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

Cameron J, Rendell PG, Ski CF, Kure CE, McLennan SN, Rose NS, Prior DL, Thompson DR - Trials (2015)

Bottom Line: Cognitive impairment is seen in up to three quarters of heart failure (HF) patients and has a significant negative impact on patients' health outcomes.Assessments will take place at baseline, 4 weeks and 12 months following intervention.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.

View Article: PubMed Central - PubMed

Affiliation: Centre for the Heart and Mind, Mary MacKillop Institute for Health Research, Australian Catholic University, Level 5, 215 Spring Street, Melbourne, VIC, 3000, Australia. jan.cameron@acu.edu.au.

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 .

No MeSH data available.


Related in: MedlinePlus

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.
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Fig1: 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.

Mentions: Using CONSORT principles [71] HF patients will be randomised to 1 of the 2 study interventions: 1) usual care plus PM training (see Figure 1) or 2) active control group. Block randomisation will be allocated via a computer generated number prepared by an investigator with no involvement in data collection. Block randomisation with 1:1 ratio will be used to keep the 2 groups at similar sizes. Once the HF patient has consented to the study and baseline measures have been collected the research assistant will contact one of the training study investigators, who are independent of the recruitment process and data collection, for allocation consignment. Research assistants collecting baseline measures will not be informed of the patient’s assignment. Instead, the research assistant conducting the cognitive training will be notified when a patient has been randomised to this intervention. Participants enrolled in the study will be aware of the training activity they have been allocated and therefore they will not be blinded to the treatment allocation.Figure 1


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

Cameron J, Rendell PG, Ski CF, Kure CE, McLennan SN, Rose NS, Prior DL, Thompson DR - Trials (2015)

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.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4419391&req=5

Fig1: 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.
Mentions: Using CONSORT principles [71] HF patients will be randomised to 1 of the 2 study interventions: 1) usual care plus PM training (see Figure 1) or 2) active control group. Block randomisation will be allocated via a computer generated number prepared by an investigator with no involvement in data collection. Block randomisation with 1:1 ratio will be used to keep the 2 groups at similar sizes. Once the HF patient has consented to the study and baseline measures have been collected the research assistant will contact one of the training study investigators, who are independent of the recruitment process and data collection, for allocation consignment. Research assistants collecting baseline measures will not be informed of the patient’s assignment. Instead, the research assistant conducting the cognitive training will be notified when a patient has been randomised to this intervention. Participants enrolled in the study will be aware of the training activity they have been allocated and therefore they will not be blinded to the treatment allocation.Figure 1

Bottom Line: Cognitive impairment is seen in up to three quarters of heart failure (HF) patients and has a significant negative impact on patients' health outcomes.Assessments will take place at baseline, 4 weeks and 12 months following intervention.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.

View Article: PubMed Central - PubMed

Affiliation: Centre for the Heart and Mind, Mary MacKillop Institute for Health Research, Australian Catholic University, Level 5, 215 Spring Street, Melbourne, VIC, 3000, Australia. jan.cameron@acu.edu.au.

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 .

No MeSH data available.


Related in: MedlinePlus