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Trial registered on ANZCTR


Registration number
ACTRN12618000376246
Ethics application status
Approved
Date submitted
6/03/2018
Date registered
13/03/2018
Date last updated
21/02/2020
Date data sharing statement initially provided
21/02/2020
Date results information initially provided
21/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Does an intervention for changing patients' efficacy expectations have an effect on the outcome of intravenous iron infusion?
Scientific title
The effect of optimizing patients' efficacy expectations on the outcome of intravenous iron infusion
Secondary ID [1] 294096 0
Nil known
Universal Trial Number (UTN)
U1111-1209-5794
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with iron deficiency anaemia 306681 0
Condition category
Condition code
Blood 305781 305781 0 0
Anaemia
Metabolic and Endocrine 306083 306083 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Optimizing patients' outcome expectations intervention

The current intervention is information-based and explains to the patient the role of iron and haemoglobin in the body and how they relate to each other, consequences of low levels of iron and haemoglobin, and how the intravenous iron infusion works. The expected positive consequences and benefits of an intravenous iron infusion (e.g., reduction in feeling tired) are emphasized and explained to the patient by using an analogy, Patients are asked to talk about areas of their life where they feel limited in functioning by their low iron level. Finally patients are reassured that they can expect experiencing the benefits of the iron infusion during the next few weeks.

The intervention is delivered immediately before the intravenous iron infusion by a candidate for a Masters degree in Health Psychology. The intervention is based on a standardized script and will be delivered once and individually in a face-to-face contact. It takes 5 minutes. Patients receive the intervention in the clinic where they have their appointment with an anaesthetist in order to receive an intravenous iron infusion.
Intervention code [1] 300375 0
Other interventions
Comparator / control treatment
General health information invervention

The control intervention explains to the participant in a general way how health behavior, general wellbeing, and an anaemia influence each other. A holistic view on health and health care is promoted. In general, factors and health behaviors which influence wellbeing are discussed with the patient: healthy diet, limited alcohol and tobacco consumption, physical activity and exercising, stress management, and a good work life balance. It is emphasized that taking care of oneself has a significant impact on health and wellbeing.

The control intervention is information-based and provided by the same person and in the same places and take approximately the same time as the experimental intervention described above. The control intervention is also delivered immediately before the intravenous iron infusion.
Control group
Active

Outcomes
Primary outcome [1] 304852 0
patients' self-rated symptoms of fatigue and loss of energy, assessed using the Chalder 14-Item Fatigue Scale and the Vitality subscale of the Short Form Survey (SF-36) of the Medical Outcomes Study
Timepoint [1] 304852 0
at 7 days and 4 weeks (primary timepoint) post intervention
Secondary outcome [1] 343849 0
patients' self-rated expectation of how effective the intravenous iron infusion will be in general, assessed using an 11-point numeric rating scale (NRS; 0=not at all effective, 10=extremely effective)
Timepoint [1] 343849 0
before and at the end of the intervention
Secondary outcome [2] 343850 0
patients' self-rated expectation of how effective the intravenous iron infusion will be in increasing the patients' energy levels, assessed using an 11-point NRS (0=not at all effective, 10=extremely effective)
Timepoint [2] 343850 0
before and at the end of the intervention
Secondary outcome [3] 343851 0
patients' self-rated expectation of how effective the intravenous iron infusion will be in improving the patients' day to day functioning, assessed using an 11-point NRS (0=not at all effective, 10=extremely effective)
Timepoint [3] 343851 0
before and at the end of the intervention

Eligibility
Key inclusion criteria
Participants will be included in this study if they:
- have an appointment in the local city hospital in order to receive an intravenous iron infusion
- are 18 years of age or over
- are able to understand and read proficiently in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no reasons for exclusion defined.

Study design
Purpose of the study
Educational / counselling / training
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 simple randomisation strategy will be applied using a randomisation table created by computer software. The randomisation will be conducted by a person being independent of the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
The assessor of the outcome expectations at the end of the intervention is not blinded, The assessor of the follow-up assessments (7 days and 4 weeks after the infusion) is blinded and independent of the study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power analysis conducted with G*Power showed that a total sample size of 52 patients is required to detect a medium effect size.

Data will be checked for the assumptions of parametric statistics before being analyzed in SPSS and SAS. An analysis of variance (ANOVA) will be conducted to examine group differences on continuous measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/04/2018
Actual
15/04/2018
Date of last participant enrolment
Anticipated
1/10/2018
Actual
1/10/2018
Date of last data collection
Anticipated
31/10/2018
Actual
31/10/2018
Sample size
Target
52
Accrual to date
Final
52
Recruitment outside Australia
Country [1] 9612 0
New Zealand
State/province [1] 9612 0
Auckland

Funding & Sponsors
Funding source category [1] 298731 0
University
Name [1] 298731 0
University of Auckland
Country [1] 298731 0
New Zealand
Primary sponsor type
Individual
Name
Keith Petrie
Address
Faculty of Medical and Health Sciences
School of Medicine
Department of Psychological Medicine
Auckland City Hospital
2 Park Road
Grafton, Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 297906 0
Individual
Name [1] 297906 0
Kerry Gunn
Address [1] 297906 0
Auckland DHB Anaesthesia
Auckland City Hospital
2 Park Road
Grafton, Auckland 1023
Country [1] 297906 0
New Zealand
Other collaborator category [1] 279950 0
Individual
Name [1] 279950 0
Maria Kleinstaeuber
Address [1] 279950 0
Faculty of Medical and Health Sciences
School of Medicine
Department of Psychological Medicine
Auckland City Hospital
2 Park Road
Grafton, Auckland 1023
Country [1] 279950 0
New Zealand
Other collaborator category [2] 279951 0
Individual
Name [2] 279951 0
Milly Akroyd
Address [2] 279951 0
Faculty of Medical and Health Sciences
School of Medicine
Department of Psychological Medicine
Auckland City Hospital
2 Park Road
Grafton, Auckland 1023
Country [2] 279951 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299674 0
Health and Disability Ethics Committees
Ethics committee address [1] 299674 0
Ministry of Health
PO Box 5013
Wellingston 6140
Ethics committee country [1] 299674 0
New Zealand
Date submitted for ethics approval [1] 299674 0
07/03/2018
Approval date [1] 299674 0
Ethics approval number [1] 299674 0
Ethics committee name [2] 299698 0
Auckland District Health Board
Ethics committee address [2] 299698 0
Auckland City Hospital
2 Park Road
Grafton, Auckland 1023
Ethics committee country [2] 299698 0
New Zealand
Date submitted for ethics approval [2] 299698 0
12/03/2018
Approval date [2] 299698 0
04/04/2018
Ethics approval number [2] 299698 0

Summary
Brief summary
Low haemoglobin is frequently associated with iron deficiency anaemia. In some patients with iron deficiency the first line treatment of oral iron is unsuitable or has been unsuccessful. For these patients intravenous (IV) infusion is used as an alternative treatment (Avni et al., 2016).
In health care context it was demonstrated that patients’ expectations of their treatment can have a significant impact on their treatment outcomes (Lafterton et al., 2016). Previous research demonstrated that brief interventions for optimizing patients’ outcome expectations significantly improve patients’ disability, mental quality of life, and fitness for work after interventions such as coronary artery bypass graft surgery (Rief et al., 2017).

The central aim of the current study is to examine if a short expectation optimizing intervention can also improve the effect of IV iron infusions with regard to patients’ fatigue. This research is a parallel design 2-arm randomized controlled intervention. The two conditions will include an intervention to optimize the expectation of reducing fatigue following and iron infusion and an active control group receiving general health information.

The primary outcome – fatigue and loss of energy – will be assessed with the Chalder 14-Item Fatigue Scale and with the Vitality subscale of the 36-Item Short Form Survey (SF-36) of the Medical Outcomes Study before the intervention and via phone 7 days and 4 weeks after infusion (blinded assessment). Participants’ efficacy expectations will be assessed before and at the end of the intervention with numeric rating scales. We hypothesise that indivicuals in the intervention group will show a greater reduction in fatigue at two time-points, 7 days and 4 weeks post IV iron infusion, and more positive outcome expectations at the end of the intervention compared to a control group.

We believe the findings from this study may have a significant impact on patients’ lives helping to further reduce the burden of fatigue and improve their quality of life. Findings from this proposed study will help build on current literature, highlighting the importance of optimizing patients’ expectations as a therapeutic tool.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81250 0
Prof Keith Petrie
Address 81250 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
School of Medicine
University of Auckland
Auckland Hospital Support Building
Grafton, Auckland 1023
Country 81250 0
New Zealand
Phone 81250 0
+6493737599 ext. 86564
Fax 81250 0
Email 81250 0
[email protected]
Contact person for public queries
Name 81251 0
Prof Keith Petrie
Address 81251 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
School of Medicine
University of Auckland
Auckland Hospital Support Building
Grafton, Auckland 1023
Country 81251 0
New Zealand
Phone 81251 0
+6493737599 ext. 86564
Fax 81251 0
Email 81251 0
[email protected]
Contact person for scientific queries
Name 81252 0
Prof Keith Petrie
Address 81252 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
School of Medicine
University of Auckland
Auckland Hospital Support Building
Grafton, Auckland 1023
Country 81252 0
New Zealand
Phone 81252 0
+6493737599 ext. 86564
Fax 81252 0
Email 81252 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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.