Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000724976
Ethics application status
Approved
Date submitted
8/07/2011
Date registered
12/07/2011
Date last updated
2/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of a regional, interdisciplinary, student clinic on the health costs and outcomes of people with chronic diseases.
Scientific title
The impact of a regional, interdisciplinary allied health and nursing intervention program for people with chronic disease on health-related quality of life, health costs, and hospital status.
Secondary ID [1] 262594 0
Nil
Universal Trial Number (UTN)
U1111-1122-7301
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Disease 268276 0
Condition category
Condition code
Public Health 268408 268408 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The effect of time, sociodemographic factors, perceived social support, self-reported health, comorbidities, type and length of intervention, and mood and anxiety on health-related quality of life at 3-months, 6-months and 12- months after baseline for chronic disease clients attending the program will be examined. In addition, changes in medical and medication out-of-pocket costs, and hospital status will be compared for the 6 months prior to baseline to the 6-months after baseline.

A diverse range of individualised, interdisciplinary education and exercise therapy programs such as Back School, a Healthy Lifestyle program, and pain management programs; and individualised discipline specific consultations are provided. Sessions vary from 10-15 minutes in length to several hours depending on the clients requirements. The duration of intervention is not set but varies from one patient to another (days to years).
Intervention code [1] 266930 0
Not applicable
Comparator / control treatment
Out-of-pocket medical and medication expenses, and hospital status will be measured for the 6-months prior to baseline and compared to the 6-months after baseline.
Control group
Historical

Outcomes
Primary outcome [1] 269165 0
Health-related quality of life measured using SF-36
Timepoint [1] 269165 0
Baseline, 3-months and 6-months post-baseline.
Primary outcome [2] 269166 0
Health costs will be measured using data from Medicare on medical (including specialists) and medication out-of-pocket expenses.
Timepoint [2] 269166 0
6-month prior to baseline and 6-months after baseline
Primary outcome [3] 269167 0
Hospitalisation status measured using chart data (number of hospitalisations and number of days in hospital)
Timepoint [3] 269167 0
6-months prior to baseline and 6-months after baseline
Secondary outcome [1] 279050 0
Psychological distress or well-being measured using the Kessler6
Timepoint [1] 279050 0
Baseline
Secondary outcome [2] 279051 0
Physical function measured using BMI and the Timed Up and Go test.
Timepoint [2] 279051 0
Baseline
Secondary outcome [3] 279052 0
Self-reported health perception measured using a single question
Timepoint [3] 279052 0
Baseline, 3 months and 6-months post baseline
Secondary outcome [4] 279053 0
Perceived functional and structural social support measured using the MOS social support survey
Timepoint [4] 279053 0
Baseline
Secondary outcome [5] 279054 0
Disease burden/ severity and number of comorbid conditions measured using self-report comorbidity measure by Bayliss
Timepoint [5] 279054 0
Baseline, 3-months, 6-months post-baseline
Secondary outcome [6] 279055 0
Sociodemographics including age, gender, level of education, ethnicity, and employment status will be obtained from chart data.
Timepoint [6] 279055 0
Baseline

Eligibility
Key inclusion criteria
Presence of at least one chronic disease; aged 18 or older; provision of informed consent to participate; attendance at one or more sessions of intervention at the service within 3-months of the intake interview; and attendance at the first intake appointment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe communication disability or behavioural changes that would compromise the ability to participate in the intervention program or complete self-report questionnaires; or, a cognitive deficit that impairs the ability to read and write.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2011
Actual
22/08/2011
Date of last participant enrolment
Anticipated
Actual
28/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
624
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 267402 0
Government body
Name [1] 267402 0
Allied Health Clinical Education and Training Unit
Country [1] 267402 0
Australia
Primary sponsor type
Individual
Name
Dr Zephanie Tyack
Address
Level 2, Allied Health, Rockhampton Base Hospital, Canning St, Rockhampton, Qld 4700.
Country
Australia
Secondary sponsor category [1] 266459 0
None
Name [1] 266459 0
Address [1] 266459 0
Country [1] 266459 0
Other collaborator category [1] 252099 0
Individual
Name [1] 252099 0
Kerrie-Anne Frakes
Address [1] 252099 0
Capricornia Allied Health Partnership
PO Box 501, Rockhampton, Qld 4700
Country [1] 252099 0
Australia
Other collaborator category [2] 252100 0
Individual
Name [2] 252100 0
Petrea Cornwell
Address [2] 252100 0
Metro North (Northern)
Allied Health Research Collaborative
The Prince Charles Hospital, Rode Rd, Chermside, Qld 4032
Country [2] 252100 0
Australia
Other collaborator category [3] 252101 0
Individual
Name [3] 252101 0
Suzanne Kuys
Address [3] 252101 0
Metro North (Northern)
Allied Health Research Collaborative
The Prince Charles Hospital, Rode Rd, Chermside, Qld 4032
Country [3] 252101 0
Australia
Other collaborator category [4] 252102 0
Individual
Name [4] 252102 0
Steven McPhail
Address [4] 252102 0
Allied Health Research Collaborative
The Prince Charles Hospital, Rode Rd, Chermside, Qld 4032
Country [4] 252102 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269372 0
Central Queensland Human Research Ethics Committee
Ethics committee address [1] 269372 0
Ethics committee country [1] 269372 0
Australia
Date submitted for ethics approval [1] 269372 0
21/03/2011
Approval date [1] 269372 0
26/05/2011
Ethics approval number [1] 269372 0
11/QCQ/14

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

Contacts
Principal investigator
Name 32851 0
Dr Zephanie Tyack
Address 32851 0
Level 2, Allied Health Services, Rockhampton Hospital, Canning St, Rockhampton, QLD 4700
Country 32851 0
Australia
Phone 32851 0
+61 7 49207396
Fax 32851 0
Email 32851 0
[email protected]
Contact person for public queries
Name 16098 0
Dr Zephanie Tyack
Address 16098 0
Level 2, Allied Health Services
Rockhampton Base Hospital
Canning St
Rockhampton, QLD 4700
Country 16098 0
Australia
Phone 16098 0
+61 7 49207396
Fax 16098 0
Email 16098 0
[email protected]
Contact person for scientific queries
Name 7026 0
Dr Zephanie Tyack
Address 7026 0
Level 2, Allied Health Services
Rockhampton Base Hospital
Canning St
Rockhampton, QLD 4700
Country 7026 0
Australia
Phone 7026 0
+61 7 49207396
Fax 7026 0
Email 7026 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
SourceTitleYear of PublicationDOI
Dimensions AIThe health outcomes and costs of people attending an interdisciplinary chronic disease service in regional Australia: protocol for a longitudinal cohort investigation2013https://doi.org/10.1186/1472-6963-13-410
N.B. These documents automatically identified may not have been verified by the study sponsor.