Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613001241729
Ethics application status
Approved
Date submitted
7/11/2013
Date registered
12/11/2013
Date last updated
12/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of an interdisciplinary, student clinic on the functioning, disability, health and economic outcomes of people with chronic disease in regional Australia.
Scientific title
The impact of an interdisciplinary, student clinic on the functioning, disability, health and economic outcomes of people with chronic disease in regional Australia compared to an oral health student clinic for people with chronic disease.
Secondary ID [1] 282582 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
People with chronic disease (e.g., diabetes, arthritis, heart disease, COPD, asthma, low back pain) 289273 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290842 290842 0 0
Other physical medicine / rehabilitation
Public Health 290851 290851 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Assessment and treatment at a student-led interdisciplinary clinic program including medication management, interdisciplinary care, case management, functional ability assessment and treatment for chronic disease in addition to usual medical magagement and hospital intervention (if applicable).

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 less than 12-months but varies from one patient to another.
Intervention code [1] 287247 0
Rehabilitation
Comparator / control treatment
Assessment and treatment at a student-led oral health clinic in addition to usual medical management and hospital intervention (if applicable).


A range of interventions are provided by oral health students under the supervision of a qualified oral health therapist including hygiene instruction, preventative treatment (e.g., fissure sealing), and treating demineralised areas, mild to moderate periodontitis, and gingivitis. Each appointment is for up to 90 minutes with each course of care usually involving up to 4 appointments. Patients may be recalled on a 3, 6 or 12 month basis depending on the needs of the patient.
Control group
Active

Outcomes
Primary outcome [1] 289687 0
Health measured using the SF-36
Timepoint [1] 289687 0
Baseline, 3-months, and 6-months post-baseline
Secondary outcome [1] 303015 0
Hospital utilisation including number of days of hospitalisation and length of hospitalisation measured using a review of patient health records.
Timepoint [1] 303015 0
Baseline, 3-months, and 6-months post-baseline
Secondary outcome [2] 304756 0
Health care costs including PBS and Medicare data
Timepoint [2] 304756 0
Baseline, 3-months, and 6-months post-baseline.
Secondary outcome [3] 305473 0
Health literacy as measured using the Health Literacy Questionnaire
Timepoint [3] 305473 0
Baseline, 3-months, and 6-months post-baseline.

Eligibility
Key inclusion criteria
Presence of two or more chronic diseases;
Patients aged 18 years or older;
Patients referred to the interdisciplinary student clinic (intervention group only);
Patients referred to the oral health student clinic (control group only)
Attendance at a minimum of four sessions of intervention at the interdisciplinary student clinic within 6-months of the intake interview (intervention group only);
Attendance at a minimum of one or more sessions of intervention at the student-led oral health clinic within 6-months of their initial appointment (control group only); and,
Provision of informed consent to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clients younger than 18 years;
Severe communication disability or behavioural changes that would compromise the ability to participate in the intervention program or complete the questionnaires;
A cognitive deficit that impairs the ability to read or write or be interviewed.

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



The people analysing the results/data
Intervention assignment
Parallel
Other design features
intention-to-treat analysis
matching of subjects in the intervention and control group
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to describe the outcome variables and covariates. Confidence intervals will also be presented for outcome variables and predictors.

Regression models for repeated measures will be used to examine the effect of time, group and predictor variables (including intervention variables) on the outcome variables. The importance of the observed change in outcome measures will be determined by comparing the minimal detectable change to the minimally clinical important difference. Individual growth curves will also be used to examine changes in the outcome measures.




Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/11/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
260
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 7535 0
4701 - Central Queensland University

Funding & Sponsors
Funding source category [1] 287361 0
Government body
Name [1] 287361 0
Central Queensland Hospital and Health Service
Country [1] 287361 0
Australia
Primary sponsor type
Government body
Name
Central Queensland Hospital and Health Service
Address
2-8 Canning St, Rockhampton, QLD 4700.
Country
Australia
Secondary sponsor category [1] 286720 0
Government body
Name [1] 286720 0
Metro South Hospital and Health Service
Address [1] 286720 0
PO Box 4043, Eight Mile Plains QLD 4113 Australia
Country [1] 286720 0
Australia
Secondary sponsor category [2] 286721 0
Government body
Name [2] 286721 0
Metro North Hospital and Health Service
Address [2] 286721 0
PO Box 150 RBWH Post Office, Herston QLD 4029 Australia
Country [2] 286721 0
Australia
Secondary sponsor category [3] 286936 0
University
Name [3] 286936 0
Australian Catholic University
Address [3] 286936 0
1100 Nudgee Road, Banyo, QLD 4014
Country [3] 286936 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289420 0
Metro South Health Service District Human Research Ethics Committee
Ethics committee address [1] 289420 0
Ethics committee country [1] 289420 0
Australia
Date submitted for ethics approval [1] 289420 0
14/08/2013
Approval date [1] 289420 0
12/09/2013
Ethics approval number [1] 289420 0
HREC/13/QPAH/497

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

Contacts
Principal investigator
Name 40378 0
Dr Zephanie tyack
Address 40378 0
Level 3, School of Allied and Public Health, Australian Catholic University, 1100 Nudgee Road, Banyo, QLD 4014.
Country 40378 0
Australia
Phone 40378 0
+61 427462286
Fax 40378 0
Email 40378 0
[email protected]
Contact person for public queries
Name 40379 0
Zephanie Tyack
Address 40379 0
Level 3, School of Allied and Public Health, Australian Catholic University, 1100 Nudgee Road, Banyo, QLD 4014.
Country 40379 0
Australia
Phone 40379 0
+61 427462286
Fax 40379 0
Email 40379 0
[email protected]
Contact person for scientific queries
Name 40380 0
Zephanie Tyack
Address 40380 0
Level 3, School of Allied and Public Health, Australian Catholic University, 1100 Nudgee Road, Banyo, QLD 4014.
Country 40380 0
Australia
Phone 40380 0
+61 427462286
Fax 40380 0
Email 40380 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.