Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000421639
Ethics application status
Approved
Date submitted
14/03/2014
Date registered
17/04/2014
Date last updated
20/05/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of a nurse-led, community-based heart failure management service on self-management behaviour and psychosocial outcomes.
Scientific title
The impact of a nurse-led community-based heart failure management service (SmartHeart) on self-management behaviour and psychosocial outcomes in elderly patients
Secondary ID [1] 283893 0
nil known
Universal Trial Number (UTN)
U1111-11520637
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart failure 290879 0
self management 290880 0
Condition category
Condition code
Cardiovascular 291237 291237 0 0
Other cardiovascular diseases
Public Health 291794 291794 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SmartHeart Living Well with Heart Failure service aims to improve the quality of lives of HF patients and reduce hospital admissions by providing patients with community-based clinical support. The service commenced at Curtin University, through its Interprofessional Health and Wellness Clinics, in April 2013. The SmartHeart program is led by a nurse practitioner who provides monitoring for HF patients through comprehensive patient assessment, regular liaison with General Practitioners, medical specialists or local service providers, coaching in self-management strategies and healthy lifestyle behaviours including individualized educational plan including dietary advice and weight monitoring. Nurses will also assist patients to access community related services including psychological support and exercise programs. Participants consult with nurse practitioner whenever necessary. Participants are required to attend once off meeting with data collector (principal investigator) that will be one-to one and the meeting will be less than 60 minutes. The purpose of the study and the details of the 3 questionnaires (SCHFI, MLWHFQ, SF 36) will to be explain to the participants and the participants are required to answer the 3 questionnaires.
Intervention code [1] 288568 0
Other interventions
Comparator / control treatment
Participants are required to attend once off meeting with data collector (principal investigator) that will be one-to one and the meeting will be less than 60 minutes. Both groups will to be explain the purpose of the study and the control group will be notified that they do not receive any intervention from SmartHeart.
Control group
Active

Outcomes
Primary outcome [1] 291234 0
self management behaviour through self-care heart failure index (SCHFI)
Timepoint [1] 291234 0
once only at any time between 6-12 months post discharge
Primary outcome [2] 291719 0
psychosocial outcomes through Minnesota Living with Heart Failure Questionnaire and SF36
Timepoint [2] 291719 0
once only at any time between 6-12 months post discharge
Secondary outcome [1] 307506 0
nil
Timepoint [1] 307506 0
nil

Eligibility
Key inclusion criteria
primary or secondary diagnosis of heart failure
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
unable to consent
terminal illnesses
significant cognitive impairment
physical inability to engage in self-care behaviours

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics (percentage, mean, and standard deviation) will be used to portray characteristics of the experimental group (receiving community-based HF management) and control group according to demographic and clinical information. Categorized variables will include ethnicity, education, occupational status, socioeconomic status, social support, HF severity and comorbidities. A comparison of baseline characteristics of participants enrolling in the intervention versus the control group will be undertaken using independent T-tests.
A mixed model analysis of self-care behaviours at 6-12 months post HF admission is proposed. This will use admitting hospital as a covariate. The treatment effect estimate will be ‘the difference between participants and controls at 6-12 months, adjusting for admitting hospital so any imbalance between groups will be minimized. If there are demographic or clinical factors that are imbalanced between groups and highly associated with outcome, these will also be included in the model.

Independent sample t-test will be used to test for significant differences in HF self-care behaviors and measures of quality of life between participants in the experimental and control groups. Pearson r correlation coefficient will be used to determine the relationship between the provision or community-based HF management, and other variables, with self-care behaviours and quality of life.

Sample size calculation:
Based on previous HF study, to detect a 12-point difference in physical function on the Short Form-36 with standard deviation of 20 points, it is estimated a sample size of 59 per group is needed with a 2-sided 5% significance level and 90% power. When taking into account a loss of to follow up of 10%, 130 participants (65 per group) will be required.


Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/05/2014
Actual
1/05/2014
Date of last participant enrolment
Anticipated
Actual
30/11/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 2186 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 2187 0
Fremantle Hospital and Health Service - Fremantle

Funding & Sponsors
Funding source category [1] 288891 0
University
Name [1] 288891 0
Curtin University
Country [1] 288891 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent St, Bentley, Western Australia 6102
Country
Australia
Secondary sponsor category [1] 287588 0
None
Name [1] 287588 0
Address [1] 287588 0
Country [1] 287588 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290720 0
HREC Curtin University
Ethics committee address [1] 290720 0
Kent St, Bentley, Western Australia 6102
Ethics committee country [1] 290720 0
Australia
Date submitted for ethics approval [1] 290720 0
Approval date [1] 290720 0
14/12/2013
Ethics approval number [1] 290720 0
HR12/2014

Summary
Brief summary
Heart failure is a disorder where right or left ventricular function is affected and the heart fails to pump blood efficiently around the body. The purpose of this study is to identify whether a nurse-led, community based heart failure management service (SmartHeart) improves self-management and quality of life. Participants in the study will be patients with a recent hospital admission due to heart failure as a primary or secondary diagnosis who are less than 85 years of age. The experimental group will compromise patients who are admitted to a tertiary hospital with links to a community-based heart failure management service and subsequently referred to that service. The control group will be comprised of a similar cohort of patients, matched for gender, age and functional class who are admitted to a different tertiary hospital without links to a community-based heart failure management service. The Self-Care Heart Failure Index (SCHFI) will be utilized to measure self-management behaviours and self-efficacy. Quality of life will be determined using the Short Form 36 and Minnesota Living with Heart Failure Questionnaire. The findings from this study will help guide evidence-based practice for nurse-led management of heart failure in the sub-acute period.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45486 0
Miss Sheau Huey Chen
Address 45486 0
Curtin University
Kent St, Bentley,
Western Australia 6102
Country 45486 0
Australia
Phone 45486 0
(+614) 30161252
Fax 45486 0
Email 45486 0
[email protected]
Contact person for public queries
Name 45487 0
Andrew Maiorana
Address 45487 0
Curtin University
Kent St, Bentley,
Western Australia 6102
Country 45487 0
Australia
Phone 45487 0
(+618) 9266 9225
Fax 45487 0
Email 45487 0
[email protected]
Contact person for scientific queries
Name 45488 0
Andrew Maiorana
Address 45488 0
Curtin University
Kent St, Bentley,
Western Australia 6102
Country 45488 0
Australia
Phone 45488 0
(+618) 9266 9225
Fax 45488 0
Email 45488 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.