Challenges in conducting a randomized clinical trial of older people with chronic dizziness: Before, during and after vestibular rehabilitation
Introduction
Clinical trials with focus on older adults are of increasing importance [1], especially considering the growth of elderly population and the need for evidences to improve their care. Conducting a clinical trial involves protocol design, recruitment, protocol implementation, retention, analysis and dissemination of results [2]. Unfortunately, much attention is carried on the trial protocol design and results, i.e., the effect of an intervention on outcomes; while the other research stages are underrepresented on reports. This is a gap for evidence-based practice.
There are many inherent challenges in conducting clinical trials with samples composed by older adults [3], [4]. Ineligibility, due to the presence of comorbidities, disability and disease status, seems to be the greatest barrier to clinical trial enrollment among older adults [1]. Declining to participate is another obstacle in rehabilitation trial recruitment, and its major reasons refer to transportation difficulties (lack of money or distance), no accompany (caregiver or partner) to go to the intervention site, lack of interest and dislike of exercise [5]. Once under treatment, there are also hindrances related to the research protocol adherence, including numerous and time-consuming appointments and lack of accessibility [6]. In addition, the elderly population is more likely to have comorbidities that can lead to unstable conditions and to develop other illnesses resulting in non-attendance to the sessions, exclusion or dropout from the study protocol [3].
Vestibular rehabilitation (VR) is recommended for treating the symptoms of vestibular impairment [7]. Clinical trial results show that VR is beneficial for older adults in outcomes such as gait [8], body balance control [9] and activities of daily living [10], [11]. However, none out of nine randomized clinical trials about VR in middle-age and older adults did report the challenges in conducting the study or adverse effects related to intervention [12]. The authors from a systematic review regarding the effects of VR in unilateral peripheral vestibular dysfunction concluded that further investigation of patient compliance and adverse events are needed in this field [13].
Process evaluation of rehabilitation trials is understudied, particularly in older people with dizziness. And as well as, in research, physical therapists also treat patients with comorbidities and cope with their non-attendance or non-adherence on clinical practice. Thus, detailed description of the recruitment, attendance at therapy sessions, and adherence to the research protocol can assist with interpretation of the generalizability of the study findings [2], and so help practitioners to improve older patient care. Therefore, the purpose of this report is to describe the process of conducting a VR clinical trial (recruitment, attendance at therapy sessions, effects during therapy, adherence to the research protocol/home exercises and events on follow-up) for older people with chronic dizziness.
Section snippets
Material and methods
This is a process evaluation of a randomized controlled trial with a 3 month follow-up designed to verify the effectiveness of VR on older people with chronic dizziness. The study was approved by the Federal University of São Paulo Ethics Review Board (1656/09) and was registered in the Australian New Zealand Clinical Trials Registry (ACTRN 12610000018011). The protocol of this randomized trial was published previously [14].
A detailed timeline diagram of the variables assessed during the
Recruitment period
During the recruitment period (March 2010 to February 2012) a total of 144 elderly subjects were in the waiting list for VR treatment. From these, 38 (26.4%) were excluded at the telephone contact and 24 (16.7%) did not meet the inclusion criteria. The subjects excluded at the telephone contact had 74.6 ± 6.3 years, and were mostly women (86.8%, n = 33). The reasons for declining to participate in the trial were: death (n = 1), severe disability (n = 3), lack of transport to the clinical setting (n = 10),
Discussion
Unlike many other studies in rehabilitation field, this study revealed that the process of conducting a VR trial with elderly people faces several challenges. These challenges might also arise in the physiotherapist daily practice. Thus, trial reports with more detailed description, which goes beyond the outcome results, should approximate research to clinical practice.
In Geriatric and Gerontology research, the subjects (older adults) are often affected by comorbidities in addition to the
Acknowledgments
The study was supported by São Paulo Research Foundation (FAPESP, São Paulo, Brazil) reference number 2009/16908-6. Funding from FAPESP provided a PhD scholarship (NA RICCI) and materials to execute the VR protocols. We thank the staff and patients from the UNIFESP Otoneurology outpatient clinic for their contribution on this project.
References (37)
- et al.
Designing clinical trials in older people
Maturitas
(2011) - et al.
Recruitment and retention of elderly patients in clinical trials: issues and strategies
Am J Geriatr Psychiatry
(2001) - et al.
Randomized controlled trial of vestibular rehabilitation combined with cognitive–behavioral therapy for dizziness in older people
Otolaryngol Head Neck Surg
(2001) - et al.
Decreased ataxia and improved balance after vestibular rehabilitation
Otolaryngol Head Neck Surg
(2004) External validity of randomised controlled trials: “to whom do the results of this trial apply?”
Lancet
(2005)- et al.
An update on vestibular physical therapy
J Chin Med Assoc
(2013) - et al.
Participation of the elderly population in clinical trials: barriers and solutions
Cancer Control
(2014) - et al.
Recruiting older people to a randomised controlled dietary intervention trial — how hard can it be?
BMC Med Res Methodol
(2010) - et al.
Challenges in recruitment, attendance and adherence of acute stroke survivors to a randomized trial in Brazil: a feasibility study
Braz J Phys Ther
(2012) - et al.
Research participation among older adults with mobility limitation
Clin Nurs Res
(2009)
Vestibular rehabilitation improves daily life function
Am J Occup Ther
Effects of balance training in elderly people with nonperipheral vertigo and unsteadiness
Clin Rehabil
Adaptation exercises of vestibulo-ocular reflex on balance in the elderly
Intl Arch Otorhinolaryngol
Vestibular rehabilitation in elderly patients with benign paroxysmal positional vertigo
Rev Bras Otorrinolaringol
A systematic review about the effects of the vestibular rehabilitation in middle-age and older adults
Rev Bras Fisioter
Vestibular rehabilitation for unilateral peripheral vestibular dysfunction
Cochrane Database Syst Rev
Effects of conventional versus multimodal vestibular rehabilitation on functional capacity and balance control in older people with chronic dizziness from vestibular disorders: design of a randomized clinical trial
Trials
The Mini-Mental State Examination in a general population: impact of educational status
Arq Neuropsiquiatr
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