Trials
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Randomized Controlled Trial Multicenter Study Comparative Study
Tai Chi-based exercise program provided via telerehabilitation compared to home visits in a post-stroke population who have returned home without intensive rehabilitation: study protocol for a randomized, non-inferiority clinical trial.
The incidence of strokes in industrialized nations is on the rise, particularly in the older population. In Canada, a minority of individuals who have had a stroke actually receive intensive rehabilitation because most stroke patients do not have access to services or because their motor recovery was judged adequate to return home. Thus, there is a considerable need to organize home-based rehabilitation services for everyone who has had a stroke. To meet this demand, telerehabilitation, particularly from a service center to the patient's home, is a promising alternative approach that can help improve access to rehabilitation services once patients are discharged home. ⋯ ClinicalTrials.gov: NCT01848080.
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Randomized Controlled Trial Multicenter Study
Effectiveness and cost-effectiveness of a telehealth intervention to support the management of long-term conditions: study protocol for two linked randomized controlled trials.
As the population ages, more people are suffering from long-term health conditions (LTCs). Health services around the world are exploring new ways of supporting people with LTCs and there is great interest in the use of telehealth: technologies such as the Internet, telephone and home self-monitoring. ⋯ This study evaluates a complex telehealth intervention which combines evidence-based components and is delivered by an established healthcare organisation. The study will also analyse health economic information. In doing so, the study hopes to address some of the limitations of previous research by demonstrating the effectiveness and cost-effectiveness of a real world telehealth intervention.
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Randomized Controlled Trial Multicenter Study Comparative Study Pragmatic Clinical Trial
Advance telephone calls ahead of reminder questionnaires increase response rate in non-responders compared to questionnaire reminders only: The RECORD phone trial.
Postal questionnaires are simple and economical for collecting outcome data for randomised controlled trials (RCTs) but are prone to non-response. In the RECORD trial (a large pragmatic publicly funded RCT in UK) non-responders were sent a reminder and another questionnaire at 1 year, of which 40% were returned. In subsequent years we investigated the effect of an advance telephone call to non-responders on responses rate to reminder questionnaires and the next questionnaire 4 months later. ⋯ The telephone call resulted in a slight increase in response to the reminder questionnaire, however at 4 months later the proportion in the telephoned group responding was greater. This study suggests that pre-notification telephone calls may only be worthwhile if further questionnaires are to be sent out soon after reminder questionnaires.
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Randomized Controlled Trial
The early use of botulinum toxin in post-stroke spasticity: study protocol for a randomised controlled trial.
Patients surviving stroke but who have significant impairment of function in the affected arm are at more risk of developing pain, stiffness and contractures. The abnormal muscle activity, associated with post-stroke spasticity, is thought to be causally associated with the development of these complications. Treatment of spasticity is currently delayed until a patient develops signs of these complications. ⋯ This protocol is for a phase II study that aims to identify whether using OnabotulinumtoxinA (BoNT-A) in combination with physiotherapy early post stroke when initial abnormal muscle activity is neurophysiologically identified can prevent loss of range at joints and improve functional outcomes.The trial uses a screening phase to identify which people are appropriate to be included in a double blind randomised placebo-controlled trial. All patients admitted to Sandwell and West Birmingham NHS Trust Hospitals with a diagnosis of stroke will be screened to identify functional activity in the arm. Those who have no function will be appropriate for further screening. Patients who are screened and have abnormal muscle activity identified on EMG will be given electrical stimulation to forearm extensors for 3 months and randomised to have either injections of BoNT-A or normal saline. The primary outcome measure is the action research arm test - a measure of arm function. Further measures include spasticity, stiffness, muscle strength and fatigue as well as measures of quality of life, participation and caregiver strain.
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Recruitment of sufficient participants in an efficient manner is still widely acknowledged to be a major challenge to the mounting and completion of randomised controlled trials (RCTs). Few recruitment interventions have involved staff undertaking recruitment. This study aimed i) to understand the recruitment process from the perspective of recruiters actively recruiting RCT participants in six pragmatic RCTs, and ii) to identify opportunities for interventions to improve recruitment. ⋯ The synthesis showed that recruitment to these RCTs was a complex and fragile process. Clear obstacles were identified but hidden challenges related to recruiters' roles undermined recruitment, unbeknown to RCT CIs. Qualitative research can elicit and identify the hidden challenges. Training and support are then needed for recruiters to become more comfortable with the design and principles of RCTs, so that they can engage more openly with potentially eligible participants and create a more resilient recruitment process.