Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000423415
Ethics application status
Approved
Date submitted
15/08/2007
Date registered
22/08/2007
Date last updated
22/08/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Health Improvement and Prevention Study
Scientific title
A randomized controlled trial of a general practice based intervention to prevent chronic vascular disease
Secondary ID [1] 459 0
Nil
Universal Trial Number (UTN)
Trial acronym
HIPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vascular disease,
Diabetes Mellitus,
Coronary Heart Disease,
Hypertension
Obesity
Stress 2260 0
Condition category
Condition code
Cardiovascular 2350 2350 0 0
Hypertension
Metabolic and Endocrine 2351 2351 0 0
Diabetes
Mental Health 2352 2352 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project will be conducted as a randomized controlled trial with randomisation at the level of practices. After baseline data collection from 32 practices and their staff, practices will be randomized into the intervention or the control group (16 in each group). The intervention will be undertaken by the researchers for the practices, and by clinician, for the patients (health check).


METHOD:
Six-month intervention driven by the Project officers from the Divisions will provide support to participating practices to implement the health check. The intervention will focus on :
1) Clinician awareness and use of motivational interviewing/stages of change to provide appropriate brief interventions during the health check
2) Clinical staff awareness of 5A’s and opportunities for intervention.
3) Patients requiring follow up with the GP are either recalled to the practice by a systematic method, or are provided with their next appointment at the time of consultation.
4) Regular and comprehensive assessment and monitoring is carried out;
5) A systematic approach to maintaining patient registers;
6) Comprehensive recording of SNAP (S= quit Smoking, N=better Nutrition, A=moderate Alcohol, P=more Physical activity) risk factors and interventions in a searchable electronic format;
7) Maintaining an up-to-date directory of linkages with health professionals or organisations for SNAP-related referrals, and a systematic approach for updating this;
8) A systematic approach to providing patient education and resources (paper or electronic);
9) Practice support by identification the potential for expansion of the roles and responsibilities of non-GP staff to support prevention and strategies to do this;
10) Practice support in billing systems which include the health check
Intervention code [1] 1972 0
Prevention
Intervention code [2] 1973 0
Lifestyle
Intervention code [3] 1974 0
Behaviour
Comparator / control treatment
Control group will commence intervention at the conclusion of the study. The facilitators for this will be based in the Divisions.
Control group
Active

Outcomes
Primary outcome [1] 3248 0
Primary Outcome 1: Change in Patient's absolute risk of cardiovascular disease.
Timepoint [1] 3248 0
baseline, 6 months, and 12 months
Primary outcome [2] 3249 0
Primary Outcome 2: Change in single behavioural (Smoking, Diet, Physical Activity) and physiological risk factors (Blood pressure, Total Cholesterol)
Timepoint [2] 3249 0
baseline, 6 months, and 12 months
Primary outcome [3] 3250 0
Primary Outcome 3: Change in Preventive Care received (assessment of behavioural risk factors, blood pressure, fasting lipids,fasting blood glucose) over previous 6 months
Timepoint [3] 3250 0
baseline, 6 months, and 12 months
Secondary outcome [1] 5412 0
Secondary Outcome 1: Change in patient assessed access and patient centredness of primary care using General Practice Assessment Questionnaire (GPAQ)
Timepoint [1] 5412 0
baseline, 6 months, and 12 months
Secondary outcome [2] 5413 0
Secondary Outcome 2: Change in capacity of general practices to provide preventive care (appointment systems, information systems, team roles)
Timepoint [2] 5413 0
6 months, and 12 months
Secondary outcome [3] 5414 0
Secondary Outcome 3: Change in patient psychosocial stress measured by the K10 questionnaire.
Timepoint [3] 5414 0
baseline, and 12 months

Eligibility
Key inclusion criteria
General Practices will be eligible to participate if they use computer-based medical records, are not currently involved in other research, and are located in the participating Divisions of General Practice. Patients in participating practices will be eligible for inclusion in the study if they are aged 45-65 years and have History of Gestational Diabetes (GDM), “Pre diabetes” – impaired glucose tolerance or impaired fasting glycaemia, or elevated blood pressure (or on treatment for high blood pressure) or high cholesterol (or on treatment for cholesterol), Overweight (BMI >28 or waist circumference >102 in males and >88 in females), and current smoker.
Minimum age
45 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients are excluded if they (i) have current severe illness or personal circumstances which are of overriding concern (ii) are deceased (iii) are no longer a patient of the practice (iv) have diabetes or cardiovascular disease (v) are unlikely to be able to read and understand the information sheet and consent form

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After baseline data collection on the practices and their staff, practices will be randomized into the intervention or the control group (cluster randomiization of practices to early or delayed intervention). A university of NSW staff member not linked to the study data collection will perform the randomisation. Project officers and staff collecting data will be blinded to randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block design will be used to randomise participating practices into intervention and control groups. Practices within each division of general practice will constitute one block. The aim is to recruit 4-8 practices within each participating division of general practice.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 218 0
Eastern Sydney: 2000, 2008, 2010, 2011, 2012, 2021, 2022, 2023, 2025, 2056, 2027, 2028, 2029, 2030
Recruitment postcode(s) [2] 219 0
South Eastern Sydney: 2015, 2017, 2018, 2019, 2020, 2024, 2031, 2032, 2033, 2034, 2035, 2036, 2052
Recruitment postcode(s) [3] 220 0
Central Sydney: 2001, 2006, 2007, 2008, 2009,2015, 2016, 2017, 2037, 2038, 2039, 2040, 2041, 2042,2043, 2044, 2045, 2046, 2047, 2048, 2049, 2050,2127, 2128, 2129, 2130, 2131, 2132,2133, 2134, 2135, 2136, 2137, 2138, 2139, 2140, 2203, 2204
Recruitment postcode(s) [4] 221 0
Northern Rivers: 2463, 2464, 2465, 2466, 2469, 2470, 2471, 2472, 2473, 2474, 2475, 2476, 2477, 2478, 2479, 2480, 2481, 2482, 2483
Recruitment postcode(s) [5] 222 0
Dubbo Plains: 2357, 2395, 2396, 2820, 2821, 2823, 2824, 2825, 2827, 2828, 2829, 2830, 2831, 2842, 2843, 2844, 2850, 2852, 2869

Funding & Sponsors
Funding source category [1] 2512 0
Government body
Name [1] 2512 0
National Health and Medical Research Council (NHMRC)
Country [1] 2512 0
Australia
Primary sponsor type
University
Name
University of New South Wales (UNSW)
Address
School of Public Health and Community Medicine, UNSW
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 2278 0
University
Name [1] 2278 0
University of Sydney
Address [1] 2278 0
Corrindah Court
PO Box 457
Broken Hill NSW 2880
Country [1] 2278 0
Australia
Other collaborator category [1] 6 0
Other Collaborative groups
Name [1] 6 0
Central Sydney Division of General Practice
Address [1] 6 0
Level 1, 381 Liverpool Rd
Ashfield NSW 2131
Country [1] 6 0
Australia
Other collaborator category [2] 7 0
Other Collaborative groups
Name [2] 7 0
South East Sydney Division of General Practice
Address [2] 7 0
6-8 Crewe Place
Roseberry NSW 2018
Country [2] 7 0
Australia
Other collaborator category [3] 8 0
Other Collaborative groups
Name [3] 8 0
Eastern Sydney Division of General Practice
Address [3] 8 0
Suit 103, Level1, 35 Spring St
Bondi Junction NSW 2022
Country [3] 8 0
Australia
Other collaborator category [4] 9 0
Other Collaborative groups
Name [4] 9 0
Dubbo/Plains Division of General Practice
Address [4] 9 0
PO Box 1834
Dubbo NSW 2830
Country [4] 9 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4428 0
UNSW Ethic Committee
Ethics committee address [1] 4428 0
Ethics committee country [1] 4428 0
Australia
Date submitted for ethics approval [1] 4428 0
Approval date [1] 4428 0
06/03/2007
Ethics approval number [1] 4428 0
HREC 07023

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

Contacts
Principal investigator
Name 27986 0
Address 27986 0
Country 27986 0
Phone 27986 0
Fax 27986 0
Email 27986 0
Contact person for public queries
Name 11143 0
Professor Mark Harris
Address 11143 0
School of Public Health and Community Medicine, UNSW
Sydney NSW 2052
Country 11143 0
Australia
Phone 11143 0
+61 2 9385 2511
Fax 11143 0
+61 2 9313 6185
Email 11143 0
[email protected]
Contact person for scientific queries
Name 2071 0
Professor Mark Harris
Address 2071 0
School of Public Health and Community Medicine, UNSW
Sydney NSW 2052
Country 2071 0
Australia
Phone 2071 0
+61 2 9385 2511
Fax 2071 0
+61 2 9313 6185
Email 2071 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
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Documents added automatically
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