NCT05269797

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable heart-failure

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

March 25, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

January 26, 2022

Last Update Submit

March 9, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Quality of Life Scale on the Minnesota Living with Heart Failure Questionnaire (MLHFQ)

    The Minnesota Living with Heart Failure Questionnaire (MLHFQ) is a 21-item paper self- administered questionnaire designed as a measure of heart failure, as indicated by its adverse effects on patients' lives. The MLHFQ quantifies a single overall score as a measure of the impact of heart failure on the patient's life. Higher scores indicate worse physical and emotional quality of life. Physical 0-40 Emotional 0-25

    Baseline

  • Patient Self Confidence on the Self-Care Heart Failure Index (SCHFI)

    Patient Self-Confidence on the Self-Care Heart Failure Index (SCHFI) measures self-care with three scales: self-care maintenance, measuring behaviors to maintain HF stability; symptom perception, measuring monitoring behaviors; and self-care management, assessing the response to symptoms.Physical 0-40 Emotional 0-25 Scores 0-100.

    Baseline

  • Caregiver Self Confidence on the Caregiver Contribution for Self-Care Heart Failure Index (CC-SCHFI)

    The Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) measures these contributions across three scales: self-care maintenance (symptom monitoring and treatment adherence); self-care management (dealing with symptoms); and confidence in contributing to the self-care (self-efficacy in managing self-care). Higher scores indicating greater caregiver contributions to heart failure self-care. Scores 0-100.

    Baseline

Secondary Outcomes (3)

  • Changes in the Quality of Life Scale on the Minnesota Living with Heart Failure Questionnaire (MLHFQ)

    6 months

  • Changes in Patient Self Confidence on the Self-Care Heart Failure Index (SCHFI)

    6 months

  • Changes in Caregiver Self Confidence on the Caregiver Contribution for Self-Care Heart Failure Index (CC-SCHFI)

    6 months

Study Arms (1)

Health-coaching Intervention

EXPERIMENTAL

A nurse-lead health coaching intervention to support heart failure self-care management is employed by the nurses. This is a pre-post single group design - there is only one arm.

Behavioral: Nurse-led health coaching re: heart failure self-care management

Interventions

A focus group meeting will be arranged with the nurse participants to provide training on the study intervention specific to the Nurse-led health coaching intervention. The intervention involves identifying barriers and finding strategies and solutions to self-care management, while employing a self-care HF management tool of adjusting diuretic dosing (ADD) according to the congestive cardiac calendar (designed in collaboration with nurses in Phase 1). It will be essential for the nurses to document key information pertaining to the rationale for these decision-making strategies or solutions. This is in comparison to the standard of care in primary health care of nurses not taking a standardize approach towards health coaching and the patient being instructed by the practitioner to take a set diuretic dosing (SDD).

Health-coaching Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult HF patients (age 18 years or older) with a documented diagnosis of HF on the medical record who are stable with no acute signs of HF decompensation and on a stable dose of diuretics for a minimum of three months.
  • Patients registered within the Family Medical Clinics in London who have a caregiver or support defined by a person who provides either direct HF support (medication or meal preparation) or indirect HF support (providing emotional support, transportation, or assisting with decision-making around symptom perception or management).
  • Patient and caregiver dyads who have a willingness and ability to participate in an interview and complete surveys; and
  • English speaking.
  • Registered nurses, including Nurse Practitioners employed at the Family Medical Clinics in London who participate in the care of patients living with HF.

You may not qualify if:

  • A person with cognitive impairment that would interfere with their ability to provide informed consent.
  • A person with any medical condition that has an expected survival of less than 6 months: End-stage renal disease, end-stage liver disease, end stage Chronic Obstructive Pulmonary Disease (COPD), end-stage/terminal cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Victoria Smye, PhD

    Western University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Smye, PhD

CONTACT

Maureen Leyser, MN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Behavioural
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2022

First Posted

March 8, 2022

Study Start

April 1, 2022

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

March 25, 2022

Record last verified: 2022-01