ANZCTR - Registration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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

Date results information initially provided

29/09/2022

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]

none

Universal Trial Number (UTN)

Trial acronym

The INJECT study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

needle fear

haemodialysis patients

Condition category

Condition code

Renal and Urogenital

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]

Behaviour

Intervention code [2]

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]

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]

Patient INJECT evaluation survey (designed specifically for this study) - at the end of 6 week intervention

Primary outcome [2]

patient feasibility/acceptability questionnaire (designed specifically for this study)

Timepoint [2]

Immediately post the completion of online education program

Secondary outcome [1]

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]

throughout the duration of the study

Secondary outcome [2]

Access surgical interventions, i.e any surgeries, transplantation, dialysis modality change etc (collected from the hospital electronic record system)

Timepoint [2]

at each dialysis session for the duration of the study

Secondary outcome [3]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [2]

The Queen Elizabeth Hospital - Woodville

Recruitment postcode(s) [1]

5000 - Adelaide

Recruitment postcode(s) [2]

5011 - Woodville

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Clinical Project Grant reviewed by Royal Adelaide Hospital Research Committee

Address [1]

Port Road
Adelaide, SA 5000

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Adelaide Hospital

Address

Royal Adelaide Hospital
Port Road
Adelaide, SA 5000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

none

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Adelaide Local Health Network (CALHN) HREC

Ethics committee address [1]

Level 3,
Roma Mitchell Building
136 North terrace, Adelaide SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/11/2020

Approval date [1]

23/12/2020

Ethics approval number [1]

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

A/Prof Shilpanjali Jesudason

Address

Central Northern Adelaide Renal & Transplantation Service (CNARTS),
Speciality Medicine 1, Royal Adelaide Hospital
Level 7F 401, RAH
Port Road, ADELAIDE
South Australia. 5000

Country

Australia

Phone

+61 8 7074 0000

Fax

[email protected]

Contact person for public queries

Name

Ms Gorjana Radisic

Address

Central Northern Adelaide Renal & Transplantation Service (CNARTS),
Speciality Medicine 1, Royal Adelaide Hospital
Level 7F 401, RAH
Port Road, ADELAIDE
South Australia. 5000

Country

Australia

Phone

+61 8 70742558

Fax

[email protected]

Contact person for scientific queries

Name

A/Prof Shilpanjali Jesudason

Address

Central Northern Adelaide Renal & Transplantation Service (CNARTS),
Speciality Medicine 1, Royal Adelaide Hospital
Level 7F 401, RAH
Port Road, ADELAIDE
South Australia. 5000

Country

Australia

Phone

+61 8 7074 0000

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
17212	Study protocol	The 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/s40814-022-00989-2	https://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

Source	Title	Year of Publication	DOI
Embase	Improving management of needle distress during the journey to dialysis through psychological education and training-the INJECT study feasibility pilot protocol.	2022	https://dx.doi.org/10.1186/s40814-022-00989-2

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically