Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05269797 |
| Other study ID # |
Victoria Smye |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2022 |
| Est. completion date |
July 2022 |
Study information
| Verified date |
January 2022 |
| Source |
Western University, Canada |
| Contact |
Victoria Smye, PhD |
| Phone |
519-661-2111 |
| Email |
vsmye[@]uwo.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
There is an increase in Heart Failure (HF) hospitalizations and readmissions despite medical
advances (Desai & Stevenson, 2012; Ambrosy et al.,2014) and in spite of the education
provided to HF patients regarding the signs of fluid accumulation, HF exacerbations persist.
Unfortunately, there seems to be a gap between patients recognizing these signs of fluid
accumulation and performing timely self-management activities to control it. Currently, there
is no standardized approach for the delivery of a nurse-led health coaching intervention to
assist patients to engage in HF symptom management with self-care activities within a Primary
Health Care (PHC) setting. To address this gap, the aim of this research is to examine the
feasibility, acceptability, and initial effectiveness of a nurse-led health coaching
intervention, involving a self-care activity of the Adjusted Diuretic Dosing (ADD) tool with
stable HF patients and their significant others a PHC approach and within a PHC setting.
In the proposed study, nurses will engage with health coaching and a health coaching tool
(developed in Phase 1 of this research with the assistance of nurses working in this area) to
assist the patient to identify barriers to self-care and develop the patient's goals to
successfully engage in HF self-care strategies. It is also necessary for the nurse to capture
through documentation what decision-making strategies the nurse performed to assist the
patient with HF management. It is through these decision-making points, identified strategies
can be examined by the researcher to determine what care gaps or process has occurred. Also,
It is through the awareness of the patient's knowledge, skills, past experience, and values
and beliefs, those daily decisions will be made by the patient, e.g., decisions will be
influenced by the interactions among the person, the problem, and setting or environment -
they are situation-specific (Riegel et al., 2016). It is expected that through this kind of
naturalistic decision-making process the patient's self-confidence will increase to take
action towards maintaining HF self-care activities (such as medication and diet adherence,
and weight monitoring), respond to the perception of HF symptoms (seeking medical attention),
and be supported to manage their HF condition (adjusting diuretics in response to fluid
retention); this to support improved health outcomes and quality of life.
Description:
Purpose of the Study:
To determine the feasibility and acceptability of a nurse-led health coaching intervention to
support heart failure self-care management.
Hypothesis: A nurse-led health coaching intervention will engage patients to take action in
self-care activities that have the potential to increase self-care confidence and quality of
life for both the patient and their caregiver that will be measured by the Minnesota Living
with HF Questionnaire (MLHFQ) and Self-Care HF Index (SCHFI), and Caregiver Contribution for
Self-Care HF Index (CC-SCHFI).
It is an expectation the results of this study will inform nursing practice in this domain;
the results from this research study have the potential to improve the quality and
consistency of HF patient care with improved outcomes for persons living with HF.
Qualitative Research Questions:
1. What are those key elements of the nurse-led health coaching intervention that
facilitated or challenged the nurses' experiences to implement HF self-care management?
(nurse consultants in a focus group format)?
2. What are those elements of the nurse-led health coaching intervention that were helpful
and/or hindered patient experiences of self-management? (Feasibility: A focus group
interview with nurses and individual in-depth interviews with patient/caregiver dyads).
3. What is the impact of a nurse-led health coaching intervention? (A focus group interview
with nurses and individual in-depth interviews with patient/caregiver dyads).
This is a prospective, non-randomized, single dyad group cohort study utilizing purposive
sampling to enroll 6 -10 patients with HF and their caregivers (i.e., 6-10 dyads) over a
period of 6 months. The study design type will be conducted as a pre-post pilot feasibility
study since the primary objective is to evaluate the feasibility, acceptability, and
effectiveness of the health coaching intervention involving a self-care activity of the
Adjusted diuretic dosing (ADD) tool with stable HF for patients and their significant others
(through qualitative interviews with patients/spouses and nurses) in a family health care
setting. This study also will incorporate qualitative methods informed by interpretive
description to understand the experiences and decision-making strategies of the nurse
employing the intervention and the patient/caregiver dyad engaging in the intervention, i.e.,
in-depth nurse focus group and individual (dyad) interviews will be conducted. Identifying
what features facilitate nurse health coaching and/or challenge its implementation and those
features of nurse-led health coaching that were helpful and/or hindered the patient
experience of self-management will inform nursing practice in this realm. The secondary
objectives are related to evaluating 'trends' (due to an underpowered study) in specific
pre-post outcomes associated with the intervention. These identified trends involving
characteristics of Quality of Life (QoL) and self-care confidence will be measured by the
Minnesota Living with HF Questionnaire (MLHFQ) and Self-Care HF Index (SCHFI), and Caregiver
Contribution for Self-Care HF Index (CC-SCHFI) will provide a deeper understanding of the
qualitative data.
Patient population procedures:
Heart failure (HF) patients' standard of care can include frequent clinic visits from weekly
to every three months depending if HF medication therapy has been initiated or adjusted
(i.e., diuretics or ace-inhibitors). Also, it may include routine laboratory blood tests to
monitor electrolytes, renal function, and complete blood count. Other possible diagnostic
investigations that may be ordered as part of routine care according to evidence-based HF
guidelines include an echocardiogram, electrocardiogram, or chest x-ray.
In regard to the care management within a PHC setting, currently, nurses are not leading to
take a standardized approach towards health coaching and the practitioner prescribes a set
diuretic dosing (i.e., Lasix 40mg p.o. daily) with no opportunity to health coach on
self-adjust diuretic if HF symptoms worsen and weight gain has occurred. For this study, an
analysis of a nurse leading a health coaching approach by implementing the intervention to
identify challenges or barriers to HF self-care management and identifying strategies or
solutions with the patient and their caregiver will be conducted. Support from the care team
practitioners, either a Nurse Practitioner or family physician will be responsible and lead
medication adjustments by prescribing an adjusted diuretic dosing (ADD) which is the
self-care management tool within the health coaching intervention (i.e., baseline Lasix 40mg
daily, adjust Lasix 40 mg twice a day if weight gain of 3 lbs or more a day).
Nurse-led intervention:
A nurse-led health coaching HF self-care management intervention that is protocol-specific to
this study will be implemented. This involves a nurse leading a health coaching approach by
implementing the intervention with the patient to identify challenges or barriers to HF
self-care management and identifying strategies or solutions. This will be carried out at
baseline, 1 and 3-month clinic visits & during the phone visits @ 2 weeks and 8 weeks. If the
patient's symptoms deteriorate in between scheduled study visits, the patient will be
instructed at the start of the study that they need to contact the clinic to be seen by
either the Nurse Practitioner or physician as per current clinic practice and standard of
care. This clinic visit details will be documented in the electronic medical record (EMR) and
will be captured in the study as a non-schedule visit for the study by the study nurse
participant. The patient is also expected to weigh themselves every morning and record it,
along with any symptoms they may be experiencing on the "Cardiac congestion calendar" which
is part of the intervention that is provided to the patient.
The patient will complete a self-care confidence survey SCHFI (Self-care heart failure index)
and a quality-of-life questionnaire MLHFQ (Minnesota living heart failure questionnaire) at
the initial visit (baseline) and at the end of the study. The patient will be interviewed
separately via audio at the end of the study to explore their self-care management
experiences. This can be done either in the clinic or by phone.
