Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001150235
Ethics application status
Approved
Date submitted
3/07/2018
Date registered
12/07/2018
Date last updated
11/06/2019
Date data sharing statement initially provided
11/06/2019
Date results information initially provided
11/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of incentives on treatment rates among young people with rheumatic fever in Waikato, New Zealand
Scientific title
The effects of incentivizing young people with rheumatic fever through a mobile phone and monthly top-ups on secondary prophylaxis adherence
Secondary ID [1] 295378 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatic fever 308611 0
Condition category
Condition code
Cardiovascular 307562 307562 0 0
Other cardiovascular diseases
Inflammatory and Immune System 307643 307643 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Type of intervention: Receipt of mobile phone and monthly top-ups (money provided for data, phone calls, and texts).

Description: Data was collected by district nurses for a 3-month period prior to the start of the intervention (baseline) and then continued for 12 months post-intervention. Each injection period, nurses logged the frequency of calls/texts and visits along with date of injection scheduled and received. At the start of the intervention, district nurses provided the mobile phone.

During the study patients made appointments and received monthly injections as usual (i.e., there was no change for patients other than receiving the incentive). This included contacting their district nurse to arrange appointment time and location to administer injection. When patients didn't arrange a visit, nurses contacted patients via text or call to arrange a visit; this was also usual and customary practice. Nurses provided the monthly top-up when the injection was received. The top up was worth $20 and was directly provided by the nurse via an activation code. The top-ups were provided for 14 months (including two-months post final data collection). The phone was unlocked and given to the patients at the conclusion of the data collection.
Intervention code [1] 301699 0
Other interventions
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306539 0
Injection--whether it was received or not; Recorded by a district nurse shortly after the scheduled injection date (target: within one week). This information was reported onto a data collection form for this study and entered into the patients medical records.
Timepoint [1] 306539 0
Measured every 28 days for 15 months
Secondary outcome [1] 348809 0
Number of in-person visits by a district nurse to the patient; Recorded by a district nurse shortly after the scheduled injection date. (target: within one week). This information was reported onto a data collection form for this study.
Timepoint [1] 348809 0
Measured every 28 days for 15 months
Secondary outcome [2] 348810 0
Number of texts and phone calls made by district nurse to patient; Recorded by a district nurse shortly after the scheduled injection date (target: within one week). Texts and calls was a composite outcome. This information was reported onto a data collection form for this study.
Timepoint [2] 348810 0
Measured every 28 days for 15 months
Secondary outcome [3] 348811 0
Number of wasted injections; Recorded by a district nurse shortly after the scheduled injection date (target: within one week). A wasted injection occurred when a nurse took medicine to an appointment and the patient was unavailable and thus medicine had to be disposed. This information was reported onto a data collection form for this study.
Timepoint [3] 348811 0
Measured every 28 days for 15 months
Secondary outcome [4] 348812 0
District Nurse Satisfaction--self- rated on a single item scale from 1-10 (dissatisfied to satisfied); Item created for this study. Provided by the district nurse shortly after the scheduled injection date (target: within one week).
Timepoint [4] 348812 0
Measured every 28 days for 15 months
Secondary outcome [5] 349058 0
Cost-effectiveness. To address cost effectiveness, a decision tree was built for the incentives in increasing the adherence of penicillin injections. The cost-effectiveness analysis was from the perspective of public provider. Only direct costs to providers were included, and costs to patients were not considered. The direct costs to providers included costs of visit before injection, penicillin injection, materials for injection, transport, nurses’ time, phones, top ups and phone calls from the nurses. The unit costs were provided by the provider and government data. Incremental analysis was performed in terms of incremental cost-effectiveness ratio by dividing the incremental costs with the incremental injections by applying the intervention. The main cost effectiveness outcome was cost per extra successful injection.
Timepoint [5] 349058 0
Overall project.

Eligibility
Key inclusion criteria
Registered patient on the Waikato District Health Board 's registry for patients with rheumatic fever
Minimum age
14 Years
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None other than age

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
All patients on the registry within the age range were eligible for inclusion. Patients were monitored for 3 months prior to intervention to establish a baseline of behaviour. The intervention was provided and then measured for an additional 12 months.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size included 85 patients. Expected enrollment was 75 (approx 10% refusal rate). The size is sufficient (p=.05; power=.80) to identify an increase in injections from the baseline period . This is sufficient for this small-scale study and will help to identify effect sizes for a larger-scale study if the intervention has efficacy.

Data analysis included the following: a) repeated measures analysis of variance for each of the dependent variables with two key independent variables: 1) time (five measures of baseline, quarter 1, quarter 2, quarter 3, quarter 4; and 2) patient status at baseline (current/adherent or intermittent/non-adherent); b) incremental cost-effectiveness ratio (ICER) calculated for each additional injection; and c) thematic analysis of open-ended interview questions with a subsample of patients and district nurses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/08/2016
Date of last participant enrolment
Anticipated
Actual
31/08/2016
Date of last data collection
Anticipated
Actual
31/10/2017
Sample size
Target
85
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 10601 0
New Zealand
State/province [1] 10601 0
Waikato

Funding & Sponsors
Funding source category [1] 299968 0
Charities/Societies/Foundations
Name [1] 299968 0
Waikato Medical Research Foundation
Country [1] 299968 0
New Zealand
Funding source category [2] 299973 0
University
Name [2] 299973 0
University of Waikato
Country [2] 299973 0
New Zealand
Funding source category [3] 299974 0
Commercial sector/Industry
Name [3] 299974 0
Spark Foundation
Country [3] 299974 0
New Zealand
Primary sponsor type
Individual
Name
John Oetzel
Address
University of Waikato
Private Bag 3105
Hamilton 3240
Country
New Zealand
Secondary sponsor category [1] 299348 0
Individual
Name [1] 299348 0
Michelle Morley
Address [1] 299348 0
Waikato District Health Board--Population Health
Level 5, Hugh Monckton Trust Building
Cnr Harwood and Rostrevor Streets
Hamilton 3204
Country [1] 299348 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300830 0
Northern A Health and Disability Ethics Committee.
Ethics committee address [1] 300830 0
Health and Disability Ethics Committees
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 300830 0
New Zealand
Date submitted for ethics approval [1] 300830 0
01/04/2016
Approval date [1] 300830 0
12/08/2016
Ethics approval number [1] 300830 0
16/NTA/33

Summary
Brief summary
Youth who have had Rheumatic Fever (RF) need monthly penicillin injections to prevent Rheumatic Heart Diseases (RHD). About 20 % of 14- 21 year olds on the Waikato RF registry are non-compliant; past efforts to increase compliance have been unsuccessful. This study uses a multiple baseline research design to provide a test of an incentivized intervention (specifically mobile phone with monthly top-ups for data, text and calling) for increased compliance, especially for youth who are intermittent with their injections or have stopped receiving them. The outcome of this study will include measures of the efficacy and cost effectiveness in terms of number of increased injections and incremental cost for each extra injection.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84954 0
Prof John Oetzel
Address 84954 0
University of Waikato
Private Bag 3105
Hamilton 3240
Country 84954 0
New Zealand
Phone 84954 0
+6478384431
Fax 84954 0
Email 84954 0
john.oetzel@waikato.ac.nz
Contact person for public queries
Name 84955 0
Prof John Oetzel
Address 84955 0
University of Waikato
Private Bag 3105
Hamilton 3240
Country 84955 0
New Zealand
Phone 84955 0
+6478384431
Fax 84955 0
Email 84955 0
john.oetzel@waikato.ac.nz
Contact person for scientific queries
Name 84956 0
Prof John Oetzel
Address 84956 0
University of Waikato
Private Bag 3105
Hamilton 3240
Country 84956 0
New Zealand
Phone 84956 0
+6478384431
Fax 84956 0
Email 84956 0
john.oetzel@waikato.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We didn't request sharing of data with participants during the informed consent process.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.