Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000558820
Ethics application status
Approved
Date submitted
11/05/2012
Date registered
25/05/2012
Date last updated
25/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of an assessment tool to guide heart failure support
Scientific title
Implementation of a self-care assessment tool to enhance health outcomes among heart failure patients: a modified Solomon 4-group design
Secondary ID [1] 280479 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Heart Failure and patient self-care 286457 0
Condition category
Condition code
Cardiovascular 286715 286715 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study intervention is the application of the screening tool by a CHF nurse clinician. The screening tool assesses physical, cognitive and emotional functioning as key determinants of CHF self-care. For each of the three domains the patient’s level of functioning is quantified as low, medium or high. In this manner, low functioning indicates the individual is at greater risk of inadequate self-care ability and will require more intensive strategies than an individual with high functioning. The screening tool is administered to each participant once only and is administered by the CHF nurse at their first home visit following recruitment to the study. The screening tool takes approximately10 minutes to administer. The screening tool provides the nurse clinician with recommendations on the frequency of contact, symptom monitoring and most appropriate educational and counselling approaches to adopt in promoting and supporting patient self-care. For example, if a patient is screened as ‘low’ self-care ability on the cognitive domain it is recommended that the CHF nurse has weekly contact with the patient via home visits or telephone support. The overall duration of the intervention is 3 months.
Intervention code [1] 284843 0
Early detection / Screening
Intervention code [2] 284937 0
Rehabilitation
Comparator / control treatment
The control group will receive the standard CHF nursing care in accordance with the Eastern HARP guidelines.
Control group
Active

Outcomes
Primary outcome [1] 287109 0
Patients in the intervention groups will have significantly higher self-care maintenance, management and confidence scores from the Self-Care Heart Failure Index.
Timepoint [1] 287109 0
At 3 and 6 months
Primary outcome [2] 287110 0
Patients in the intervention groups will have significantly higher medication adherance scores
Timepoint [2] 287110 0
At 3 and 6 months
Secondary outcome [1] 297390 0
Health related quality of life (SF-12)
Timepoint [1] 297390 0
At baseline and at 3 and 6 months post intervention commencement
Secondary outcome [2] 297391 0
All-cause hospitalisation and death
Timepoint [2] 297391 0
At 3 and 6 months post intervention commencement

Eligibility
Key inclusion criteria
Participants will be 18 years of age or older and have a confirmed diagnosis of CHF. Confirmation of the diagnosis will be from: 1) symptoms and clinical features of congestion that occur at rest or on minimal effort (dyspnoea, orthopnea, paroxysmal nocturnal dyspnoea, fatigue, palpitations, elevated jugular venous pressure, cardiomegaly, lung crepitations, hepatomegaly, oedema); 2) either objective evidence of underlying structural cardiac dysfunction that impairs the ability of the ventricle to fill with or eject blood or an elevated plasma level of B-type natriuretic Peptide (BNP), >200 pg/mL. Participants will have been referred and enrolled into the CHFMP which is conducted across Eastern health.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient participants will be excluded if they reside in a residential aged high care facility (nursing home), have a documented history of moderate-to-severe cognitive impairment or dementia, or have a terminal diagnosis. Participants who do not have sufficient comprehension to read English without the need of a translator will be excluded.

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)
All patients who meet the study criteria and are enrolled into a CHF management program (CHFMP) across Eastern Health will be approached and recruited over a 16 month time period. A research associate (RA) working closely with the CHF nurses will screen and recruit participants. Once participants have consented to the study a detailed history will be collected by the RA and pre-test assessments conducted. Each CHFMP program (Box Hill, Maroondah and Angliss) has been randomly assigned to a group and sequence of testing as outlined below (other design features). Participants are allocated to the respective study group according to the location of the CHFMP (Box Hill, Maroondah or Angliss hospitals). The RA will notify the respective CHF nurses of participants recruited. The CHF nurses at the Angliss and BoxHill hospitals will administer the screening tool during their first home visit and use the recommendations to develop an individualised nursing care plan. Participants who are recruited into the Maroondah CHFMP will have the self-care screening tool administered by the RA. In this manner, the Maroondah nurse clinicians are concealed of their patients screening and level of functioning.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation of the hospitals to the respective intervention or control groups was determined by the name of each hospital being drawn randomly and then the study group allocation was drawn randomly
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This study is a modified Solomon 4-group design. Each CHFMP program has been randomly assigned to a group and sequence of testing as outlined below:
Angliss: Pre-testing - Intervention - 3 and 6 month post-testing
BoxHill: No pre-testing - Intervention - 3 and 6 month post-testing
Maroondah: Pre-testing - No intervention - 3 and 6 month post-testing
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5278 0
3128
Recruitment postcode(s) [2] 5279 0
3125
Recruitment postcode(s) [3] 5280 0
3134
Recruitment postcode(s) [4] 5281 0
3133
Recruitment postcode(s) [5] 5282 0
3130
Recruitment postcode(s) [6] 5283 0
3129
Recruitment postcode(s) [7] 5284 0
3180
Recruitment postcode(s) [8] 5285 0
3754
Recruitment postcode(s) [9] 5286 0
3149
Recruitment postcode(s) [10] 5287 0
3796
Recruitment postcode(s) [11] 5288 0
3140
Recruitment postcode(s) [12] 5289 0
3155

Funding & Sponsors
Funding source category [1] 285231 0
Charities/Societies/Foundations
Name [1] 285231 0
Nurses Board Legacy LTD
Country [1] 285231 0
Australia
Funding source category [2] 285232 0
University
Name [2] 285232 0
Australian Catholic University
Country [2] 285232 0
Australia
Primary sponsor type
University
Name
Cardiovascular Research Centre/ Australian Catholic University
Address
Level 4, 486 Albert Street, East Melbourne, Vic 3002
Country
Australia
Secondary sponsor category [1] 284099 0
None
Name [1] 284099 0
Address [1] 284099 0
Country [1] 284099 0
Other collaborator category [1] 260796 0
Hospital
Name [1] 260796 0
Eastern Health
Address [1] 260796 0
Nelson Street, Box Hill, Vic 3128
Country [1] 260796 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287242 0
Eastern Health
Ethics committee address [1] 287242 0
Ethics committee country [1] 287242 0
Australia
Date submitted for ethics approval [1] 287242 0
25/01/2012
Approval date [1] 287242 0
07/02/2012
Ethics approval number [1] 287242 0
LR39-1112
Ethics committee name [2] 287243 0
Australian Catholic University
Ethics committee address [2] 287243 0
Ethics committee country [2] 287243 0
Australia
Date submitted for ethics approval [2] 287243 0
07/02/2012
Approval date [2] 287243 0
09/02/2012
Ethics approval number [2] 287243 0
2012 04V

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

Contacts
Principal investigator
Name 34169 0
Address 34169 0
Country 34169 0
Phone 34169 0
Fax 34169 0
Email 34169 0
Contact person for public queries
Name 17416 0
Dr Jan Cameron
Address 17416 0
Level 4, 486 Albert Street,
East Melbourne
Vic 3002
Country 17416 0
Australia
Phone 17416 0
+61 3 99533698
Fax 17416 0
Email 17416 0
[email protected]
Contact person for scientific queries
Name 8344 0
Dr Jan Cameron
Address 8344 0
Level 4, 486 Albert Street,
East Melbourne
Vic 3002
Country 8344 0
Australia
Phone 8344 0
+ 61 3 99533698
Fax 8344 0
Email 8344 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.