Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000229875
Ethics application status
Approved
Date submitted
8/12/2020
Date registered
4/03/2021
Date last updated
29/09/2022
Date data sharing statement initially provided
4/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The INJECT study - effect of a self-management intervention on needle fear in adults receiving haemodialysis.
Scientific title
Improving Management of Needle Distress during the Journey to Dialysis through Psychological EduCation and Training – The INJECT study (feasibility pilot).
Secondary ID [1] 302963 0
none
Universal Trial Number (UTN)
Trial acronym
The INJECT study
Linked study record
na

Health condition
Health condition(s) or problem(s) studied:
needle fear 320019 0
haemodialysis patients 320020 0
Condition category
Condition code
Renal and Urogenital 317941 317941 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot is a patient self-management intervention (INJECT) designed to empower patients to self-manage needle distress and to evaluate the feasibility and acceptability of the INJECT intervention. The intervention is based on Cognitive Behavioural Therapy (CBT) principles and it consists of:
1. Psychologist review to assess participant’s suitability for the intervention
Patients eligible for the study will have a consult with the psychologist (face to face, or via telehealth) who will perform brief psychological assessment, and administer several questionnaires to confirm suitability for the intervention. The psychologist will also provide an overview of the CBT self-management modules and inform patients that the research officer will invite them via email to participate in an online learning program, which they can access via smart phone, laptop, iPad etc.
2. Psychoeducation about needle distress and strategies patients can apply to manage this delivered via an online learning platform 'Open Learning'. Program contains of 6 modules that are completed in 6 weeks at a rate of 1 module/week or faster. Each module takes 10-15 minutes to complete. Modules will contain written text, images, short videos and short activities. Website analytics before and after surveys will be used to assess the feasibility and acceptability to the intervention. The educational material included in the intervention is designed for this study based on the Cognitive Behavioural principles.
3. Option to use virtual reality (VR) technology as distraction during dialysis
The psychologist will also inform the patient of the option to use Virtual Reality (VR) technology (as distraction) at dialysis during cannulation and have the headset in the consult for the patient to trial. Should the patient wish to use this in addition to completing the CBT modules, the psychologist will inform the Research officer of this, who will then inform the Nurse Unit Manager/nurse champion of the study at the patient’s dialysis site to coordinate delivery of VR at their subsequent dialysis sessions. VR goggles will have short relaxation videos (river, beach, nature videos) downloaded to help patients either during the cannulation process (needle insertion) or longer depending on their preference.
4. Support by practitioner nurses who have completed INJECT Nurse Education program
Nurse practitioners who have also completed the nurse education program on Central Adelaide Local Health Network Learning Central (entitled- INJECT Nurse Education Program) will be available to support patients.
5. Weekly contact by the research officer to discuss progress and address any concerns or issues

The duration of the intervention is 6 weeks. The goal of the intervention is to empower patients in self managing needle distress and to have access to tools/resources that will support skill building and be available to them as needed for revision and reinforcement of learning.
Intervention code [1] 319257 0
Behaviour
Intervention code [2] 319258 0
Treatment: Other
Comparator / control treatment
There is no control in this study as this project is a single armed non-randomised, feasibility study assessing the use of training modules for both nurses and haemodialysis patients undertaking educational program about needle distress, and strategies patients can apply to manage this.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325947 0
Patient feasibility and acceptability of the intervention measured as a composite of:
- Patient INJECT evaluation survey (at the end of 6 week intervention)
- Patient feasibility/acceptability questionnaire (immediately post the completion of online education program)
Timepoint [1] 325947 0
Patient INJECT evaluation survey (designed specifically for this study) - at the end of 6 week intervention
Primary outcome [2] 325949 0
patient feasibility/acceptability questionnaire (designed specifically for this study)
Timepoint [2] 325949 0
Immediately post the completion of online education program
Secondary outcome [1] 389634 0
Cannulation outcomes (data will be collected from the hospital electronic record system, as each cannulation is entered into the system by the nurse practitioner);
- miss cannulations i.e. missed veins in the initial attempt or subsequent attempt(s) of needling (at each dialysis session for the duration of the study)
Timepoint [1] 389634 0
throughout the duration of the study
Secondary outcome [2] 389635 0
Access surgical interventions, i.e any surgeries, transplantation, dialysis modality change etc (collected from the hospital electronic record system)
Timepoint [2] 389635 0

at each dialysis session for the duration of the study
Secondary outcome [3] 392457 0

Needle distress is measured as a composite of:
Dialysis fear of Injection questionnaire (DFIQ),
Hospital Anxiety and Depression Scale (HADS),
Blood/Injection fear Scale (BIFS) and
Managing needle distress questionnaire (MNDQ). This tool is developed specifically for this study to help evaluate the effectiveness of the intervention.
Timepoint [3] 392457 0
DFIQ, BIFS, HADS at baseline, 3 and 6 weeks post education intervention completion
MNDQ at baseline and 6 weeks post education intervention completion

Eligibility
Key inclusion criteria
Cohort is selected through dialysis physicians and nursing staff at Central and Northern Adelaide Renal and Transplantation Service (CNARTS) as those identified with high clinical index of suspicion to needle distress. Inclusion criteria:
• >18 years
• English speaking
• Commencing haemodialysis within study timeframe (incident patients)
• Already receiving haemodialysis
• Current AV fistula
• In-patient or outpatient
• DFIQ score >2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to give written consent
• Currently receiving psychological therapy/intervention for needle fear/distress
• Inability or unwillingness to complete patient self-management modules (e.g. due to literacy, vision impairment, cognitive deficits)
• DFIQ less than or equal to 2

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this study is a pilot study we are evaluating feasibility and acceptability of the INJECT intervention. Descriptive statistics will be employed to describe the cohort demographic and to report on feasibility/acceptability of the intervention. Data collected from the DFIQ, Managing needle distress, Blood Injury Symptom Scale and HADS questionnaires will be analysed by Wilcoxon matched pairs signed-rank tests (Stata software) to calculate changes in scores over the study data collection time points.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/03/2021
Actual
17/03/2021
Date of last participant enrolment
Anticipated
22/10/2021
Actual
2/11/2021
Date of last data collection
Anticipated
31/12/2021
Actual
6/01/2022
Sample size
Target
20
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 18162 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 18163 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 32163 0
5000 - Adelaide
Recruitment postcode(s) [2] 32164 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 307382 0
Hospital
Name [1] 307382 0
Clinical Project Grant reviewed by Royal Adelaide Hospital Research Committee
Country [1] 307382 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address

Royal Adelaide Hospital
Port Road
Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 308038 0
None
Name [1] 308038 0
none
Address [1] 308038 0
na
Country [1] 308038 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307469 0
Central Adelaide Local Health Network (CALHN) HREC
Ethics committee address [1] 307469 0
Level 3,
Roma Mitchell Building
136 North terrace, Adelaide SA 5000
Ethics committee country [1] 307469 0
Australia
Date submitted for ethics approval [1] 307469 0
12/11/2020
Approval date [1] 307469 0
23/12/2020
Ethics approval number [1] 307469 0
CALHN Reference number: 14047

Summary
Brief summary
The INJECT pilot feasibility study is comprised of a patient self-management psychological intervention to address needle distress in adults receiving haemodialysis foe end stage kidney failure. the intervention is based on Cognitive Behavioural Therapy (CBT) principles and it consists of 6 learning modules which will provide strategies patients can apply to manage needle distress. There is also an option to use virtual reality (VR) technology as a distraction during dialysis. Patients will be supported by nurse practitioners and a research officer during the intervention. The goal is for patients to feel empowered in self-managing needle distress and to have access to tools/resources that will support skill building and be available to them as needed for revision and reinforcement of learning.
This structured and novel intervention enhancing patient self-management and empowerment represents a major advance in addressing needle fear and reducing this aspect of the psychological burden experienced by dialysis patients. It can be translated rapidly into clinical practice and may benefit other patients receiving frequent needles as part of therapy, for example for cancer. It is inexpensive and feasible to deliver across sites. Partnership with patients and nurses at all stages ensures the intervention is useful and successfully implemented into clinical care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107338 0
A/Prof Shilpanjali Jesudason
Address 107338 0
Central Northern Adelaide Renal & Transplantation Service (CNARTS),
Speciality Medicine 1, Royal Adelaide Hospital
Level 7F 401, RAH
Port Road, ADELAIDE
South Australia. 5000
Country 107338 0
Australia
Phone 107338 0
+61 8 7074 0000
Fax 107338 0
Email 107338 0
[email protected]
Contact person for public queries
Name 107339 0
Gorjana Radisic
Address 107339 0
Central Northern Adelaide Renal & Transplantation Service (CNARTS),
Speciality Medicine 1, Royal Adelaide Hospital
Level 7F 401, RAH
Port Road, ADELAIDE
South Australia. 5000
Country 107339 0
Australia
Phone 107339 0
+61 8 70742558
Fax 107339 0
Email 107339 0
[email protected]
Contact person for scientific queries
Name 107340 0
Shilpanjali Jesudason
Address 107340 0
Central Northern Adelaide Renal & Transplantation Service (CNARTS),
Speciality Medicine 1, Royal Adelaide Hospital
Level 7F 401, RAH
Port Road, ADELAIDE
South Australia. 5000
Country 107340 0
Australia
Phone 107340 0
+61 8 7074 0000
Fax 107340 0
Email 107340 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No personal data will be shared in this study. All data (survey results) collected from the individual assessments will be de-identified and results will be analysed as a group and will be shared in any subsequent publication as a cohort and not individual data.
Research officer will allocate entry code to each participant and only some of the study team members will have access to this. Any personal data (in non-identifiable form) will be used only within the analysis of the group data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17212Study protocolThe protocol for this study has been published Radisic, G., Duncanson, E., Le Leu, R. et al. Improving management of needle distress during the journey to dialysis through psychological education and training—the INJECT study feasibility pilot protocol. Pilot Feasibility Stud 8, 28 (2022). https://doi.org/10.1186/s40814-022-00989-2https://doi.org/10.1186/s40814-022-00989-2 



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImproving management of needle distress during the journey to dialysis through psychological education and training-the INJECT study feasibility pilot protocol.2022https://dx.doi.org/10.1186/s40814-022-00989-2
N.B. These documents automatically identified may not have been verified by the study sponsor.