Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000575639
Ethics application status
Approved
Date submitted
21/05/2014
Date registered
29/05/2014
Date last updated
13/07/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
PROspective MEmory Training to improve HEart failUre Self-care: a randomised controlled trial
Scientific title
The effectiveness of prospective memory training in heart failure patients to improve self-care
Secondary ID [1] 284636 0
Nil
Universal Trial Number (UTN)
U1111-1157-1054
Trial acronym
PROMETHEUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prospective memory 291951 0
Heart failure 291953 0
Condition category
Condition code
Cardiovascular 292301 292301 0 0
Coronary heart disease
Mental Health 292350 292350 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Restorative memory training (Virtual Week)
HF patient participants randomly allocated to receive the computer based restorative memory training strategy (Virtual Week), will be contacted by a research assistant (RA) who is blinded to their baseline neuro-psychological assessment. The RA will organize to meet face-face with the HF patient participant at a convenient time at their home or a clinic, to begin the training. It is anticipated the first training session will take 40-45 mins. At the training session the patient participant will be provided with a USB version of Virtual Week to use on their home computer over six weeks. They will be advised to use the training program four times per week over six weeks. Each training session will take approximately 20 to 30 minutes to complete each day. On insertion of the USB into the participant’s computer, it will bring up prompts to begin the training at the appropriate level and limit the number of sessions that can be completed on each day. The training version of Virtual Week has the critical factor of adaptive difficulty where the task starts at a relatively easy level and then is progressively more difficult, adapting to the performance level achieved by the participant. Another key feature of this program is the distributed practice of the cognitive training, in this case over six weeks, rather than massed practice in one or two long sessions. A final key training feature, is that Virtual Week has provision to provide feedback at the conclusion of each 'virtual day' (which will occur twice per session) so that participants are aware of their performance on each day and of their progression through the difficulty levels. The program also has provision to record performance. At the first training session the RA will provide face-to-face support to the patient participant in using the computer program. An automatic emailing system will also be set up by the RA to send participant's training data automatically at the completion of each session so that the participant’s involvement in the restorative memory training program can be monitored. In addition, the RA will make contact with participants by telephone twice a week to offer support and monitor progress. The RA will also be accessible to participants by telephone four days a week, during business hours to answer queries or resolve issues relating to the program. Face-to-face support will be arranged where needed. After six weeks of using the memory training program the RA will arrange for the USB to be returned.
Intervention code [1] 289423 0
Treatment: Other
Intervention code [2] 289453 0
Behaviour
Comparator / control treatment
Heart failure usual care with sham (non-adaptive puzzle training).
HF patient participants randomly allocated to sham will continue to receive their usual care from service providers, this may be from any combination of nurse-led chronic disease management programs, specialized HF outpatient clinics, or outpatient rehabilitation programs. To control for the social and participatory features of the restorative training, participants will be asked to complete a set of puzzles, for a similar amount of time to the restorative memory training condition; that is they will be asked to spend 20-30 mins per day completing a set of puzzles, four times per week, over six weeks. The puzzles are non-adaptive in the difficulty level of the tasks. The participants in the control arm will have face-to-face contact with the RA to introduce them to the puzzle training and will also have telephone contact twice/week with the RA to monitor their participation in the cross word puzzle training. They will also be able to contact the RA by telephone during business hours four days a week with any questions or issues related to the puzzles. Face-to-face support will be arranged where needed.
Control group
Placebo

Outcomes
Primary outcome [1] 292173 0
Self-care as assessed by the Self-Care Heart Failure Index (SCHFI)
Timepoint [1] 292173 0
Baseline, and at 3 and 12 months after intervention commencement
Secondary outcome [1] 308357 0
Unplanned hospital readmissions will be collected by a short questionnaire sent to participants.
Timepoint [1] 308357 0
At 3 and 12 months after after intervention commencement
Secondary outcome [2] 308358 0
The neuro-psychological assessment will compromise of:
1. Global cognitive screen using the Addenbrooke’s Cognitive Examination Revised (ACE-R)
2. Executive functioning using a battery of tests from the CogState program (the One Back Task , the Two Back Task, the Detection Task, the One Card Learning Task). In addition pen and paper tasks using the Trail Making Test Part A and B.
3. Verbal memory using the Hopkins Verbal Learning Test-Revised (HVLT)
4. Prospective memory (PM) using the Memory for Intentions Screening Test (MIST
5. Premorbid intelligence using the The National Adult Reading Test (NART)
6. Instrumental Activities of Daily Living will be assessed using a modified version of the Timed Independent Activities of Daily Living (TIADL).
Timepoint [2] 308358 0
Baseline, and at 3 and 12 months after after intervention commencement

Eligibility
Key inclusion criteria
HF patient participant: Diagnosis of heart failure confirmed by cardiologist and Australian guidelines; Attending either a heart failure clinic or disease management program; Access to a PC and having basic PC skills

60 Control participants will be matched by age, gender and education level to HF patient participants. Inclusion criteria: living independently in the community; have no medical diagnosis of HF on self-report; adequate performance on the Addenbrooke's Cognitive Examination Revised (ACE-R)

Care participants will be identified by the Heart Failure participants; They must be able and willing to answer questions, they have not have a documented history of moderate to severe cognitive impairment or dementia; have not have a terminal diagnosis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
HF patient participant: Inadequate vision, hearing or English comprehension; Receiving long-term residential care; Documented history of moderate to severe cognitive impairment; a myocardial infarction, stroke or cardiac surgery in previous 3 months.
Healthy controls: residing in a long-term high care facility (nursing home); moderate-to-severe cognitive impairment or dementia, a self-reported cardiac event within the past six months (cerebrovascular accident, acute myocardial infarction or cardiac surgery).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Using CONSORT principles, participants will be randomly allocated to one of the two study interventions (usual care or memory training in addition to usual care). Block randomisation by a computer generated number list will be prepared centrally by an investigator with no involvement in data collection. Allocation will be concealed using central randomisation by computer and contacting the holder of the allocation schedule who will be off-site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation with a 1:1 ratio will be used to keep the two groups of similar sizes. Once the patient has consented to the study and baseline measures have been collected the research assistant will contact one of the study investigators who are independent of the recruitment process and data collection, for allocation consignment. The research assistant collecting the baseline measures will not be informed of the participant’s assignment, instead the research assistant conducting the cognitive training will be notified when a patient participant has been randomised to this intervention.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To compare prospective memory outcomes heart failure patients and healthy matched controls, group differences in baseline prospective memory and neuropsychological tests will be examined using inferential statistics (t-test and ANOVA).
Multiple regression analysis will examine which independent variables are significant predictors of heart failure self-care.
To examine if memory training improves functional outcomes among heart failure patients, we will use ANCOVA to adjust for baseline values and examine for statistically and clinically significant differences in self-care and all-cause readmissions.
Based on data from other relevant trials of patient education and heart failure self-care, an 8-point difference in standardized self-care scores is a clinically important change and it has been estimated that sample sizes of 63 per group have 80% power at 0.05 significance, in detecting a small to medium effect of the intervention on hospitalisations. For this study, sample size calculations were determined using G*power calculator. Using ANCOVA to examine for clinically significant differences in standardized self-care maintenance and management scores between the two HF groups, a total of 100 patients in each group (200 in total) will have >90% power (alpha of 0.05) to detect a medium effect size ('f^2 =.4) in the primary endpoint. The probable requirement to undertake non-parametric statistical analyses (due to non-Gaussian distributed data) has been factored into study power calculations in addition to a 20% intervention refusal rate and loss to follow-up.

The sample size for the comparison of baseline cognitive performance (in particular PM) between 60 HF patients and a healthy age-matched control group has been based on previous studies by CI Rendell. As such, the sample size has the power to show that a large effect size >=1.0 SD is significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/06/2014
Actual
31/07/2014
Date of last participant enrolment
Anticipated
16/06/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
260
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2479 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 2480 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [3] 4034 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 4035 0
The Alfred - Prahran
Recruitment postcode(s) [1] 8132 0
3065 - Fitzroy
Recruitment postcode(s) [2] 8133 0
3144 - Malvern
Recruitment postcode(s) [3] 9949 0
3128 - Box Hill
Recruitment postcode(s) [4] 9950 0
3181 - Prahran

Funding & Sponsors
Funding source category [1] 289262 0
Government body
Name [1] 289262 0
Australian Government's Collaborative Research Networks Program
Country [1] 289262 0
Australia
Funding source category [2] 289263 0
Charities/Societies/Foundations
Name [2] 289263 0
National Heart Foundation
Country [2] 289263 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
115 Victoria Parade
Fitzroy
VIC 3065
Country
Australia
Secondary sponsor category [1] 287937 0
None
Name [1] 287937 0
Address [1] 287937 0
Country [1] 287937 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291035 0
St Vincent's Human Research Ethics Committee
Ethics committee address [1] 291035 0
Ethics committee country [1] 291035 0
Australia
Date submitted for ethics approval [1] 291035 0
Approval date [1] 291035 0
17/04/2014
Ethics approval number [1] 291035 0
HREC-A 018/14

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48562 0
Prof David R Thompson
Address 48562 0
Mary Mackillop Institute for Health Research Level 5, 215, Spring Street, Melbourne, VIC 3000
Country 48562 0
Australia
Phone 48562 0
+613 9953 3680
Fax 48562 0
Email 48562 0
[email protected]
Contact person for public queries
Name 48563 0
Jan Cameron
Address 48563 0
Mary Mackillop Institute for Health Research Level 5, 215, Spring Street, Melbourne, VIC 3000
Country 48563 0
Australia
Phone 48563 0
+613 9953 3698
Fax 48563 0
Email 48563 0
[email protected]
Contact person for scientific queries
Name 48564 0
Jan Cameron
Address 48564 0
Mary Mackillop Institute for Health Research Level 5, 215, Spring Street, Melbourne, VIC 3000
Country 48564 0
Australia
Phone 48564 0
+613 9953 3698
Fax 48564 0
Email 48564 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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