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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

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

Authors: Jan Cameron, Peter G Rendell, Chantal F Ski, Christina E Kure, Skye N McLennan, Nathan S Rose, David L Prior, David R Thompson

Published in: Trials | Issue 1/2015

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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.
Literature
1.
Moser DK, Lee KS, Wu JR, Mudd-Martin G, Jaarsma T, Huang TY, et al. Identification of symptom clusters among patients with heart failure: an international observational study. Int J Nurs Stud. 2014;51:1366–72.CrossRefPubMedPubMedCentral
2.
Bui AL, Horwich TB, Fonarow GC. Epidemiology and risk profile of heart failure. Nat Rev Cardiol. 2011;8:30–41.CrossRefPubMed
3.
Cameron J, Worrall-Carter L, Page K, Stewart S, Ski CF. Screening for mild cognitive impairment in patients with heart failure: Montreal Cognitive Assessment versus Mini Mental State Exam. Eur J Cardiovasc Nurs. 2013;12:252–60.CrossRefPubMed
4.
McLennan S, Pearson S, Cameron J, Stewart S. Prognostic importance of cognitive impairment in chronic heart failure patients: does specialist management make a difference? Eur J Heart Fail. 2006;8:494–501.CrossRefPubMed
5.
Cameron J, Worrall-Carter L, Page K, Riegel B, Lo SK, Stewart S. Does cognitive impairment predict poor self-care in patients with chronic heart failure? Eur J Heart Fail. 2010;12:508–15.CrossRefPubMed
6.
Vogels RLC, Scheltens P, Schroeder-Tanka JM, Weinstein HC. Cognitive impairment in heart failure: a systematic review of the literature. Eur J Heart Fail. 2007;9:440–9.CrossRefPubMed
7.
Lee CS, Moser DK, Lennie TA, Riegel B. Event-free survival in adults with heart failure who engage in self-care management. Heart Lung. 2011;40:12–20.CrossRefPubMed
8.
Pressler SJ, Kim J, Riley P, Ronis D, Gradus-Pizlo I. Memory dysfunction, psychomotor slowing, and decreased executive function predict mortality in patients with heart failure and low ejection fraction. J Card Fail. 2010;16:750–60.CrossRefPubMedPubMedCentral
9.
Riegel B, Lee CS, Dickson VV. Self care in patients with chronic heart failure. Nat Rev Cardiol. 2011;8:644–54.CrossRefPubMed
10.
Cameron J, Worrall-Carter L, Riegel B, Lo SK, Stewart S. Testing a model of patient characteristics, psychological status and cognitive function as predictors of self-care in persons with heart failure. Heart Lung. 2009;38:410–8.CrossRefPubMed
11.
Oosterom-Calo R, Van Ballegooijen AJ, Terwee CB, Te Velde SJ, Brouwer IA, Jaarsma T, et al. Determinants of adherence to heart failure medication: a systematic literature review. Heart Fail Rev. 2013;18:409–27.CrossRefPubMed
12.
Cameron J, Ski CF, Thompson DR. Screening for determinants of self-care in patients with chronic heart failure. Heart Lung Circ. 2012;21:806–8.CrossRefPubMed
13.
Currie K, Rideout A, Lindsay G, Harkness K. The association between mild cognitive impairment and self-care in adults with chronic heart failure: a systematic review and narrative synthesis. J Cardiovasc Nurs. Published ahead of print 06/07/2014. doi: 10.1097/jcn.0000000000000173
14.
Einstein GO, McDaniel MA. Normal aging and prospective memory. J Exp Psychol Learn Mem Cogn. 1990;16:717–26.CrossRefPubMed
15.
Henry JD, MacLeod MS, Phillips LH, Crawford JR. A meta-analytic review of prospective memory and aging. Psychol Aging. 2004;19:27–39.CrossRefPubMed
16.
Rendell PG, Henry JD. A review of virtual week for prospective memory assessment: clinical implications. Brain Impair. 2009;10:14–22.CrossRef
17.
Einstein GO, McDaniel MA. Prospective memory: multiple retrieval processes. Curr Dir Psychol Sci. 2005;14:286–90.CrossRef
18.
Shum D, Fleming J. Understanding, assessing and treating prospective memory: some recent advances. Brain Impair. 2009;10:1–2.CrossRef
19.
Koçer A, Esen Ö, Ince N, Gözke E, Karakaya O, Barutçu I. Heart failure with low cardiac output and risk of development of lesions in the cerebral white matter. Eur J Gen Med. 2005;2:56–61.
20.
21.
Knecht KM, Alosco ML, Spitznagel MB, Cohen R, Raz N, Sweet L, et al. Sleep apnea and cognitive function in heart failure. Cardiovasc Psychiatry Neurol. 2012;2012:402079.CrossRefPubMedPubMedCentral
22.
Miller LA, Spitznagel MB, Alosco ML, Cohen RA, Raz N, Sweet LH, et al. Cognitive profiles in heart failure: a cluster analytic approach. J Clin Exp Neuropsychol. 2012;34:509–20.CrossRefPubMedPubMedCentral
23.
Picano E, Bruno RM, Ferrari GF, Bonuccelli U. Cognitive impairment and cardiovascular disease: so near, so far. Int J Cardiol. 2014;175:21–9.CrossRefPubMed
24.
Woo MA, Kumar R, Macey PM, Fonarow GC, Harper RM. Brain injury in autonomic, emotional, and cognitive regulatory areas in patients with heart failure. J Card Fail. 2009;15:214–23.CrossRefPubMed
25.
Alosco ML, Brickman AM, Spitznagel MB, Griffith EY, Narkhede A, Cohen R, et al. Reduced cerebral blood flow and white matter hyperintensities predict poor sleep in heart failure. Behav Brain Funct. 2013;9:42.CrossRefPubMedPubMedCentral
26.
Almeida OP, Garrido GJ, Beer C, Lautenschlager NT, Arnolda L, Flicker L. Cognitive and brain changes associated with ischaemic heart disease and heart failure. Eur Heart J. 2012;33:1769–76.CrossRefPubMed
27.
Vogels RL, Oosterman JM, van Harten B, Gouw AA, Schroeder-Tanka JM, Scheltens P, et al. Neuroimaging and correlates of cognitive function among patients with heart failure. Dementia Ger Cogn. 2007;24:418–23.CrossRef
28.
Rose NS, Rendell PG, McDaniel MA, Aberle I, Kliegel M. Age and individual differences in prospective memory during a ‘Virtual Week’: the roles of working memory, vigilance, task regularity, and cue focality. Psychol Aging. 2010;25:595–605.CrossRefPubMedPubMedCentral
29.
Thompson C, Henry JD, Rendell PG, Withall A, Brodaty H. Prospective memory function in mild cognitive impairment and early dementia. J Int Neuropsychol Soc. 2010;16:318–25.CrossRefPubMed
30.
Rendell PG, Craik FIM. Virtual week and actual week: Age-related differences in prospective memory. Appl Cogn Psychol. 2000;14:S43–62.CrossRef
31.
Habota T, Cameron J, McLennan SN, Ski CF, Thompson DR, Rendell PG. Prospective memory in chronic heart failure (O160). Global Heart. 2014;9, e44.CrossRef
32.
McDaniel MA, Bugg JM. Memory training interventions: what has been forgotten? J Appl Res Mem Cogn. 2012;1:45–50.CrossRef
33.
Hering A, Rendell PG, Rose NS, Schnitzspahn KM, Kliegel M. Prospective memory training in older adults and its relevance for successful aging. Psychol Res. 2014;78:892–904.CrossRefPubMed
34.
Krum H, Jelinek MV, Stewart S, Sindone A, Atherton JJ. Update to National Heart Foundation of Australia and Cardiac Society of Australia and New Zealand Guidelines for the prevention, detection and management of chronic heart failure in Australia, 2006. Med J Aust. 2011;2011(194):405–9.
35.
Mioshi E, Dawson K, Mitchell J, Arnold R, Hodges JR. The Addenbrooke’s Cognitive Examination Revised (ACE-R): a brief cognitive test battery for dementia screening. Int J Geriatr Psych. 2006;21:1078–85.CrossRef
36.
Cameron J, Ski CF, McLennan SN, Rendell PG, Whitbourn RJ, Thompson DR. Development of the Heart Failure Screening Tool (Heart-FaST) to measure barriers that impede engagement in self-care. Eur J Cardiovasc Nurs. 2014;13:408–17.CrossRefPubMed
37.
Cameron J, Habota T, Ski CF, McLennan SN, Rendell PG, Thompson DR. Preliminary evaluation of the Heart Failure Screening Tool (Heart-FaST): assessing for patient barriers to engagement in heart failure self-care. J Card Fail. 2014;20:S11–2.CrossRef
38.
39.
Jaarsma T, Arestedt KF, Martensson J, Dracup K, Stromberg A. The European Heart Failure Self-care Behaviour scale revised into a nine-item scale (EHFScB-9): a reliable and valid international instrument. Eur J Heart Fail. 2009;11:99–105.CrossRefPubMed
40.
Lee CS, Lyons KS, Gelow JM, Mudd JO, Hiatt SO, Nguyen T, et al. Validity and reliability of the European Heart Failure Self-care Behavior Scale among adults from the United States with symptomatic heart failure. Eur J Cardiovasc Nurs. 2013;12:214–8.CrossRefPubMed
41.
Moser DK, Riegel B, McKinley S, Doering LV, Meischke H, Heo S, et al. The control attitudes scale-revised: psychometric evaluation in three groups of patients with cardiac illness. Nurs Res. 2009;58:42–51.CrossRefPubMedPubMedCentral
42.
Chung ML, Pressler SJ, Dunbar SB, Lennie TA, Moser DK. Predictors of depressive symptoms in caregivers of patients with heart failure. J Cardiovasc Nurs. 2010;25:411–9.CrossRefPubMedPubMedCentral
43.
Hwang B, Fleischmann KE, Howie-Esquivel J, Stotts NA, Dracup K. Caregiving for patients with heart failure: impact on patients’ families. Am J Crit Care. 2011;20:431–42.CrossRefPubMed
44.
Ware J, Kosinski M, Keller S. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34:220–33.CrossRefPubMed
45.
Mesquita R, Janssen DJA, Wouters EFM, Schols JMGA, Pitta F, Spruit MA. Within-day test-retest reliability of the Timed Up & Go test in patients with advanced chronic organ failure. Arch Phys Med Rehab. 2013;94:2131–8.CrossRef
46.
47.
Buck HG, Zambroski CH, Hupcey JE. Assessing the response of patients and spousal/partner caregivers to a new instrument measuring dyadic heart failure care types. Eur J Cardiovasc Nurs. 2013;12:209–13.CrossRefPubMedPubMedCentral
48.
Zigmond A, Snaith R. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–70.CrossRefPubMed
49.
Bjelland I, Dahl A, Haug T, Neckelmann D. The validity of the hospital anxiety and depression scale. An updated literature review. J Psychosom Res. 2002;52:69–77.CrossRefPubMed
50.
Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, et al. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005;53:695–9.CrossRefPubMed
51.
Pendlebury ST, Mariz J, Bull L, Mehta Z, Rothwell PM. MoCA, ACE-R, and MMSE versus the national institute of neurological disorders and stroke-canadian stroke network vascular cognitive impairment harmonization standards neuropsychological battery after TIA and stroke. Stroke. 2012;43:464–9.CrossRefPubMed
52.
Raskin SA. Memory for intentions screening test: psychometric properties and clinical evidence. Brain Impair. 2009;10:23–33.CrossRef
53.
Karantzoulis S, Troyer AK, Rich JB. Prospective memory in amnestic mild cognitive impairment. J Int Neuropsychol Soc. 2009;15:407–15.CrossRefPubMed
54.
Woods SP, Moran LM, Dawson MS, Carey CL, Grant I, Atkinson JH, et al. Psychometric characteristics of the memory for intentions screening test. Clin Neuropsychol. 2008;22:864–78.CrossRefPubMedPubMedCentral
55.
56.
Owsley C, Sloane M, McGwin Jr G, Ball K. Timed instrumental activities of daily living tasks: relationship to cognitive function and everyday performance assessments in older adults. Gerontology. 2002;48:254–65.CrossRefPubMed
57.
de Jager CA, Schrijnemaekers ACMC, Honey TEM, Budge MM. Detection of MCI in the clinic: evaluation of the sensitivity and specificity of a computerised test battery, the Hopkins Verbal Learning Test and the MMSE. Age and Ageing. 2009;38:455–60.CrossRefPubMed
58.
Maruff P, Thomas E, Cysique L, Brew B, Collie A, Snyder P, et al. Validity of the CogState brief battery: relationship to standardized tests and sensitivity to cognitive impairment in mild traumatic brain injury, schizophrenia, and AIDS dementia complex. Arch Clin Neuropsych. 2009;24:165–78.CrossRef
59.
Crowe SF. The differential contribution of mental tracking, cognitive flexibility, visual search, and motor speed to performance on parts A and B of the Trail Making Test. J Clin Psychol. 1998;54:585–91.CrossRefPubMed
60.
Benedict RHB, Schretlen D, Groninger L, Brandt J. Hopkins verbal learning test - Revised: normative data and analysis of inter-form and test-retest reliability. Clinical Neuropsychol. 1998;12:43–55.CrossRef
61.
Brandt J. The Hopkins Verbal Learning Test: development of a new memory test with six equivalent forms. Clinical Neuropsychol. 1991;5:125–42.CrossRef
62.
Hogervorst E, Combrinck M, Lapuerta P, Rue J, Swales K, Budge M. The Hopkins Verbal Learning Test and screening for dementia. Demen Geriatr Cogn. 2002;13:13–20.CrossRef
63.
Nelson HE, O’Connell A. Dementia: the estimation of premorbid intelligence levels using the New Adult Reading Test. Cortex. 1978;14:234–44.CrossRefPubMed
64.
Crawford JR, Deary IJ, Starr J, Whalley LJ. The NART as an index of prior intellectual functioning: a retrospective validity study covering a 66-year interval. Psychol Med. 2001;31:451–8.CrossRefPubMed
65.
Vellone E, Riegel B, Cocchieri A, Barbaranelli C, D’Agostino F, Glaser D, et al. Validity and reliability of the caregiver contribution to self-care of heart failure index. J Cardiovasc Nurs. 2013;28:245–55.CrossRefPubMed
66.
Onega LL. Helping those who help others: the Modified Caregiver Strain Index. Am J Nurs. 2008;108:62–9. quiz 69–70.CrossRefPubMed
67.
Thornton M, Travis SS. Analysis of the reliability of the modified caregiver strain index. J Gerontol B Psychol Sci Soc Sci. 2003;58:S127–32.CrossRefPubMed
68.
Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969;9:179–86.CrossRefPubMed
69.
Mariani E, Monastero R, Ercolani S, Rinaldi P, Mangialasche F, Costanzi E, et al. Influence of comorbidity and cognitive status on instrumental activities of daily living in amnestic mild cognitive impairment: Results from the ReGA1 project. Int J Geriatr Psych. 2008;23:523–30.CrossRef
70.
Reichman WE, Fiocco AJ, Rose NS. Exercising the brain to avoid cognitive decline: Examining the evidence. Aging Health. 2010;6:565–84.CrossRef
71.
Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010;152:726–32.CrossRefPubMed
72.
Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148:295–309.CrossRefPubMed
73.
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007;39:175–91.CrossRefPubMed
74.
Rendell PG, Jensen F, Henry JD. Prospective memory in multiple sclerosis. J Int Neuropsychol Soc. 2007;13:410–6.CrossRefPubMed
75.
Rendell PG, Thomson DM. Aging and prospective memory: differences between naturalistic and laboratory tasks. J Gerontol A Biol Sci Med Sci. 1999;54:P256–69.CrossRef
76.
Thompson CL, Henry JD, Withall A, Rendell PG, Brodaty H. A naturalistic study of prospective memory function in MCI and dementia. Br J Clin Psychol. 2011;50:425–34.CrossRefPubMed
77.
Zogg J, Woods S, Sauceda J, Wiebe J, Simoni J. The role of prospective memory in medication adherence: a review of an emerging literature. J Behav Med. 2012;35:47–62.CrossRefPubMed
78.
Foster ER, Rose NS, McDaniel MA, Rendell PG. Prospective memory in Parkinson disease during a virtual week: effects of both prospective and retrospective demands. Neuropsychol. 2013;27:170–81.CrossRef
79.
Kliegel M, Martin M. Prospective memory research: why is it relevant? Int J Psychol. 2003;38:193–4.CrossRef
80.
Paquet L, Collins B, Song X, Chinneck A, Bedard M, Verma S. A pilot study of prospective memory functioning in early breast cancer survivors. Breast. 2013;22:455–61.CrossRefPubMed
81.
Rendell PG, Henry JD, Phillips LH, De La Piedad GX, Booth P, Phillips P, et al. Prospective memory, emotional valence, and multiple sclerosis. J Clin Exp Neuropsychol. 2012;34:738–49.CrossRefPubMed
82.
Flak M, Hernes S, Skranes J, Lohaugen G. The Memory Aid study: protocol for a randomized controlled clinical trial evaluating the effect of computer-based working memory training in elderly patients with mild cognitive impairment (MCI). Trials. 2014;15:156.CrossRefPubMedPubMedCentral
83.
Insel KC, Einstein GO, Morrow DG, Hepworth JT. A multifaceted prospective memory intervention to improve medication adherence: design of a randomized control trial. Contemp Clin Trials. 2013;34:45–52.CrossRefPubMed
84.
Jobe JB, Smith DM, Ball K, Tennstedt SL, Marsiske M, Willis SL, et al. Active: A cognitive intervention trial to promote independence in older adults. Control Clin Trials. 2001;22:453–79.CrossRefPubMedPubMedCentral
85.
Rojas GJ, Villar V, Iturry M, Harris P, Serrano CM, Herrera JA, et al. Efficacy of a cognitive intervention program in patients with mild cognitive impairment. Int Psychogeriatr. 2013;25:825–31.CrossRefPubMed
86.
Cheng Y, Wu W, Feng W, Wang J, Chen Y, Shen Y, et al. The effects of multi-domain versus single-domain cognitive training in non-demented older people: a randomized controlled trial. BMC Med. 2012;10:30.CrossRefPubMedPubMedCentral
87.
Smith GE, Housen P, Yaffe K, Ruff R, Kennison RF, Mahncke HW, et al. A cognitive training program based on principles of brain plasticity: results from the Improvement in Memory with Plasticity-based Adaptive Cognitive Training (IMPACT) study. J Am Geriatr Soc. 2009;57:594–603.CrossRefPubMedPubMedCentral
88.
de Tournay-Jette E, Dupuis G, Denault A, Cartier R, Bherer L. The benefits of cognitive training after a coronary artery bypass graft surgery. J Behav Med. 2012;35:557–68.CrossRefPubMed
89.
Pressler SJ, Martineau A, Grossi J, Giordani B, Koelling TM, Ronis DL, et al. Healthcare resource use among heart failure patients in a randomized pilot study of a cognitive training intervention. Heart Lung. 2013;42:332–8.CrossRefPubMedPubMedCentral
Metadata
Title
PROspective MEmory Training to improve HEart failUre Self-care (PROMETHEUS): study protocol for a randomised controlled trial
Authors
Jan Cameron
Peter G Rendell
Chantal F Ski
Christina E Kure
Skye N McLennan
Nathan S Rose
David L Prior
David R Thompson
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0721-2

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