PROspective MEmory Training to improve HEart failUre Self-care (PROMETHEUS): study protocol for a randomised controlled trial

Abstract

Background: Cognitive impairment is seen in up to three quarters of heart failure (HF) patients and has a significant negative impact on patients' health outcomes. Prospective memory, which is defined as memory to carry out future intentions, is important for functional independence in older adults and involves application of multiple cognitive processes that are often impaired in HF patients. The objective of this study is to examine the effects of prospective memory training on patients' engagement in HF self-care and health outcomes, carer strain and quality of life.

Methods/design: The proposed study is a randomised, controlled trial in which 200 patients diagnosed with HF, and their carers will be recruited from 3 major hospitals across Melbourne. Eligible patients with HF will be randomised to receive either: 1) The Virtual Week Training Program - a computerised prospective memory (PM) training program (intervention) or 2) non-adaptive computer-based word puzzles (active control). HF patients' baseline cognitive function will be compared to a healthy control group (n = 60) living independently in the community. Patients will undergo a comprehensive assessment of PM, neuropsychological functioning, self-care, physical, and emotional functioning. Assessments will take place at baseline, 4 weeks and 12 months following intervention. Carers will complete measures assessing quality of life, strain, perceived control in the management of the patients' HF symptoms, and ratings of the patients' level of engagement in HF self-care behaviours.

Discussion: If the Virtual Week Training Program is effective in improving: 1) prospective memory; 2) self-care behaviours, and 3) wellbeing in HF patients, this study will enhance our understanding of impaired cognitive processes in HF and potentially is a mechanism to reduce healthcare costs.

Trial registration: Australian New Zealand Clinical Trials Registry #366376; 27 May 2014. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366376&isClinicalTrial=False .

Figure 1

Consolidated Standards of Reporting Trials (CONSORT) diagram illustrating study procedures. Key: BNP, brain natriuretic peptide; CAS-R, Control Attitudes Scale - Revised; CC-SCHFI, Caregiver Contribution Self-Care Heart Failure Index; CRA, Caregiver Reaction Assessment; Dyadic HF Typology, Dyadic Heart Failure Typology; HADS, Hospital Anxiety and Depression Scale; Heart-FaST, Heart Failure Self-care Screening Tool; HF, heart failure; MIST, Memory for Intentions Screening Test; MCSI, Modified Caregiver Strain Index; MoCA, Montreal Cognitive Assessment; NP-battery test, Neuropsychological battery test; Proxy IADL, Proxy measure Instrumental Activities of Daily Living; SCHFI, Self-Care Heart Failure Index; TIADL, Timed Activities of Daily Living.