Topic: Primary Care Research Network for England, Cardiovascular
Conditions
Interventions
REACH HF Manual: The HF manual comprises a self-help manual which patients will work through with facilitation by the REACH-HF intervention facilitator. The manual includes information and interactive
Sponsors
Royal Cornwall Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (aged =18 years) 2. Patients who have a confirmed diagnosis of systolic HF on echocardiography (i.e. left ventricular ejection fraction <45%) within the last 5 years. 3. Patients who have been clinically stable for at least 2 weeks and in receipt of medical treatment for HF. 4. Patients deemed suitable for exercise, and who do not have a contraindication to exercise, as adjudged by the site Principal Investigator in collaboration with the local clinical team (with reference to the Amercian Heart Association 2013 guidelines). 5. Provision of informed consent to participate. Patient's caregivers aged 18 years or older may participate if the meet the following definition: ?Someone who provides unpaid support to a family member or friend with heart failure who is enrolled in the study'. Intervention nurses will only participate following completion of the HF Manual training course and the provision of informed consent to provide study data.
Exclusion criteria
Exclusion criteria: 1. Patients who have undertaken cardiac rehabilitation (CR) within the last 12 months 2. Patients who have received an ICD or CRT or combined CRT/ICD device implanted in the last 6 months. 3. Patients who are in a long-term care establishment or who are unwilling or unable to travel to research assessments or accommodate home visits. 4. Patients who are unable to read English. 5. Patients judged to be unable to participate in the study for any other reason e.g. psychiatric disorder, diagnosis of dementia, life threatening co-morbidity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility and acceptability of intervention delivery and proposed outcomes battery. Methods for data collection will include qualitative methods e.g. interviews with patients, carers and intervention faciltators, recording of intervention nurse and patient interactions and qualitative outcomes e.g. recruitment and attrition rate, patient and carer satisfaction questionnaires. These outcomes will be assessed over the 3 months of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following health-related outcomes will be collected at clinic visits at baseline (prior to intervention) at 3 months following baseline: 1. Disease-specific health-related quality of life (HRQoL) measured using the MLHFQW [patients] 2. Composite outcome of death or hospital admission related to HF or not related to HF [patients] 3. Blood natriuretic peptide levels [patients] 4. Exercise capacity (incremental shuttle walking test) [patients] 5. Psychological wellbeing (Hospital Anxiety and Depression Scale, HADS) [patients & caregivers] 6. Physical activity level (accelerometry over a 7-day period) [patients] 7. Eneric health-related quality of life (EQ-5D) [patients] 8. Disease-specific quality of life (HeartQoL) [patients] 9. Self-care of Heart Failure Index (SCHFI) [caregivers] 10. Caregiver Burden Questionnaire ? Heart Failure (CBQ-HF) [caregivers] 11. Caregiver Contribution to Self-care of Heart Failure Index (CC-SCHFI) [caregivers] 12. Family Caregiver-Specific Quality of Life Scale (FAMQOL) [caregivers] 13. Healthcare utilisation (primary and secondary care contacts, social care contacts and medication usage) [patients] 14. Safety outcomes (worsening HF event, musculoskeletal injuries, dropout due to adverse events) [patients] | — |
Countries
United Kingdom
Outcome results
None listed