None listed
Conditions
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.
Interventions
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
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.
Sponsors
Keith Petrie
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
There are no reasons for exclusion defined.
Outcome results
None listed