Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000743268
Ethics application status
Approved
Date submitted
26/04/2018
Date registered
3/05/2018
Date last updated
3/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A novel model of care for Maori with chronic airways disease
Scientific title
A pilot study of a novel model of care for Maori with chronic airways disease to improve engagement, knowledge and understanding of chronic airways disease and self-management and sense of control over disease.
Secondary ID [1] 294737 0
None
Universal Trial Number (UTN)
U1111-1209-1814
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic airways disease 307610 0
Condition category
Condition code
Respiratory 306664 306664 0 0
Other respiratory disorders / diseases
Respiratory 306665 306665 0 0
Chronic obstructive pulmonary disease
Respiratory 306666 306666 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Non-randomised, non controlled, pre-post pilot study.
The intervention involves four steps.

1. Development of critical consciousness by the research team. Informational materials relating to health inequities, privilege, racism and patient centred care will be used for training the research team (this step will be undertaken prior to the step 2).
a. The training of the research team will be self-directed and includes on a variety of written and audiovisual resources (appendix 14) that have been selected through the Principal Investigator's PhD studies. These informational materials have not been designed specifically for this study, and are available online.
b. Although there are no specific strategies to ensure adherence to the training, the research team will spend 1-2 hours discussing the resources and their application to the clinical setting and current research study. This will ensure both members of the research team have a mutual understanding about the concept of critical consciousness and its clinical application. The expected duration of training is 10-20 hours. The research team consists of a respiratory physician (Principal Investigator) and research nurse.

2. Establishment of a 'connection' with participants to enable engagement. x1 face-to-face, person/whanau (family) focussed session involving the research team (respiratory physician and nurse) and participant/whanau (family). This session will provide an opportunity for the research team to begin to establish a therapeutic alliance with the participant/whanau and build a picture of the participant in their multidimensional context with the goal of optimising self management of chronic airways disease . No physical or informational materials will be used. Questionnaires will be completed during this session. The expected duration of this step is 60-90 minutes and will be undertaken in week 1.

3. Education session(s).
a. Two or more face-to-face, person/whanau (family) focussed sessions involving the research team (respiratory physician and nurse) and participant/whanau (family), with the delivery of education relating to self-management of chronic airways disease.
b. Education sessions will be provided until the research team are satisfied that the participant/whanau have an adequate knowledge and understanding of self management of chronic airways disease (the expected number of sessions is two, but may be up to four).
c. Informational materials will include basic disease-specific information e.g. cause, symptoms, treatment, prognosis and action plans will be used. Resources will be from The Asthma and Respiratory Foundation www.asthmafoundation.org.nz, www.bronchiectasis.com.au and healthliteracy.co.nz. The expected duration of this step is 1-4 hours and will be undertaken in Weeks 2-3).
d. A questionnaire (appendix 3) relating to knowledge and skills of chronic airways disease and self management will be completed by the research team prior to and following this session. This questionnaire has been designed specifically for this study and has not been validated.
e. Records will be kept on session attendance. Participants will receive phone call reminders of future sessions to facilitate attendance.

4. Self management support sessions.
a. These sessions will be undertaken over the phone (or face-to-face if required).
b. The expected number of sessions is between 1 and 4. The number of sessions will be determined by the progress of the participant e.g. if the participant is struggling with self management, they may require more frequent support. The participant will have the contact details of the research staff within working hours, and will be provided with contact details of an after hours advice line (Healthline 0800 611 116) and emergency services (111).
c. The duration of this step is expected to be between 1 - 4 hours. The duration of the phone sessions are expected to be between 5-30 minutes but may last for up to 60 minutes.
d. Topics which may be covered include information about chronic airways disease and its treatment options, the self management plan, issues arising relating to health related behaviours e.g smoking cessation, medication side effects, exercise programme, issues relating to monitoring and managing symptoms and signs of chronic airways disease or other comorbidities, social issues. Where appropriate, referrals will be made to other services, e.g. social worker, psychologist, physiotherapist.
e. These sessions will be undertaken in weeks 4-6.

Questionnaires will be administered following this step in a wrap up session which will be in week 6.
Intervention code [1] 301022 0
Lifestyle
Intervention code [2] 301023 0
Behaviour
Intervention code [3] 301024 0
Treatment: Other
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305673 0
Engagement will be measured with
1. number of sessions attended or not attended (quantitative)
Timepoint [1] 305673 0
Baseline and 6 weeks post baseline
Primary outcome [2] 305674 0
Knowledge and understanding of chronic airways disease and self-management (composite primary outcome)
This will be measured using an instrument that we designed for this study which has not been validated in any previous studies (appendix 3 attachment)
Timepoint [2] 305674 0
Baseline (week 2), at completion of the education sessions (week 3 or 4, depending on the time taken for education to be deemed adequate by the research team) and 6 weeks post baseline
Primary outcome [3] 305675 0
Sense of control over disease
This will be measured using an instrument that we designed for this study which is not validated in any previous studies (appendix 12 attachment)
Timepoint [3] 305675 0
Baseline and 6 weeks post baseline
Secondary outcome [1] 346130 0
1. Prescription uptake from pharmacy records
Timepoint [1] 346130 0
Baseline and 6 weeks post-baseline
Secondary outcome [2] 346131 0
CAD exacerbation rate (use of antibiotics and
prednisone) as assessed by the research team by reviewing medical and pharmacy records.
Timepoint [2] 346131 0
At baseline, 6 months and 12 months post completion
Secondary outcome [3] 346132 0
Quality of life will be assessed using the COPD Assessment Test (CAT), validated in Gupta, N., Pinto, L. M., Morogan, A., & Bourbeau, J. (2014). The COPD assessment test: a systematic review. Eur Respir J . 44: 873-884
Timepoint [3] 346132 0
Baseline, and 6 weeks post-baseline
Secondary outcome [4] 346178 0
Psychological distress will be assessed using the Hospital Anxiety and Depression Scale (HADS), validated in Bjelland, I. et al (2002). The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 52(2):69-77.
Timepoint [4] 346178 0
At baseline and 6 weeks post baseline
Secondary outcome [5] 346237 0
Engagement of Maori patients/whanau in a culturally safe manner will be assessed using the Participant Reported Experience questionnaire (primary outcome) as assessed by the research team. This questionnaire has been designed by the research team and not yet validated. (appendix 6)
Timepoint [5] 346237 0
6 weeks post baseline
Secondary outcome [6] 346238 0
Smoking status (current, ex, never) as determined by self report and quantified in terms of pack years (number of packs/day multiplied by number of years)
Timepoint [6] 346238 0
At baseline and 6 weeks post baseline
Secondary outcome [7] 346239 0
Nutrition status (weight) measured in kg using a digital scale.
Timepoint [7] 346239 0
Baseline and 6 weeks post baseline
Secondary outcome [8] 346240 0
Daily minutes of exercise as assessed by self report
Timepoint [8] 346240 0
Baseline and 6 weeks post baseline
Secondary outcome [9] 346241 0
Outpatient clinic attendance/non-attendance as assessed by the study team using medical records.
Timepoint [9] 346241 0
At baseline, 6 months and 12 months post completion
Secondary outcome [10] 346242 0
Pulmonary rehabilitation attendance/non-attendance as assessed by the study team using medical records.
Timepoint [10] 346242 0
At baseline, 6 months and 12 months post completion
Secondary outcome [11] 346243 0
Hospitalisation rate (CAD related) as assessed by the study team using medical records.
Timepoint [11] 346243 0
At baseline, 6 months and 12 months post completion
Secondary outcome [12] 346244 0
Quality of life will be measured using the Hua Ora, validated in McClintock KK, Mellsop GW, Kingi TK. Development of a culturally attuned psychiatric outcome measure for an indigenous population. International Journal of Culture and Mental Health DOI:10.1080/17542863.2010.537484.'
Timepoint [12] 346244 0
Baseline and 6 weeks post baseline
Secondary outcome [13] 346245 0
Psychological distress will be assessed using the Kessler-6, validated in Kessler,R.C., Andrews, G., Colpe, L J.,Hiripi, E., Mroczek, D.K., Normand, S.-L.T., Walters, E.E., & Zaslavsky, A. (2002) Short screening scales to monitor population prevalence’s and trends in nonspecific psychological distress. Psychological Medicine.32(6),959-976
Timepoint [13] 346245 0
Baseline and 6 weeks post-baseline
Secondary outcome [14] 346331 0
Feasibility will be assessed as a composite of:
a) Recruitment rates as determined by study records
b) Consent rates as determined by study records
c) Adequacy of eligibility criteria as described by the research team e.g. too inclusive or exclusive.
d) Retention rates assessed using attendance checklists,
e) Completion rates as determined by study records
f) Acceptability of questionnaires as determined by participants in the Acceptability Questionnaire (appendix 13)
g) Acceptability of critical consciousness resources as described by the study team.
h) Acceptability of the duration and location of the session(s) as described by the research team..
Timepoint [14] 346331 0
6 weeks post baseline

Eligibility
Key inclusion criteria
1. Signed written informed consent to participate
2. Chronic airways disease, including chronic obstructive airways disease (COPD), chronic asthma and bronchiectasis, as defined by
a. GINA 2014 (1)
b. GOLD 2009 (2)
c. TSANZ 2014 (3)
3. Self-identified ethnicity as Maori
4. Aged 16 years or older
5. Preferential recruitment of participants whose health needs are not met fully by mainstream health services
a. Previous history of disengagement with mainstream health services e.g. outpatient
clinic non-attendance
b. Low health literacy as previously identified by medical staff.

References
(1) Global Initiative For Asthma. Global Strategy for Asthma
Management and Prevention. Vancouver, WA, USA: GINA,2014 [May 2014]. www.ginasthma.org.)
(2)Global Initiative for Chronic Obstructive Lung Disease. Global strategy
for diagnosis, management and prevention of COPD.
(3)Chang AB, Bell SC, Byrnes CA, Grimwood , Holmes P, King PT, Kolbe J, Landau LI, Maguire G, McDonald M, Reid D, Thien F, Antic R, Torzillo PJ. Bronchiectasis and chronic suppurative lung disease in Australia and New Zealand - Thoracic Society of Australia and New Zealand (TSANZ) position statement. Medical Journal of Australia. 193(6):356-65, 2014.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide written informed consent to participate.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Pre and post-test comparative analysis will be performed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/05/2018
Actual
Date of last participant enrolment
Anticipated
29/05/2018
Actual
Date of last data collection
Anticipated
10/07/2018
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 10355 0
New Zealand
State/province [1] 10355 0

Funding & Sponsors
Funding source category [1] 299335 0
Hospital
Name [1] 299335 0
Auckland City Hospital
Country [1] 299335 0
New Zealand
Primary sponsor type
Hospital
Name
Auckland City Hospital
Address
2 Park Road
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 298605 0
None
Name [1] 298605 0
Address [1] 298605 0
Country [1] 298605 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300242 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 300242 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 300242 0
New Zealand
Date submitted for ethics approval [1] 300242 0
22/02/2018
Approval date [1] 300242 0
16/04/2018
Ethics approval number [1] 300242 0
18/NTB/34

Summary
Brief summary
Chronic airways disease includes chronic obstructive pulmonary disorder (COPD), bronchiectasis and asthma. Mâori with chronic airways disease fall through the ‘gaps’ in our current healthcare system, resulting in inequitable health outcomes. The ‘gaps’ represent a mal-alignment of western and Maori ways, which can be explained by racism and colonisation.
The goal of chronic disease management is to enable and support individuals/whanau to self-manage their disease in order to optimise health outcomes. The process begins with a with developing a therapeutic alliance, within which individuals/whanau are equipped with knowledge and support in order to self-manage.
Our qualitative research has identified key assumptions and expectations of the health system which have resulted in health services becoming out of reach for many Mâori: patients trust in the western system; patients hold western and biomedical worldviews; patients have the necessary physical, financial, emotional and educational resources to adopt health promoting behaviours.
We have designed an approach which involves changing health system structures and practices in order to meet the needs of patients/whanau. This small-scale pilot study aims to determine the feasibility and acceptability and the efficacy of the intervention which aims to
1/ Engage Maori patients/whanau with specialist respiratory services in a culturally safe manner
2/Improve participant/whanau knowledge about chronic airways disease and self-management of their condition and
3/ Help the patient to achieve a greater sense of control of their disease.
The study will also gain a signal of whether the intervention can influence the participants to adopt health promoting behaviours and improve other health outcomes.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2641 2641 0 0
/AnzctrAttachments/374991-Appendix 3 Knowledge and skills.docx (Supplementary information)
Attachments [2] 2642 2642 0 0
/AnzctrAttachments/374991-Appendix 12 SOC.docx (Supplementary information)
Attachments [3] 2643 2643 0 0
/AnzctrAttachments/374991-Appendix 6 PRE.docx (Supplementary information)
Attachments [4] 2657 2657 0 0
/AnzctrAttachments/374991-Appendix 13 Acceptability.docx (Supplementary information)
Attachments [5] 2658 2658 0 0
/AnzctrAttachments/374991-Appendix 14 Resources for Critical Consciousness.docx (Supplementary information)

Contacts
Principal investigator
Name 83022 0
Dr Sandra Hotu
Address 83022 0
Respiratory Services
2 Park Road
Grafton
Auckland 1023
Country 83022 0
New Zealand
Phone 83022 0
+64 21 705715
Fax 83022 0
+64 9 6310712
Email 83022 0
[email protected]
Contact person for public queries
Name 83023 0
Dr Sandra Hotu
Address 83023 0
Respiratory Services
2 Park Road
Grafton
Auckland 1023
Country 83023 0
New Zealand
Phone 83023 0
+64 21 705715
Fax 83023 0
+64 9 6310712
Email 83023 0
[email protected]
Contact person for scientific queries
Name 83024 0
Dr Sandra Hotu
Address 83024 0
Respiratory Services
2 Park Road
Grafton
Auckland 1023
Country 83024 0
New Zealand
Phone 83024 0
+64 21 705715
Fax 83024 0
+64 9 6310712
Email 83024 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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