The NKF-NUS hemodialysis trial protocol - a randomized controlled trial to determine the effectiveness of a self management intervention for hemodialysis patients

<p>Abstract</p> <p>Background</p> <p>Poor adherence to treatment is common in patients on hemodialysis which may increase risk for poor clinical outcomes and mortality. Self management interventions have been shown to be effective in improving compliance in other chronic populations. The aim of this trial is to evaluate the effectiveness of a recently developed group based self management intervention for hemodialysis patients compared to standard care.</p> <p>Methods/Design</p> <p>This is a multicentre parallel arm block randomized controlled trial (RCT) of a four session group self management intervention for hemodialysis patients delivered by health care professionals compared to standard care. A total of 176 consenting adults maintained on hemodialysis for a minimum of 6 months will be randomized to receive the self management intervention or standard care. Primary outcomes are biochemical markers of clinical status and adherence. Secondary outcomes include general health related quality of life, disease-specific quality of life, mood, self efficacy and self-reported adherence. Outcomes will be measured at baseline, immediately post-intervention and at 3 and 9 months post-intervention by an independent assessor and analysed on intention to treat principles with linear mixed-effects models across all time points. A qualitative component will examine which aspects of program participants found particularly useful and any barriers to change.</p> <p>Discussion</p> <p>The NKF-NUS intervention builds upon previous research emphasizing the importance of empowering patients in taking control of their treatment management. The trial design addresses weaknesses of previous research by use of an adequate sample size to detect clinically significant changes in biochemical markers, recruitment of a sufficiently large representative sample, a theory based intervention and careful assessment of both clinical and psychological endpoints at various follow up points. Inclusion of multiple dependent variables allows us to assess the broader impact on the intervention including both hard end points as well as patient reported outcomes. This program, if found to be effective, has the potential to be implemented within the existing renal services delivery model in Singapore, particularly as this is being delivered by health care professionals already working with hemodialysis patients in these settings who are specifically trained in facilitating self management in renal patients.</p> <p>Trial registration</p> <p>Current Controlled Trials <a href="http://www.controlled-trials.com/ISRTN31434033">ISRTN31434033</a></p

Living with, managing and minimising treatment burden in long term conditions: a systematic review of qualitative research.

BACKGROUND: 'Treatment burden', defined as both the workload and impact of treatment regimens on function and well-being, has been associated with poor adherence and unfavourable outcomes. Previous research focused on treatment workload but our understanding of treatment impact is limited. This research aimed to systematically review qualitative research to identify: 1) what are the treatment generated disruptions experienced by patients across all chronic conditions and treatments? 2) what strategies do patients employ to minimise these treatment generated disruptions? METHODS AND FINDINGS: The search strategy centred on: treatment burden and qualitative methods. Medline, CINAHL, Embase, and PsychINFO were searched electronically from inception to Dec 2013. No language limitations were set. Teams of two reviewers independently conducted paper screening, data extraction, and data analysis. Data were analysed using framework synthesis informed by Cumulative Complexity Model. Eleven papers reporting data from 294 patients, across a range of conditions, age groups and nationalities were included. Treatment burdens were experienced as a series of disruptions: biographical disruptions involved loss of freedom and independence, restriction of meaningful activities, negative emotions and stigma; relational disruptions included strained family and social relationships and feeling isolated; and, biological disruptions involved physical side-effects. Patients employed "adaptive treatment work" and "rationalised non-adherence" to minimise treatment disruptions. Rationalised non-adherence was sanctioned by health professionals at end of life; at other times it was a "secret-act" which generated feelings of guilt and impacted on family and clinical relationships. CONCLUSIONS: Treatments generate negative emotions and physical side effects, strain relationships and affect identity. Patients minimise these disruptions through additional adaptive work and/or by non-adherence. This affects physical outcomes and care relationships. There is a need for clinicians to engage with patients in honest conversations about treatment disruptions and the 'adhere-ability' of recommended regimens. Patient-centred practice requires management plans which optimise outcomes and minimise disruptions

Medication adherence perspectives in haemodialysis patients: a qualitative study

Background: End-stage kidney disease patients undergoing haemodialysis are prescribed with multiple complex regimens and are predisposed to high risk of medication nonadherence. The aims of this study were to explore factors associated with medication adherence, and, to examine the differential perspectives on medication-taking behaviour shown by adherent and nonadherent haemodialysis patients. Methods: A qualitative exploratory design was used. One-on-one semi-structured interviews were conducted with 30 haemodialysis patients at the outpatient dialysis facility in Hobart, Australia. Patient self-reported adherence was measured using 4-item Morisky Green Levine scale. Interview transcripts were thematically analysed and mapped against the World Health Organization (WHO) determinants of medication adherence. Results: Participants were 44–84 years old, and were prescribed with 4–19 medications daily. More than half of the participants were nonadherent to their medications based on self-reported measure (56.7%, n = 17). Themes mapped against WHO adherence model comprised of patient-related (knowledge, awareness, attitude, self-efficacy, action control, and facilitation); health system/ healthcare team related (quality of interaction, and mistrust and collateral arrangements); therapy-related (physical characteristics of medicines, packaging, and side effects); condition-related (symptom severity); and social/ economic factors (access to medicines, and relative affordability). Conclusions: Patients expressed a number of concerns that led to nonadherence behaviour. Many of the issues identified were patient-related and potentially modifiable by using psycho-educational or cognitive-behavioural interventions. Healthcare professionals should be more vigilant towards identifying these concerns to address adherence issues. Future research should be aimed at understanding healthcare professionals’ perceptions and practices of assessing medication adherence in dialysis patients that may guide intervention to resolve this significant issue of medication non-adherence