Statistical analysis plan for the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke randomised controlled clinical trial.

BACKGROUND: Unplanned hospital presentations may occur post-stroke due to inadequate preparation for transitioning from hospital to home. The Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) trial was designed to test the effectiveness of receiving a 12-week, self-management intervention, comprising personalised goal setting with a clinician and aligned educational/motivational electronic messages. Primary outcome is as follows: self-reported unplanned hospital presentations (emergency department/admission) within 90-day post-randomisation. We present the statistical analysis plan for this trial. METHODS/DESIGN: Participants are randomised 1:1 in variable block sizes, with stratification balancing by age and level of baseline disability. The sample size was 890 participants, calculated to detect a 10% absolute reduction in the proportion of participants reporting unplanned hospital presentations/admissions, with 80% power and 5% significance level (two sided). Recruitment will end in December 2023 when funding is expended, and the sample size achieved will be used. Logistic regression, adjusted for the stratification variables, will be used to determine the effectiveness of the intervention on the primary outcome. Secondary outcomes will be evaluated using appropriate regression models. The primary outcome analysis will be based on intention to treat. A p-value ≤ 0.05 will indicate statistical significance. An independent Data Safety and Monitoring Committee has routinely reviewed the progress and safety of the trial. CONCLUSIONS: This statistical analysis plan ensures transparency in reporting the trial outcomes. ReCAPS trial will provide novel evidence on the effectiveness of a digital health support package post-stroke. TRIAL REGISTRATION: ClinicalTrials.gov ACTRN12618001468213. Registered on August 31, 2018. SAP version 1.13 (October 12 2023) Protocol version 1.12 (October 12, 2022) SAP revisions Nil.

A mixed-methods feasibility study of a new digital health support package for people after stroke: the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) intervention.

BACKGROUND: Evidence for digital health programmes to support people living with stroke is growing. We assessed the feasibility of a protocol and procedures for the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) trial. METHODS: We conducted a mixed-method feasibility study. Participants with acute stroke were recruited from three hospitals (Melbourne, Australia). Eligibility: Adults with stroke discharged from hospital to home within 10 days, modified Rankin Score 0-4 and prior use of Short Message System (SMS)/email. While in hospital, recruited participants contributed to structured person-centred goal setting and completed baseline surveys including self-management skills and health-related quality of life. Participants were randomised 7-14 days after discharge via REDCap® (1:1 allocation). Following randomisation, the intervention group received a 12-week programme of personalised electronic support messages (average 66 messages sent by SMS or email) aligned with their goals. The control group received six electronic administrative messages. Feasibility outcomes included the following: number of patients screened and recruited, study retainment, completion of outcome measures and acceptability of the ReCAPS intervention and trial procedures (e.g. participant satisfaction survey, clinician interviews). Protocol fidelity outcomes included number of goals developed (and quality), electronic messages delivered, stop messages received and engagement with messages. We undertook inductive thematic analysis of interview/open-text survey data and descriptive analysis of closed survey questions. RESULTS: Between November 2018 and October 2019, 312 patients were screened; 37/105 (35%) eligible patients provided consent (mean age 61 years; 32% female); 33 were randomised (17 to intervention). Overall, 29 (88%) participants completed the12-week outcome assessments with 12 (41%) completed assessments in the allocated timeframe and 16 also completing the satisfaction survey (intervention=10). Overall, trial participants felt that the study was worthwhile and most would recommend it to others. Six clinicians participated in one of three focus group interviews; while they reported that the trial and the process of goal setting were acceptable, they raised concerns regarding the additional time required to personalise goals. CONCLUSION: The study protocol and procedures were feasible with acceptable retention of participants. Consent and goal personalisation procedures should be centralised for the phase III trial to reduce the burden on hospital clinicians. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12618001468213 (date 31/08/2018); Universal Trial Number: U1111-1206-7237.

Sensitivity and Specificity of a Five-Minute Cognitive Screening Test in Patients With Heart Failure.

BACKGROUND: Cognitive impairment occurs in up to 80% of patients with heart failure (HF). The National Institute for Neurological Disorders and Stroke (NINDS) and the Canadian Stroke Network (CSN) recommend a 5-minute cognitive screening protocol that has yet to be psychometrically evaluated in HF populations. The aim of this study was to conduct a secondary analysis of the sensitivity and specificity of the NINDS-CSN brief cognitive screening protocol in HF patients. METHODS: The Montreal Cognitive Assessment (MoCA) was administered to 221 HF patients. The NINDS-CSN screen comprises 3 MoCA items, with lower scores indicating poorer cognitive function. Receiver operator characteristic (ROC) curves were constructed, determining the sensitivity, specificity and appropriate cutoff scores of the NINDS-CSN screen. RESULTS: In an HF population aged 76 ± 12 years, 136 (62%) were characterized with cognitive impairment (MoCA <26). Scores on the NINDS-CSN screen ranged from 3-11. The area under the receiver operating characteristic curve indicated good accuracy in screening for cognitive impairment (0.88; P < .01; 95% CI 0.83-0.92). A cutoff score of ≤9 provided 89% sensitivity and 71% specificity. CONCLUSIONS: The NINDS-CSN protocol offers clinicians a feasible telephone method to screen for cognitive impairment in patients with HF. Future studies should include a neuropsychologic battery to more comprehensively examine the diagnostic accuracy of brief cognitive screening protocols.

Symptom recognition in elders with heart failure.

PURPOSE: Aging is associated with losses in hearing and vision. The objective of this study was to assess whether aging also is associated with less ability to detect and interpret afferent physiological information. DESIGN: A cross-sectional mixed methods study was conducted with 29 persons with a confirmed diagnosis of chronic heart failure of at least 6 months duration. The sample was divided at the median to compare younger (<73 years) versus older (> or = 73 years) patients in the ability to detect and interpret their heart failure symptoms. METHODS: Shortness of breath was stimulated using a 6-minute walk test (6MWT) and used to assess the ability of heart failure patients to detect shortness of breath using the Borg measure of perceived exertion compared with gold standard ratings of each person's shortness of breath by trained registered nurse research assistants (inter-rater congruence 0.91). Accuracy of ratings by older patients was compared with those of younger patients. In-depth interviews were used to assess symptom interpretation ability. FINDINGS: Integrated quantitative and qualitative data confirmed that older patients had more difficulty in detecting and interpreting shortness of breath than younger patients. Older patients were twice as likely as younger to report a different level of shortness of breath than that noted by the registered nurse research assistants immediately after the 6MWT. CONCLUSIONS: These results support our theory of an age-related decline in the ability to attend to internal physical symptoms. This decline may be a cause of poor early symptom detection. CLINICAL RELEVANCE: The results of this study suggest that there is a need to develop interventions that focus on the symptom experience to help patients-particularly older ones-in somatic awareness and symptom interpretation. It may be useful to explore patients' statements about how they feel: "Compared to what? How do you feel today compared to yesterday?"

Testing a model of patient characteristics, psychologic status, and cognitive function as predictors of self-care in persons with chronic heart failure.

OBJECTIVE: Self-care is a key component in the management of chronic heart failure (CHF). Yet there are many barriers that interfere with a patient's ability to undertake self-care. The primary aim of the study was to test a conceptual model of determinants of CHF self-care. Specifically, we hypothesized that cognitive function and depressive symptoms would predict CHF self-care. METHODS: Fifty consecutive patients hospitalized with CHF were assessed for self-care (Self-Care of Heart Failure Index), cognitive function (Mini Mental State Exam), and depressive symptoms (Cardiac Depression Scale) during their index hospital admission. Other factors thought to influence self-care were tested in the model: age, gender, social isolation, self-care confidence, and comorbid illnesses. Multiple regression was used to test the model and to identify significant individual determinants of self-care maintenance and management. RESULTS: The model of 7 variables explained 39% (F [7, 42] 3.80; P = .003) of the variance in self-care maintenance and 38% (F [7, 42] 3.73; P = .003) of the variance in self-care management. Only 2 variables contributed significantly to the variance in self-care maintenance: age (P < .01) and moderate-to-severe comorbidity (P < .05). Four variables contributed significantly to the variance in self-care management: gender (P < .05), moderate-to-severe comorbidity (P < .05), depression (P < .05), and self-care confidence (P < .01). When cognitive function was removed from the models, the model explained less of the variance in self-care maintenance (35%) (F [6, 43] 3.91; P = .003) and management (34%) (F [6, 43] 3.71; P = .005). CONCLUSION: Although cognitive function added to the model in predicting both self-care maintenance and management, it was not a significant predictor of CHF self-care compared with other modifiable and nonmodifiable factors. Depression explained only self-care management.

Prognostic importance of cognitive impairment in chronic heart failure patients: does specialist management make a difference?

BACKGROUND: Cognitive impairment is common among chronic heart failure (CHF) patients. AIMS: To determine the prognostic significance of cognitive impairment in patients participating in a randomized study of a CHF management program (CHF-MP). METHODS: CHF patients were randomized to a CHF-MP (n=100) or usual care (n=100). Baseline cognition was assessed using the Mini Mental Status Examination (MMSE). Five-year all-cause mortality, and combined death-or-readmission, were compared on the basis of the presence (MMSE 19-26) or absence (MMSE >26) of cognitive impairment. RESULTS: 27 patients (13.5%) had cognitive impairment and, on an adjusted basis, were more likely to die (96.3% versus 68.2%. RR 2.19, 95% CI 1.41 to 3.39: P<0.001) and/or experience an unplanned hospitalization (100% versus 94%. RR 1.44, 95% CI 1.06 to 1.95: P=0.019). Cognitively impaired patients had a similar (non-significant) adjusted risk of death-or-readmission in both the CHF-MP (RR 1.40, 95% CI 0.63 to 3.11: P=0.403) and in usual care (RR 1.38, 95% CI 0.75 to 2.53: P=0.305). In the usual care cohort, cognitive impairment was associated with a greater (non-significant), adjusted risk of death (RR 1.61, 95% CI 1.10 to 4.92: P=0.122). In the CHF-MP, adjusted risk of death was significantly higher for cognitively impaired patients (RR 2.33, 95% CI 1.10 to 4.92: P=0.027). CONCLUSION: These data suggest that "mild" cognitive impairment is of prognostic importance in CHF: even when a CHF-MP has been applied.