Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000234415
Ethics application status
Approved
Date submitted
11/04/2007
Date registered
3/05/2007
Date last updated
3/05/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
IMPROVING SELF-MANAGEMENT IN ADOLESCENTS AND ADULTS WITH CYSTIC FIBROSIS.
Scientific title
The use of mentoring to improve self-efficacy and management in adolescents and adults with Cystic Fibrosis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 1769 0
Adolescence and the transition period 1770 0
Self-efficacy 1771 0
Condition category
Condition code
Human Genetics and Inherited Disorders 1857 1857 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Group 1.
Programme of mentoring alone. Weekly contact initially and then determined by participants preference. Goal-setting, motivational interviewing, role modelling are the tools to improve self-efficacy.

Intervention Group 2.
Programme of mentoring as Intervention arm 1, but with an IT tool to allow self-monitoring. The IT tool will either be a modified mobile phone or a desk top computer. Participants record their breathlessness, cough, sputum volume, general well-being on the phone and relate these symptoms to when they are well. A 0-10 visual analogue scale is used. They are also texted a rolling series of questions once a week to assess adherence with medication and airway clearance techniques.

The intervention arms go for six months and there is a six month washout period and self-efficacy is then re-assessed by questionnaire.
Intervention code [1] 1695 0
Behaviour
Comparator / control treatment
Control Arm 3. Usual care.
Control group
Active

Outcomes
Primary outcome [1] 2624 0
Improved self-efficacy is the primary outcome.
Timepoint [1] 2624 0
Assessed at baseline, three and six months and then again at one year (when the active arms have been discontinued for six months)
Primary outcome [2] 2625 0
1. Self-efficacy assessment using the Stanford Self-Efficacy for Managing Chronic Disease 6-Item Scale.
Timepoint [2] 2625 0
Primary outcome [3] 2626 0
2. CF-Related QoL questionnaire
Timepoint [3] 2626 0
Primary outcome [4] 2627 0
3. Symptom scores daily (as above)
Timepoint [4] 2627 0
Primary outcome [5] 2628 0
4. Assessment of patient, mentor and IT interactions; through monitoring of the mentor log book and IT data base (reviewed at completion of study)
Timepoint [5] 2628 0
Primary outcome [6] 2629 0
5. Process evaluation: focus groups (mentors)
Timepoint [6] 2629 0
Primary outcome [7] 2630 0
6. ITS use: acceptance, contribution to self-management interview
Timepoint [7] 2630 0
Secondary outcome [1] 4475 0
Improved quality of life
Timepoint [1] 4475 0
These symptoms will be recorded throughout the six month study period in the intervention arms. Lung function and clinical outcomes such as excaerbations will be assessed at baseline, three months, six months and 12 months in all study participants.
Secondary outcome [2] 4476 0
CF Related QoL questionnaire
Timepoint [2] 4476 0
These symptoms will be recorded throughout the six month study period in the intervention arms. Lung function and clinical outcomes such as excaerbations will be assessed at baseline, three months, six months and 12 months in all study participants.
Secondary outcome [3] 4477 0
Reduction in symptoms; breathlessness, cough, sputum volume, sputum colour.
Timepoint [3] 4477 0
These symptoms will be recorded throughout the six month study period in the intervention arms. Lung function and clinical outcomes such as excaerbations will be assessed at baseline, three months, six months and 12 months in all study participants.
Secondary outcome [4] 4478 0
General well-being.
Timepoint [4] 4478 0
These symptoms will be recorded throughout the six month study period in the intervention arms. Lung function and clinical outcomes such as excaerbations will be assessed at baseline, three months, six months and 12 months in all study participants.

Eligibility
Key inclusion criteria
Confirmed diagnosis of Cystic Fibrosis (CF). Clinical stability for two weeks as assessed by physician.
Minimum age
12 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe lung disease or associated co-morbidities such as cirrhosis and bleeding varices.Inability to comply with instructionsRecruitment should not occur during an acute exacerbation.

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)
Patients (and their parents) will be sent an invitation to participate in the study by mail. The invitation contains an outline of the study but no specific details. To register willingness to participate, the patient and parent will return a signed form expressing their desire to continue. Potential participants will then be approached during CF clinics at either the Gold Coast Hospital or Royal Children's in Brisbane and the study discussed in greater detail. Following written informed consent, participants will be randomised to usual care, a mentor alone or a mentor plus IT tool. This will be undertaken using a computer generated random number programme. Concealment of randomisation will be achieved by doing this electronically on a web site that is not accessible by the individual confirming suitability. Randomisation will be undertaken in Hobart on a secure server. The research assistants will be blinded to the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation will be undertaken by a computer generated random number software programme. Using stratified randomisation, we will ensure that an equal distribution of participants depending on whether they are recruited from an outreach clinic or a large central CF Centre clinic occurs and also that there will be an equal gender distribution.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The research assistants administer the questionnaires, but they are not involved in the mentoring process or clinical care of patients. The research assistants will be unaware of treatment allocation of the patients at the commencement of the study, but at follow up meetings for repeat questioonaires, it will become impossible to maintain blinding during the interview with participants.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2006 0
Charities/Societies/Foundations
Name [1] 2006 0
Australian Cystic Fibrosis Research Trust
Country [1] 2006 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian Cystic Fibrosis Research Trust
Address
Country
Australia
Secondary sponsor category [1] 1817 0
None
Name [1] 1817 0
N/A
Address [1] 1817 0
Country [1] 1817 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3726 0
Royal Hobart Hospital Ethics Committee
Ethics committee address [1] 3726 0
Ethics committee country [1] 3726 0
Australia
Date submitted for ethics approval [1] 3726 0
Approval date [1] 3726 0
28/09/2006
Ethics approval number [1] 3726 0
H0008939
Ethics committee name [2] 3727 0
Gold Coast Hospital Ethics Committee
Ethics committee address [2] 3727 0
Ethics committee country [2] 3727 0
Australia
Date submitted for ethics approval [2] 3727 0
Approval date [2] 3727 0
Ethics approval number [2] 3727 0
Ethics committee name [3] 3728 0
Royal Childrens Hospital Ethics Committee
Ethics committee address [3] 3728 0
Ethics committee country [3] 3728 0
Australia
Date submitted for ethics approval [3] 3728 0
Approval date [3] 3728 0
Ethics approval number [3] 3728 0

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

Contacts
Principal investigator
Name 27798 0
Address 27798 0
Country 27798 0
Phone 27798 0
Fax 27798 0
Email 27798 0
Contact person for public queries
Name 10884 0
Dr David Reid
Address 10884 0
Medical School
University of Tasmania
Collins Street
Hobart TAS 7001
Country 10884 0
Australia
Phone 10884 0
+61 3 62227043
Fax 10884 0
+61 3 62264894
Email 10884 0
[email protected]
Contact person for scientific queries
Name 1812 0
Dr David W Reid
Address 1812 0
Medical School
University of Tasmania
Collins Street
Hobart TAS 7001
Country 1812 0
Australia
Phone 1812 0
+61 3 62227043
Fax 1812 0
+61 3 62264894
Email 1812 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.