Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000249358
Ethics application status
Approved
Date submitted
2/02/2017
Date registered
17/02/2017
Date last updated
23/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Wellbeing Intervention for Chronic Kidney Disease (WICKD): A Trial of the Aboriginal and Islander Mental Health Initiative (AIMhi) Stay Strong App.
Scientific title
Wellbeing Intervention for Chronic Kidney Disease (WICKD): A Trial of the Aboriginal and Islander Mental Health Initiative (AIMhi) Stay Strong App.
Secondary ID [1] 290171 0
None
Universal Trial Number (UTN)
U1111-1187-7047
Trial acronym
WICKD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological distress 300310 0
Chronic Kidney Disease 301899 0
Condition category
Condition code
Mental Health 300174 300174 0 0
Other mental health disorders
Renal and Urogenital 301568 301568 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1-Early Treatment with MCP using the AIMhi Stay Strong App

Participants who are randomised to the intervention complete a Motivational Care Plan (MCP) interview using the AIMhi Stay Strong App (on a tablet device) at baseline, with one further session using the App within two to four weeks. Session 1 explores family, current strengths and worries. Participants are encouraged to set 1-2 goals that are achievable, meaningful, and practical for addressing an identified worry.
The client-centered nature of the intervention ensures the goals are client driven and empowers them to take manageable steps toward achieving that goal. Session 2 reviews and refines the goals (identifies whether goals and steps were achieved) and helps clients address any barriers to goal attainment and set new goals as appropriate. Participants receive a text message or phone call following the initial treatment reminding them of their goals and steps for making change and a further text message or phone call at weeks 10-11 reminding them of the planned 3 month follow up assessments.

Participants in the early treatment group also receive a further two sessions using the AIMhi Stay Strong app following the 3 month follow up assessment. The two sessions also occur 2-4 weeks apart and follow a similar format to the sessions received at baseline – reviewing family, strengths, worries and previous goals set and sets new goals. Participants receive a text message or phone call following the initial treatment reminding them of their goals and steps for making change and further text message or phone call at weeks 21-22 reminding them of the planned 6 month follow up assessments. A text message or phone call is received between the two sessions to remind participants of their goals and the time for the next session. Participants in the early treatment group also receive usual care from their renal service provider.


Sessions using the app involve a supervised session during which the session is completed digitally on the app in a face to face session between participant and research officer/therapist. The app is designed to provide step by step instruction for the therapist and to be used by a range of practitioners with little professional training in counselling such as Indigenous wellbeing workers. The research officers delivering the treatment have varied undergraduate and post graduate qualifications. They have all received specific training in the use of the App and related basic counselling techniques.
The approximate duration of the treatment session is thirty minutes. The key reason for use of phone reminders rather than text reminders is that of facility with English language. For those with limited English language knowledge a text message is less likely to be an effective means of communication. Most Alice Springs based participants will receive phone calls rather than text messages. The pictorial summary provided is paper based and handed to the participant. It is an electronic summary of what has been entered into the app during the session: supportive family (name, role, relationship); strengths (e.g. work, exercise), stressors (eg physical illness, smoking) and change goals discussed (eg 'decrease smoking' and steps to that goal eg 'contact quit line'). The app software monitors timing of each session and whether each page has been addressed in each session. The researcher/therapist records comments after each session and notes any areas for discussion at regular fidelity review meetings (fortnightly).
Intervention code [1] 296587 0
Treatment: Other
Intervention code [2] 297078 0
Treatment: Devices
Comparator / control treatment
Arm 2 - Contact Control/Late Treatment - (CC/LT)

Participants who are randomised to CC/LT receive 20 minutes of contact with the researcher using a culturally appropriate generic health App (i.e. The Hep B Story) at baseline with a further session using the app after three to four weeks. Session 1 of CC goes through the structured Hep B App. Discussion specifically avoids review of family, strengths or individual goal setting. The participant interacts with the App with support from the researcher and discussion focuses on navigation of the App and the App content. A ‘goal’ is agreed to talk to someone else in their family about the app content before the next session. A pictorial summary (utilising similar colours and images to the intervention summary) is given to the client. Session 2 reviews the information discussed in Session 1. This ensures each group receives the same contact time with researchers and interaction based on a structured App to aid participant blinding and to structure the control session. Participants receive a text message or phone call with a health tip linked with the health App in the intervening weeks. Participants also receive a text message or phone call at weeks 10-11 to remind them of the planned 3 month follow up assessments.

Participants in the CC/LT group then receive a MCP interview using the AIMhi Stay Strong App (on a tablet device) following their 3 month follow up assessment, with one further session using the App within three to four weeks. Session 1 explores family, current strengths and worries. Participants are encouraged to set 1-2 goals that are achievable, meaningful, and practical for addressing an identified worry. The client-centered nature of the intervention ensures the goals are client driven and empowers them to take manageable steps toward achieving that goal. Session 2 reviews and refines the goals (identifies whether goals and steps were achieved) and helps clients address any barriers to goal attainment and set new goals as appropriate. Participants receive a text message or phone call reminding them of their goals and steps for making change in the intervening weeks. Participants also receive a text message or phone call at weeks 21-22 to remind them of the planned 6 month follow up assessments.

Participants in the CC/LT group also receive usual care from their renal service provider.

Arm 3 - Treatment as usual/Late treatment (TAU/LT)
Baseline: Participants who are randomised to TAU/LT receive no researcher intervention at baseline. Participants in this group receive only usual care from their renal service provider. Participants receive a text message or phone call at weeks 10-11 to remind them of the planned 3 month follow up assessments.

Participants in the TAU/LT group then receive a MCP interview using the AIMhi Stay Strong App (on a tablet device) following their 3 month follow up assessment, with one further session using the App within three to four weeks. Session 1 explores family, current strengths and worries. Participants are encouraged to set 1-2 goals that are achievable, meaningful, and practical for addressing an identified worry. The client-centered nature of the intervention ensures the goals are client driven and empowers them to take manageable steps toward achieving that goal. Session 2 reviews and refines the goals (identifies whether goals and steps were achieved) and helps clients address any barriers to goal attainment and set new goals as appropriate. Participants receive a text message or phone call reminding them of their goals and steps for making change in the intervening weeks. Participants also receive a text message or phone call at weeks 21-22 to remind them of the planned 6 month follow up assessments.

Participants in the TAU/LT group also receive usual care from their renal service provider.
Control group
Active

Outcomes
Primary outcome [1] 300468 0
Change in psychological distress as measured by the Kessler distress scale (K10).
Timepoint [1] 300468 0
Three months post-baseline
Secondary outcome [1] 330031 0
Change in severity of depressive symptoms as measured by the Indigenous adapted Patient Health Questionnaire (PHQ-9)
.
Timepoint [1] 330031 0
Three months post-baseline and six months post-baseline.
Secondary outcome [2] 330032 0
Change in QoL as measured by the EQ-5D (5 Level)
Timepoint [2] 330032 0
Three months post-baseline and six months post-baseline.
Secondary outcome [3] 330033 0
Adherence to treatment as measured by higher attendance at scheduled dialysis sessions and fewer hospitalisations
Timepoint [3] 330033 0
Three months post-baseline and six months post-baseline.
Secondary outcome [4] 331315 0
Cost effectiveness as measured by the cost per quality-adjusted life year (QALY) gained, and the cost per additional patient achieving a clinically meaningful change in the K10 at 3 months and 6 months.
Timepoint [4] 331315 0
Three months post-baseline and six months post-baseline.

Eligibility
Key inclusion criteria
Aboriginal or Torres Strait Islander.
Receiving haemodialyis treatment for minimum 6 months.
Able and willing to give informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those with a legal guardian in place for health-related decisions.
Those unable or unwilling to give informed consent.
Current cognitive impairment.
Visual impairment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A study statistician not directly involved in the analysis of study results will prepare the study randomisation code in a statistical database using random permutations that vary in size to prevent guessing, and stratified by site (Alice Springs, Darwin), K10 distress score (low/mild or moderate/severe) and access to dialysis on their home community (Yes or No/Don’t know)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/02/2017
Actual
1/03/2017
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
30/06/2019
Actual
Sample size
Target
156
Accrual to date
152
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 7101 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [2] 7102 0
Alice Springs Hospital - Alice Springs
Recruitment postcode(s) [1] 14857 0
0810 - Tiwi
Recruitment postcode(s) [2] 14858 0
0870 - Alice Springs

Funding & Sponsors
Funding source category [1] 295151 0
Government body
Name [1] 295151 0
NHMRC
Country [1] 295151 0
Australia
Primary sponsor type
Other
Name
Menzies School of Health Research
Address
John Mathews Building (Bldg 58)
Royal Darwin Hospital Campus
Rocklands Drv Casuarina NT 0810 Australia
Country
Australia
Secondary sponsor category [1] 293970 0
None
Name [1] 293970 0
Address [1] 293970 0
Country [1] 293970 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296498 0
Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research
Ethics committee address [1] 296498 0
PO Box 41096
Casuarina NT 0811
Ethics committee country [1] 296498 0
Australia
Date submitted for ethics approval [1] 296498 0
12/05/2016
Approval date [1] 296498 0
21/06/2016
Ethics approval number [1] 296498 0
HREC:2016-2599

Summary
Brief summary
Aboriginal and Torres Strait Islander people with chronic kidney disease (CKD) may suffer distress and poor mental health from living with a chronic illness, travelling away from family and country to receive treatment, poor access to housing and accommodation and big changes to their lifestyle.

The WICKD Study is a randomised controlled trial to test the effectiveness of a culturally-adapted, electronic mental health intervention (i.e. Motivational Care Planning (MCP) using the AIMhi Stay Strong App) in improving psychological distress, depressive symptoms and quality of life among Indigenous Australians on haemodialysis in the NT.

People with ESKD on dialysis are a group in which distress is likely to be unacceptably high, yet relatively untreated. The highly structured MCP intervention can be used by a wide range of healthcare workers and provides a high-fidelity treatment that can be integrated into a primary health care or chronic disease management setting. This coordinated approach, combining mental health prevention and intervention within a chronic disease setting could substantially reduce the impact of mental illness among Indigenous people with CKD and may have broad applicability across CKD and other chronic disease populations, both Indigenous and non-Indigenous. Demonstrating the effectiveness of this intervention will provide evidence for best practice intervention for managing distress for people on dialysis and facilitate integration of treatment for psychological distress within a chronic disease management setting.

HYPOTHESES
We hypothesize that:

Compared with the control interventions, MCP using the AIMhi Stay Strong App will elicit greater reductions in psychological distress as measured by the Kessler distress scale (K10) at 3 months post-baseline.

1. Compared with the control interventions, MCP using the AIMhi Stay Strong App will elicit:
a. Greater reductions in severity of depressive symptoms as measured by the Indigenous adapted Patient Health Questionnaire (PHQ-9) at 3 months post-baseline.
b. Improved QoL as measured by the EQ-5D (5 level) at 3 months post-baseline.
c. Greater adherence to treatment as measured by higher attendance at scheduled dialysis sessions and fewer hospitalisations at 3 months post-baseline
2. Similar improvements from baseline on psychological distress, depressive symptoms, QoL and adherence to dialysis will be seen in the three conditions at 6 months post-baseline, when all will have received the MCP intervention.
3. Compared with the control interventions, MCP using the AIMhi Stay Strong App will be cost effective, from the health service provider perspective, as measured by the cost per quality-adjusted life year (QALY) gained, and the cost per additional patient achieving a clinically meaningful improvement in the K10 at 3 months and 6 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69106 0
Dr Kylie Dingwall
Address 69106 0
Menzies School of Health Research
PO Box 4066, Alice Springs NT 0871
Country 69106 0
Australia
Phone 69106 0
+61 8 8951 4700
Fax 69106 0
+61 8 8951 4777
Email 69106 0
Kylie.Dingwall@menzies.edu.au
Contact person for public queries
Name 69107 0
Dr Kylie Dingwall
Address 69107 0
Menzies School of Health Research
PO Box 4066, Alice Springs NT 0871
Country 69107 0
Australia
Phone 69107 0
+61 8 8951 4700
Fax 69107 0
+61 8 8951 4777
Email 69107 0
Kylie.Dingwall@menzies.edu.au
Contact person for scientific queries
Name 69108 0
Dr Kylie Dingwall
Address 69108 0
Menzies School of Health Research
PO Box 4066, Alice Springs NT 0871
Country 69108 0
Australia
Phone 69108 0
+61 8 8951 4700
Fax 69108 0
+61 8 8951 4777
Email 69108 0
Kylie.Dingwall@menzies.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23456Study protocolDingwall, KM, Nagel, T, Hughes, JT, Kavanagh, DJ, Cass, A, Howard, K, . . . Majoni, SW (2019). Wellbeing intervention for chronic kidney disease (WICKD): a randomised controlled trial study protocol. BMC Psychology, 7(1), 2. doi:10.1186/s40359-018-0264-x https://link.springer.com/article/10.1186/s40359-018-0264-x 

Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3820Basic resultsNo 371512-(Uploaded-15-04-2021-14-20-53)-Basic results summary.pdf
4626Other filesNo DOI: 10.21203/rs.3.rs-107932/v1 371512-(Uploaded-15-04-2021-14-18-50)-Other results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of Wellbeing Intervention for Chronic Kidney Disease (WICKD): results of a randomised controlled trial.2021https://dx.doi.org/10.1186/s12882-021-02344-8
EmbaseThe stay strong app as a self-management tool for first nations people with chronic kidney disease: a qualitative study.2022https://dx.doi.org/10.1186/s12882-022-02856-x
N.B. These documents automatically identified may not have been verified by the study sponsor.