scholarly journals Safer cycling in older age (SiFAr): a protocol of a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Hanna Maria Siebentritt ◽  
Veronika Keppner ◽  
Sabine Britting ◽  
Robert Kob ◽  
Anja Rappl ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Community Dwelling ◽  
Older Age ◽  
Control Group ◽  
Positive Effects ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Cycling has positive effects on health and the proportion of older cyclists is rising. However, the risk for older adults to be injured or killed by a bicycle accident increases. The aim of the ongoing project “Safer Cycling in Older Age (SiFAr)” is to promote safer cycling in community-dwelling older adults with a structured, multi-component exercise training. Methods SiFAr is a randomized, controlled trial with a duration of 3 months for the intervention and a 6–9 months follow-up. We address community-dwelling persons aged 65 years and older living in the area Nürnberg-Fürth-Erlangen (Germany) who are either 1) beginners with the e-bike or 2) feeling self-reported unsteadiness when cycling or 3) uptaking cycling after a longer break. Long-term, experienced cyclists without subjectively reported limitations or worries when cycling are excluded. Participants are either randomized 1:1 to an intervention group (IG; receiving multi-component exercise program related to cycling, MEPC) or an active control group (aCG; receiving health and bicycle-related presentations, HRP). The purpose of this study is to investigate if the cycling competence of the IG will improve compared to the aCG. The cycling competence as primary outcome is tested not blinded in a standardized cycle course prior and after the intervention period, which consists of variant tasks requiring motor and cognitive skills related to traffic situations in daily life. Additional assessments such as physical functioning, quality of life, fear of falling, questionnaires regarding cycling behavior are obtained. To investigate the primary objective, regression analyses with difference of errors in the cycling course as independent variable and group as dichotomous dependent variable adjusted for covariates (sex, bicycle type) will be performed. The trial design is described in the present manuscript, using the extended CONSORT checklist for reporting pragmatic trials. Discussion Since there is a lack of cycling-related interventions for older people, SiFAr aims to evaluate a standardized intervention to enhance cycling safety. The results of the SiFAr trial could contribute to the implementation of an evaluated cycling course concept promoting mobility and independence of older adults. Trial registration This study was registered with clinicaltrials.gov: NCT04362514 on April 27, 2020

scholarly journals Short-term balance training and acute effects on postural sway in balance-deficient older adults: a randomized controlled trial

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Niklas Sörlén ◽  
Andreas Hult ◽  
Peter Nordström ◽  
Anna Nordström ◽  
Jonas Johansson
Keyword(s):  
Older Adults ◽  
Postural Sway ◽  
Intervention Group ◽  
Community Dwelling ◽  
Control Group ◽  
Positive Effects ◽  
Randomized Controlled ◽  
Eyes Closed ◽  
Balance Exercise

Abstract Background We aimed to determine the effectiveness of 4 weeks of balance exercise compared with no intervention on objectively measured postural sway. Methods This was a single-center parallel randomized controlled, open label, trial. A six-sided dice was used for allocation at a 1:1-ratio between exercise and control. The trial was performed at a university hospital clinic in Sweden and recruited community-dwelling older adults with documented postural instability. The intervention consisted of progressively challenging balance exercise three times per week, during 4 weeks, with follow-up at week five. Main outcome measures were objective postural sway length during eyes open and eyes closed conditions. Results Sixty-five participants aged 70 years (balance exercise n = 32; no intervention n = 33) were randomized. 14 participants were excluded from analysis because of early dropout before follow-up at week five, leaving 51 (n = 22; n = 29) participants for analysis. No significant differences were detected between the groups in any of the postural sway outcomes. Within-group analyses showed significant improvements in hand grip strength for the intervention group, while Timed Up & Go improvements were comparable between groups but only statistically significant in the control group. Conclusions Performing balance exercise over a four-week intervention period did not acutely improve postural sway in balance-deficient older adults. The lower limit in duration and frequency to achieve positive effects remains unclear. Trial registration Clinical trials NCT03227666, July 24, 2017, retrospectively registered.

scholarly journals Medication Adherence Support of an In-home Electronic Medication Dispensing System for Individuals living with Chronic Conditions: A Pilot Randomized Controlled Trial

2021 ◽  
Author(s):  
Mubashir Arain ◽  
Armghan Ahmad ◽  
Venus Chiu ◽  
Lorena Kembel
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Chronic Conditions ◽  
Controlled Trial ◽  
Medication Management ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Abstract Background: Medication adherence is challenging for older adults due to factors such as the number of medications, dosing schedule, and the duration of drug therapy. The objective of this study was to examine the effectiveness of an in-home electronic medication dispensing system (MDS) on improving medication adherence and health perception in older adults with chronic conditions. Methods: A pilot Randomized Controlled Trial (RCT) was conducted using a two-arm parallel assignment model. The intervention group used an MDS as their medication management method. The control group continued to use their current methods of medication management. Block randomization was used to assign participants into the intervention or control group. The inclusion criteria included 1) English speaking 2) age 50 and over 3) diagnosed with one or more chronic condition(s) 4) currently taking five or more oral medications 5) City of Calgary resident. Participants were recruited from a primary care clinic in Alberta, Canada. The study was open label where knowledge about group assigned to participants after randomization was not withheld. Medication adherence was captured over a continuous, six-month period and analyzed using Intention-to-Treat (ITT) analysis. Results: A total of 91 participants were assessed for eligibility and 50 were randomized into the two groups. The number of participants analyzed for ITT was 23 and 25 in the intervention and control group, respectively. Most of the demographic characteristics were comparable in the two groups except mean age of the intervention group, which was higher compared to the control group (63.96±7.86 versus 59.52±5.93, p-value=0.03). The average recorded adherence over 26 weeks was significantly higher in the intervention group than the control group (98.35%±2.15% versus 91.17%±9.76%, p<0.01). The self-rated medication adherence in the intervention group also showed a significant increase from baseline to 6-month (7.63±1.63 versus 9.13±0.81, p<0.01). The control group showed a non-significant increase (7.20±1.74 versus 8.27±2.09, p=0.07). Conclusion: MDS can be an effective, long-term solution to medication non-adherence in older adults experiencing chronic conditions and taking multiple medications. The technology induces better consistency and improvement in medication taking behaviour than simple, non-technological intervention. Trial Registration: Registered with ClinicalTrials.gov on April 09, 2020 with identifier NCT04339296.

scholarly journals Medication Adherence Support of an in-home Electronic Medication Dispensing System for Individuals Living With Chronic Conditions: A Randomized Controlled Trial

2020 ◽  
Author(s):  
Mubashir Arain ◽  
Armghan Ahmad ◽  
Venus Chiu ◽  
Lorena Kembel
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Chronic Conditions ◽  
Controlled Trial ◽  
Medication Management ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Medication Dispensing

Abstract Background: Medication adherence is challenging for older adults due to factors, such as the number of medications, dosing schedule, and the duration of drug therapy. The objective of this study was to examine the effectiveness of an in-home electronic medication dispensing system (MDS) on improving medication adherence and health perception in older adults with chronic conditions.Methods: A Randomized Controlled Trial (RCT) was conducted using a two-arm parallel assignment model. The intervention group used an MDS as their medication management method. The control group continued to use their current methods of medication management. Block randomization was used to assign participants into the intervention or control group. The inclusion criteria included 1) English speaking 2) age 50 and over 3) diagnosed with one or more chronic condition(s) 4) currently taking five or more oral medications 5) City of Calgary resident. Participants were recruited from a primary care clinic in Alberta, Canada. The study was open label where knowledge about group assigned to participants after randomization was not withheld. Medication adherence was captured over a continuous, six-month period and analyzed using Intention-to-Treat (ITT) analysis.Results: A total of 91 participants were assessed for eligibility and 50 were randomized into the two groups. The number of participants analyzed for ITT was 23 and 25 in the intervention and control group, respectively. Most of the demographic characteristics were comparable in the two groups except mean age of the intervention group, which was higher compared to the control group (63.96±7.86 versus 59.52±5.93, p-value=0.03). The average recorded adherence over 26 weeks was significantly higher in the intervention group than the control group (98.35%±2.15% versus 91.17%±9.76%, p<0.01). The self-rated medication adherence in the intervention group also showed a significant increase from baseline to 6-month (7.63±1.63 versus 9.13±0.81, p<0.01). The control group showed a non-significant increase (7.20±1.74 versus 8.27±2.09, p=0.07).Conclusion: MDS can be an effective, long-term solution to medication non-adherence in older adults experiencing chronic conditions and taking multiple medications. The technology induces better consistency and improvement in medication taking behaviour than simple, non-technological intervention.Trial Registration: Registered with ClinicalTrials.gov on April 09, 2020 with identifier NCT04339296.

scholarly journals Assessing the Efficacy of an Educational Smartphone or Tablet App With Subdivided and Interactive Content to Increase Patients’ Medical Knowledge: Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Thomas Timmers ◽  
Loes Janssen ◽  
Yvette Pronk ◽  
Babette C van der Zwaard ◽  
Sander Koëter ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Treatment Options ◽  
Intervention Group ◽  
Control Group ◽  
Perceived Knowledge ◽  
Actual Knowledge ◽  
Positive Effects ◽  
Randomized Controlled

BACKGROUND Modern health care focuses on shared decision making (SDM) because of its positive effects on patient satisfaction, therapy compliance, and outcomes. Patients’ knowledge about their illness and available treatment options, gained through medical education, is one of the key drivers for SDM. Current patient education relies heavily on medical consultation and is known to be ineffective. OBJECTIVE This study aimed to determine whether providing patients with information in a subdivided, categorized, and interactive manner via an educational app for smartphone or tablet might increase the knowledge of their illness. METHODS A surgeon-blinded randomized controlled trial was conducted with 213 patients who were referred to 1 of the 6 Dutch hospitals by their general practitioner owing to knee complaints that were indicative of knee osteoarthritis. An interactive app that, in addition to standard care, actively sends informative and pertinent content to patients about their illness on a daily basis by means of push notifications in the week before their consultation. The primary outcome was the level of perceived and actual knowledge that patients had about their knee complaints and the relevant treatment options after the intervention. RESULTS In total, 122 patients were enrolled in the control group and 91 in the intervention group. After the intervention, the level of actual knowledge (measured on a 0-36 scale) was 52% higher in the app group (26.4 vs 17.4, P<.001). Moreover, within the app group, the level of perceived knowledge (measured on a 0-25 scale) increased by 22% during the week within the app group (from 13.5 to 16.5, P<.001), compared with no gain in the control group. CONCLUSIONS Actively offering patients information in a subdivided (per day), categorized (per theme), and interactive (video and quiz questions) manner significantly increases the level of perceived knowledge and demonstrates a higher level of actual knowledge, compared with standard care educational practices. CLINICALTRIAL International Standard Randomized Controlled Trial Number ISRCTN98629372; http://www.isrctn.com/ISRCTN98629372 (Archived by WebCite at http://www.webcitation.org/73F5trZbb)

scholarly journals Medication Adherence Support of an In-home Electronic Medication Dispensing System for Individuals living with Chronic Conditions: A Pilot Randomized Controlled Trial

2020 ◽  
Author(s):  
Mubashir Arain ◽  
Armghan Ahmad ◽  
Venus Chiu ◽  
Lorena Kembel
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Chronic Conditions ◽  
Controlled Trial ◽  
Medication Management ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Abstract Background: Medication adherence is challenging for older adults due to factors, such as the number of medications, dosing schedule, and the duration of drug therapy. The objective of this study was to examine the effectiveness of an in-home electronic medication dispensing system (MDS) on improving medication adherence and health perception in older adults with chronic conditions.Methods: A pilot Randomized Controlled Trial (RCT) was conducted using a two-arm parallel assignment model. The intervention group used an MDS as their medication management method. The control group continued to use their current methods of medication management. Block randomization was used to assign participants into the intervention or control group. The inclusion criteria included 1) English speaking 2) age 50 and over 3) diagnosed with one or more chronic condition(s) 4) currently taking five or more oral medications 5) City of Calgary resident. Participants were recruited from a primary care clinic in Alberta, Canada. The study was open label where knowledge about group assigned to participants after randomization was not withheld. Medication adherence was captured over a continuous, six-month period and analyzed using Intention-to-Treat (ITT) analysis.Results: A total of 91 participants were assessed for eligibility and 50 were randomized into the two groups. The number of participants analyzed for ITT was 23 and 25 in the intervention and control group, respectively. Most of the demographic characteristics were comparable in the two groups except mean age of the intervention group, which was higher compared to the control group (63.96±7.86 versus 59.52±5.93, p-value=0.03). The average recorded adherence over 26 weeks was significantly higher in the intervention group than the control group (98.35%±2.15% versus 91.17%±9.76%, p<0.01). The self-rated medication adherence in the intervention group also showed a significant increase from baseline to 6-month (7.63±1.63 versus 9.13±0.81, p<0.01). The control group showed a non-significant increase (7.20±1.74 versus 8.27±2.09, p=0.07).Conclusion: MDS can be an effective, long-term solution to medication non-adherence in older adults experiencing chronic conditions and taking multiple medications. The technology induces better consistency and improvement in medication taking behaviour than simple, non-technological intervention.Trial Registration: Registered with ClinicalTrials.gov on April 09, 2020 with identifier NCT04339296.

scholarly journals A Home-Based Individual Cognitive Stimulation Program for Older Adults With Cognitive Impairment: A Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Rosa Silva ◽  
Elzbieta Bobrowicz-Campos ◽  
Paulo Santos-Costa ◽  
Ana Rita Cruz ◽  
João Apóstolo
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Cognitive Impairment ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cognitive Stimulation ◽  
Attrition Rate ◽  
Control Group ◽  
Randomized Controlled ◽  
Home Based

Objective: This study aims to assess the feasibility and meaningfulness of a home-based individual cognitive stimulation (iCS) program delivered by caregivers to persons with cognitive impairment (PwCIs). It also aims to assess whether the older adults receiving this program improved their cognitive, neuropsychiatric, and depressive symptoms and quality of life and whether their caregivers improved their mental and physical health.Methods: A randomized controlled trial (RCT) was conducted with PwCI-caregiver dyads recruited from the community. Participants were allocated to two groups: intervention (n = 28) and control (n = 24). The intervention group received the European Portuguese version of the Individual Cognitive Stimulation Program—Making a Difference 3 (MD3-P). The control group received usual care. The iCS therapy program was implemented three times a week for 12 weeks. Caregivers were supported by the researchers to deliver the sessions at home. Participants were assessed at baseline and at the end of the intervention (week 13). Feasibility and meaningfulness were assessed through the attrition rate, adherence, and degree of satisfaction with the sessions. Four interviews were conducted (after week 13) to understand participants’ experiences.Results: The attrition rate was 23.1%. The dyads reported that they did not have high expectations about the iCS program before starting the study. Nevertheless, as the program evolved, caregivers noted that their family members had improved some areas of functioning. Intention-to-treat analysis based on group differences revealed a significant improvement in PwCIs’ cognition, specifically in their orientation and ability to follow commands. The intervention had no impact on other variables such as caregivers’ physical and mental health.Conclusion: The iCS program implemented by caregivers showed promising results in improving PwCIs’ cognition. The participants who completed the intervention attributed a positive meaning to the MD3-P, confirming it as a valid non-pharmacological therapeutic approach to reducing frailty in PwCIs in community settings.Clinical Trial Registration:www.ClinicalTrials.gov, identifier [NCT03514095].

scholarly journals Medication adherence support of an in-home electronic medication dispensing system for individuals living with chronic conditions: a pilot randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mubashir Aslam Arain ◽  
Armghan Ahmad ◽  
Venus Chiu ◽  
Lorena Kembel
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Chronic Conditions ◽  
Controlled Trial ◽  
Medication Management ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Abstract Background Medication adherence is challenging for older adults due to factors such as the number of medications, dosing schedule, and the duration of drug therapy. The objective of this study was to examine the effectiveness of an in-home electronic medication dispensing system (MDS) on improving medication adherence and health perception in older adults with chronic conditions. Methods A pilot Randomized Controlled Trial (RCT) was conducted using a two-arm parallel assignment model. The intervention group used an MDS as their medication management method. The control group continued to use their current methods of medication management. Block randomization was used to assign participants into the intervention or control group. The inclusion criteria included 1) English speaking 2) age 50 and over 3) diagnosed with one or more chronic condition(s) 4) currently taking five or more oral medications 5) City of Calgary resident. Participants were recruited from a primary care clinic in Alberta, Canada. The study was open-label where knowledge about group assigned to participants after randomization was not withheld. Medication adherence was captured over a continuous, six-month period and analyzed using Intention-to-Treat (ITT) analysis. Results A total of 91 participants were assessed for eligibility and 50 were randomized into the two groups. The number of participants analyzed for ITT was 23 and 25 in the intervention and control group, respectively. Most of the demographic characteristics were comparable in the two groups except the mean age of the intervention group, which was higher compared to the control group (63.96 ± 7.86 versus 59.52 ± 5.93, p-value = 0.03). The average recorded adherence over 26 weeks was significantly higher in the intervention group than the control group (98.35% ± 2.15% versus 91.17% ± 9.76%, p < 0.01). The self-rated medication adherence in the intervention group also showed a significant increase from baseline to 6-month (Z=-2.65, p < 0.01). The control group showed a non-significant increase (Z=-1.79, p = 0.07). Conclusion The MDS can be an effective, long-term solution to medication non-adherence in older adults experiencing chronic conditions and taking multiple medications. The technology induces better consistency and improvement in medication taking behaviour than simple, non-technological intervention. Trial registration Registered with ClinicalTrials.gov on April 09, 2020 with identifier NCT04339296.

scholarly journals The Effect of Pillbox Use on Medication Adherence Among Elderly Patients: A Randomized Controlled Trial

2020 ◽  
Vol 9 (1) ◽  
pp. 38-43
Author(s):  
Ashraf Mehdinia ◽  
Marzieh Loripoor ◽  
Mahlagha Dehghan ◽  
Shahin Heidari
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Cardiovascular Diseases ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
The Mean ◽  
Poor Medication Adherence

Background: Poor medication adherence may cause unfortunate consequences such as disease progression and even death, particularly in older adults. This study aimed to evaluate the effect of pillbox use on medication adherence among older adults with cardiovascular diseases. Materials and Methods: This study was conducted as a two-group randomized controlled trial in a clinic in Kerman, Iran in 2017. Participants included seventy patients who were randomly allocated to either a control or an intervention group. The patients in the intervention group were verbally educated to manage their medications using a pillbox for four consecutive weeks while their counterparts received their medications without the use of any drug reminders. Results: The mean score of all participants’ medication adherence was 4.02±2.19 at the beginning of the study. Medication adherence significantly improved in the intervention group during the study (P<0.001) while it remained poor in the control group (P>0.99). Finally, medication adherence was significantly better in the intervention group compared to the control group at the end of the study (P=0.001). Conclusion: In general, pillbox use can promote medication adherence in older adults with cardiovascular diseases thus it is recommended for improving medication adherence and minimizing the consequences of non-adherence.

Impact of the WHO depression guideline on patient care by psychiatrists: A randomized controlled trial

2008 ◽  
Vol 23 (6) ◽  
pp. 403-408 ◽  
Author(s):  
Michel Linden ◽  
Anja Westram ◽  
Lutz G. Schmidt ◽  
Clemenz Haag
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Training Group ◽  
Control Group ◽  
Negative Effects ◽  
Course Of Illness ◽  
Positive Effects ◽  
Randomized Controlled ◽  
Information Group

AbstractBackgroundScientific literature reviews aim to summarize the state of knowledge and published empirical evidence. In contrast, medical guidelines are intervention tools that aim to improve physician behaviour and patient outcome. They can have positive effects, but they can also have negative effects. Their effects must be tested by research.MethodsIn a randomized controlled trial, 103 psychiatrists in private practice were either provided with the WHO depression guideline only (information group), or provided with the WHO depression guideline and trained for one day in this guideline (intervention group), or left uninformed (control group). They then treated a total of 497 patients according to individual clinical considerations and the needs of the patients. Observation of routine treatment lasted 12 weeks. Physicians and patients documented the course of illness and treatment, including the patient–physician interaction.ResultsPsychiatrists in the intervention group saw more psychosocial stressors in their patients, prescribed higher dosages of medication, had fewer drop-outs, and rated treatment outcome as better. The ratings of patient–physician interactions indicated more strain in their relationships.ConclusionsThe results show both positive and negative effects of guideline exposure, but only in the training group and not in the information group. Guidelines should be empirically tested before being called “evidence based”. Every guideline should also explain how it can or must be implemented in order to become effective.

Effect of Reactive Balance Training Involving Repeated Slips and Trips on Balance Recovery Among Older Adults: A Blinded Randomized Controlled Trial

2019 ◽  
Vol 74 (9) ◽  
pp. 1489-1496 ◽  
Author(s):  
Yoshiro Okubo ◽  
Daina L Sturnieks ◽  
Matthew A Brodie ◽  
Lionne Duran ◽  
Stephen R Lord
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Balance Training ◽  
Control Group ◽  
Balance Recovery ◽  
Randomized Controlled ◽  
Post Assessment ◽  
Reactive Balance

Abstract Background This study examined whether reactive balance training (exposures to slips and trips) could improve balance recovery and reduce perturbation-induced falls among older adults. Methods Forty-four community-dwelling older adults participated in a parallel, blinded randomized controlled trial conducted in a research institute in Sydney, Australia in 2017–2018 (ACTRN12617000564358). The intervention group (n = 22) underwent three 40 minutes sessions (total 120 minutes) that exposed them to (1) 20 trips, (2) 20 slips, and (3) 10 trips and 10 slips in mixed order, over 2 days. The control group (n = 22) received one 40 minutes session of sham training. The primary outcome was falls (>30% body weight in harness) when exposed to trips and slips at post-assessment. Results At post-assessment, a total of 51 falls (23 and 27 falls from induced slips and trips, respectively) were recorded in the laboratory. Relative to the control group, the intervention group experienced fewer total falls (rate ratio [RR] = 0.40, 95% confidence interval [CI] = 0.22–0.76), slip falls (RR = 0.33, 95% CI = 0.12–0.90) and trip falls (RR = 0.49, 95% CI = 0.21–1.12). Eight participants reported adverse events (5 in the intervention group and 3 in the control group) which were related mainly to discomfort caused by a suboptimal harness used in the initial stages of the trial. Conclusions The reactive balance training reduced perturbation-induced falls by 60% indicating improved balance recovery from trips and slips. A comfortable safety harness system is essential to prevent discomfort. Reactive balance training may complement traditional exercise programs in fall prevention interventions.

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