Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000614392
Ethics application status
Approved
Date submitted
21/04/2017
Date registered
28/04/2017
Date last updated
28/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Whakapai e Te Ara Ha: Asthma Self-Management Programme for the whanau of tamariki Maori with Asthma
Scientific title
Whakapai e Te Ara Ha: Asthma Self-Management Programme. A single-blinded, parallel group, randomised controlled trial of the impact of a culturally-relevant peer-support and self-management programme, on activation and quality of life among the parents/caregivers of Maori children aged 4-13 years old with asthma in New Zealand, and asthma control, quality of life and health-care utilisation among their children.
Secondary ID [1] 289734 0
Nil Known
Universal Trial Number (UTN)
U1111-1183-1961
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 299578 0
Wheeze
 299579 0
Condition category
Condition code
Respiratory 299546 299546 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive a six-month holistic, culturally-based peer-support programme. The intervention will comprise two phases: an initial 6-week intensive 'whakawhanaungatanga’ (relationship building) period and an ‘awhi’ (support) maintenance period over the remainder of the 6 months.

The 6-week initial intervention is an approved research derivative of the Stanford Chronic Disease Self-Management Program (CDSMP), it has been customised for our particular requirements (i.e. for the parent/caregiver of a child with asthma and culturally appropriate for Maori). The programme consists of six 2-2.5 hour community-based, peer-led patient self-management education workshops which take place weekly over six weeks. Sessions include general topics about chronic disease management: e.g. exercise; use of cognitive symptom management techniques; nutrition; fatigue and sleep management; use of community resources; use of medications; dealing with emotions (anxiety, depression etc.); communication with health professionals; problem-solving; and decision-making.

The informational materials and training requirements for the CDSMP programme are available here: http://patienteducation.stanford.edu/programs/cdsmp.html. The CDSMP derivative incorporates materials approved for use within a New Zealand context, specifically the Diabetes and Healthy Food Choices guide, published by Diabetes New Zealand, and all materials incorporate the use of Te Reo Maori. The Children and Asthma booklet published by the Asthma and Respiratory Foundation of New Zealand will be provided to all participants (both cases and controls) as it outlines relevant disease specific information.

The workshops will be led by Stanford approved peer-leaders who have been specifically trained in the research derivative of the CDSMP programme. Peer leaders (a combination of research staff and lay community members) all have lived-experience of long-term condition management with asthma. Programme fidelity is ensured by direct oversight of all peer leaders and workshops by two CDSMP Master Trainers in accordance with usual Stanford CDSMP programme fidelity requirements.

After the initial phase, research staff will maintain fortnightly telephone contact to check-in with whanau (families) (the ‘awhi’ phase) to provide as-needed support with referrals, healthcare navigation, additional skill development.

Participants in this group are able to access care from their GP as usual. This culturally-based approach differs from mainstream ‘intensive’ asthma management programmes in that it is Te Ao Maori (Maori worldview)-centred.
Intervention code [1] 295371 0
Behaviour
Intervention code [2] 296028 0
Lifestyle
Intervention code [3] 297900 0
Treatment: Other
Comparator / control treatment
Usual Care. Participants in the control group will receive appropriate educational resources (Children and Asthma Booklet) from the Asthma Foundation of NZ and be followed-up by their usual GP without limitation. All control group participants will be offered referral to a Maori health provider (or Asthma Society) of their preference at the end of the trial (i.e. 12-months following baseline). No restriction is placed on participation in other usual care pathways or disease-specific education.
Control group
Active

Outcomes
Primary outcome [1] 299026 0
Parent or caregiver activation, as measured by parent or caregiver Patient Activation Measure (PAM), a validated scale of activation. This will be completed by the parent or caregiver.
Timepoint [1] 299026 0
To be completed at baseline, 3 months, 6 months and 12 months.
Primary outcome [2] 299027 0
Asthma Control, as measured by the Child Asthma Control Test (C-ACT). This will be completed by the child and the parent or caregiver.
Timepoint [2] 299027 0
Completed at baseline, 3 months, 6 months and 12 months
Primary outcome [3] 299028 0
Healthcare Utilisation, expressed as the number of ED presentations or hospital admissions for asthma or wheeze over the previous 12 months, by interviewer administered questionnaire. The questionnaire was designed specifically for this study but derived in large part from the New Zealand Health Survey (Child Questionnaire) .
Timepoint [3] 299028 0
Measured at baseline and 12 months.
Secondary outcome [1] 325892 0
Parents/Caregivers Quality of Life:
Assessed via the Paediatric Asthma Caregiver Quality of Life Questionnaire (PACQLQ) and the EuroQol EQ-5D-Y (Proxy 1 Version)

Timepoint [1] 325892 0
This will be measured at baseline, 3 months, 6 months and 12 months
Secondary outcome [2] 325893 0
Child Quality of Life:
Assessed via the Paediatric Asthma Quality of Life Questionnaire (PAQLQ) and EuroQol EQ-5D-Y
Timepoint [2] 325893 0
This will be measured at baseline, 3 months, 6 months and 12 months
Secondary outcome [3] 325894 0
Healthcare Utilisation - Afterhours/Urgent GP visits
This data will be collected by interviewer-administered questionnaires from participants.
The questionnaire was designed specifically for this study but derived in large part from the New Zealand Health Survey (Child Questionnaire) .
Timepoint [3] 325894 0
Measured at baseline, 3 months, 6 months and 12 months
Secondary outcome [4] 325895 0
Economic Impact (Cost effectiveness & Cost-utility)
Data collection for this outcome will include the detailed healthcare utilisation (as above), but additionally an assessment of direct medical costs (GP visits, prescriptions etc.) and indirect costs such as loss of productivity (e.g. days missed from school due to asthma, caregiver days missed from work due to asthma). Again, for the purposes of standardisation, these data will be obtained by interviewer-administered questionnaire using questions based on the New Zealand Health Survey.
The most appropriate economic evaluation method, given the data availability, is a cost effectiveness analysis in which the change in costs and health effects between those at baseline and study end are compared. In addition, however, we also aim to collect robust quality of life data, which will permit a cost utility study using the EQ5D-Y with New Zealand weights applied.
Timepoint [4] 325895 0
Measured at baseline, 3 months, 6 months and 12 months. Reported at baseline vs 12 months.
Secondary outcome [5] 334228 0
Qualitative Assessment (Acceptability & Effectiveness)
A Phenomenological Approach will be used to analyse participant experiences. Semi-structured interviews will be undertaken with a purposive sub-group of participants at the end of the intervention. Interviews will capture whanau experiences of the intervention, aspects that were successful, and areas requiring refinements or adaptations. Interviews will be recorded, transcribed verbatim, then organised and coded within NVivo (Trademark) software.
Timepoint [5] 334228 0
This will be measured at completion of the intervention (6 months).

Eligibility
Key inclusion criteria
Parents/caregivers of children will be recruited prospectively through the Paediatric wards, Child Assessment Units, and Emergency Departments of participating District Health Boards (PROSPECTIVE). Additionally, invitations from eligible children with historic admissions/presentations to hospital or emergency departments from the same participating DHBs will supplement recruitment in batched reverse sequential order (RETROSPECTIVE).

Parents/caregivers will be eligible to participate if their child is:
a) between 4-13 years,
b) identifies as NZ Maori ethnicity (prioritised, self/parental reported),
c) has a doctor diagnosis of asthma,
d) has a previous hospitalisation or Emergency Department presentation for asthma or wheeze (ICD-10-AM code: J45,J46 or R06.2), and
e) usually resides within the geographical catchment area of the participating DHB’s (District Health Boards).
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents/caregivers will be excluded from participating if their child:
a) has previously been enrolled in the study;
b) has a sibling on the study;
c) does not reasonably expect to remain in the region for the duration of the intervention and follow-up or
d) have other chronic respiratory comorbidities that may be deemed to interfere with the study (e.g. bronchiectasis).

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)
Allocation concealed- central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Up to 315 participants will be recruited from participating district health boards. Allowing for a drop-out rate of 10% means this will provide 143 participants per group (treatment and control) for analysis.

There are three primary outcomes for this study. Patient Activation, as measured by the PAM after the participants have completed the workshop (primarily evaluated at 12 weeks post baseline); the childhood asthma control test (C-ACT), (primarily evaluated at six months after baseline); and number of hospitalizations (admissions or ED presentations) per year, (primarily evaluated at one year post baseline).

143 participants per group will provide 80% power to detect, at the 0.05 level, an effect size d of 0.5, or a difference in mean PAM scores of 66 to 73 (G*Power 3.1.9.2). This size of difference was seen in Morrison et al (REF: Morrison D, Wyke S, Saunderson K, McConnachie A, Agur K, Chaudhuri R, Thomas M, Thomson NC, Yardley L, Mair FS, “Findings from a pilot randomised trial of an asthma internet self-management intervention (RAISIN),” BMJ Open, 2016; 6: e009254. DIO: 10.1136/bmjopen-2015-009254).

143 participants per group will provide 80% power to detect, at the 0.05 level, a difference in mean C-ACT of 20 to 22 between the two groups (G*Power 3.1.9.2). this is the same size of difference found by Piacentini et al (REF: Piacentini GL, Peroni DG, Bodini A, Bonafiglia E, Rigotti E, Baraldi E, Liu AH, and Boner AL, “Childhood asthma control test and airway inflammation evaluation in asthmatic children,” Allergy 2009; 64:1753-1757).

143 participants per group will provide 80% power to detect at the 0.05 level, a difference in admission/ ED presentation rates between 0.96 and 0.55, the difference observed by Greineder et al (REF: Greineder DK, Loane KC, Parks P, “A randomized controlled trial of a 23 pediatric outreach program,” J Allergy Clin Immunol, March 1999, pp 436-440).
(https://www.statstodo.com/SSiz2Counts_Tab.php).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2017
Actual
Date of last participant enrolment
Anticipated
30/11/2017
Actual
Date of last data collection
Anticipated
30/11/2018
Actual
Sample size
Target
315
Accrual to date
Final
Recruitment outside Australia
Country [1] 8047 0
New Zealand
State/province [1] 8047 0

Funding & Sponsors
Funding source category [1] 294120 0
Government body
Name [1] 294120 0
Health Research Council of New Zealand
Country [1] 294120 0
New Zealand
Primary sponsor type
University
Name
University of Otago- Wellington
Address
23a Mein Street
Newtown
Wellington
New Zealand
6021
Country
New Zealand
Secondary sponsor category [1] 292948 0
None
Name [1] 292948 0
None
Address [1] 292948 0
None
Country [1] 292948 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295526 0
Health and Disability Ethics Committees
Ethics committee address [1] 295526 0
Ethics committee country [1] 295526 0
New Zealand
Date submitted for ethics approval [1] 295526 0
25/05/2016
Approval date [1] 295526 0
03/08/2016
Ethics approval number [1] 295526 0
16/NTB/95

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

Contacts
Principal investigator
Name 67622 0
Dr Tristram Ingham
Address 67622 0
University of Otago Wellington
23a Mein Street
Newtown
Wellington
New Zealand 6022

PO Box 7343
Wellington South
New Zealand
Country 67622 0
New Zealand
Phone 67622 0
+6449186842
Fax 67622 0
Email 67622 0
[email protected]
Contact person for public queries
Name 67623 0
Daniel Aldridge
Address 67623 0
University of Otago Wellington
23a Mein Street
Newtown
Wellington
New Zealand 6022

PO Box 7343
Wellington South
New Zealand
Country 67623 0
New Zealand
Phone 67623 0
+6449186041
Fax 67623 0
Email 67623 0
[email protected]
Contact person for scientific queries
Name 67624 0
Tristram Ingham
Address 67624 0
University of Otago Wellington
23a Mein Street
Newtown
Wellington
New Zealand 6022

PO Box 7343
Wellington South
New Zealand
Country 67624 0
New Zealand
Phone 67624 0
+6449186842
Fax 67624 0
Email 67624 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
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