient HF Specific Quality of Life	3, 6, 9 and 12 months from the intervention	Patient HF specific quality of life will be evaluated with the Kansas City Cardiomyopathy Questionnaire
Patient and Caregiver Quality of Nocturnal Sleep	3, 6, 9 and 12 months from the intervention	We will use the Pittsburgh Sleep Quality Index
Patient and Caregiver Mutuality	3, 6, 9 and 12 months from the intervention	We will use the Mutuality Scale
Burden of HF Symptoms in Patients	3, 6, 9 and 12 months from the intervention	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.
Caregiver Perceived Social Support	3, 6, 9 and 12 months from the intervention	We will use the Multidimensional Scale of Perceived Social Support Scale
Patient Hospitalizations	3, 6, 9 and 12 months from the intervention	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.
Use of Emergency Services	3, 6, 9 and 12 months from the intervention	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.
Death	3, 6, 9 and 12 months from the intervention	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.
Caregiver Preparedness	3, 6, 9 and 12 months from the intervention	Caregiver Preparedness will be evaluated with the Caregiver Preparedness Scale

Countries

Italy

Participant flow

Participants by arm

Arm	Count
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.	155
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.	177
Control Group This Group will receive the usual care	178
Total	510

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Baseline	Death	3	1	9
Baseline	Withdrawal by Subject	24	31	36
First Follow up	Death	2	2	3
First Follow up	Withdrawal by Subject	32	29	37
Second Follow up	Death	2	3	1
Second Follow up	Withdrawal by Subject	13	15	13
Third Follow up	Death	1	1	0
Third Follow up	Withdrawal by Subject	5	6	3

Baseline characteristics

Characteristic	Total	Control Group	Motivational Interviewing Only for Patients	Motivational Interviewing to Patients and Caregivers
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	381 Participants	130 Participants	119 Participants	132 Participants
Age, Categorical Between 18 and 65 years	127 Participants	47 Participants	35 Participants	45 Participants
Age, Continuous	72.37 Years STANDARD_DEVIATION 12.28	72.45 Years STANDARD_DEVIATION 13.66	72.19 Years STANDARD_DEVIATION 12.29	72.45 Years STANDARD_DEVIATION 10.79
Heart Failure Somatic Perception Scale	30.87 units on a scale STANDARD_DEVIATION 18.46	31.83 units on a scale STANDARD_DEVIATION 18.95	30.55 units on a scale STANDARD_DEVIATION 18.2	30.18 units on a scale STANDARD_DEVIATION 18.25
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	510 Participants	178 Participants	155 Participants	177 Participants
Self-Care of Heart Failure Index	45.55 units on a scale STANDARD_DEVIATION 15.39	44.98 units on a scale STANDARD_DEVIATION 14.61	45.72 units on a scale STANDARD_DEVIATION 15.23	45.98 units on a scale STANDARD_DEVIATION 16.35
Sex: Female, Male Female	214 Participants	69 Participants	75 Participants	70 Participants
Sex: Female, Male Male	296 Participants	109 Participants	80 Participants	107 Participants
SF-12 (Physical Component Summary)	35.46 units on a scale STANDARD_DEVIATION 9.57	35.42 units on a scale STANDARD_DEVIATION 9.3	36.01 units on a scale STANDARD_DEVIATION 10.35	35.01 units on a scale STANDARD_DEVIATION 9.16

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	8 / 155	7 / 177	13 / 178
other Total, other adverse events	0 / 0	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0	0 / 0

Outcome results

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.

Time frame: 3 months from the intervention

Arm	Measure	Value (MEAN)	Dispersion
Motivational Interviewing Only for Patients	Self-care Maintenance in Patients	52.36 score on a scale	Standard Deviation 22.67
Motivational Interviewing to Patients and Caregivers	Self-care Maintenance in Patients	54.23 score on a scale	Standard Deviation 20.36
Control Group	Self-care Maintenance in Patients	49.63 score on a scale	Standard Deviation 17.49

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.