scholarly journals Yoga and Aerobic Dance for Pain Management in Juvenile Idiopathic Arthritis: Protocol for a Pilot Randomized Controlled Trial

10.2196/12823 ◽  
2020 ◽  
Vol 9 (7) ◽  
pp. e12823 ◽  
Author(s):  
Karine Toupin April ◽  
Jennifer Stinson ◽  
Sabrina Cavallo ◽  
Laurie Proulx ◽  
George A Wells ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pain Management ◽  
Training Program ◽  
Controlled Trial ◽  
Female Adolescents ◽  
Control Group ◽  
Aerobic Dance ◽  
Randomized Controlled ◽  
Dance Training ◽  
Pilot Randomized Controlled Trial

Background Juvenile idiopathic arthritis (JIA) is one of the most common types of arthritis among children. According to JIA guidelines for physical activity (PA), structured PA interventions led to improved health outcomes. However, many PA programs, such as yoga and aerobic dance, have not been studied in this population despite being popular among youth. Web-based PA programs could provide patients with accessible and affordable interventions. Objective The primary aims of the proposed pilot randomized controlled trial (RCT) are to examine (1) the feasibility of conducting a full-scale RCT to evaluate the effectiveness of two popular types of PA: a yoga training program and an aerobic dance training program, in female adolescents (aged 13-18 years) with JIA compared with an electronic pamphlet control group; and (2) the acceptability of these interventions. Methods A three-arm prospective randomized open-label study with a parallel group design will be used. A total of 25 female adolescents with JIA who have pain will be randomized in a ratio of 2:2:1 to one of the 3 groups: (1) online yoga training program (group A: n=10); (2) online aerobic dance training program (group B: n=10); and (3) electronic pamphlet control group (group C: n=5). Participants in groups A and B will complete 3 individual 1-hour sessions per week using online exercise videos, as well as a 1-hour virtual group session per week using a videoconferencing platform for 12 weeks. Participants from all groups will have access to an electronic educational pamphlet on PA for arthritis developed by the Arthritis Society. All participants will also take part in weekly online consultations with a research coordinator and discussions on Facebook with participants from their own group. Feasibility (ie, recruitment rate, self-reported adherence to the interventions, dropout rates, and percentage of missing data), acceptability, and usability of Facebook and the videoconferencing platform will be assessed at the end of the program. Pain intensity, participation in general PA, morning stiffness, functional status, fatigue, self-efficacy, patient global assessment, disease activity, and adverse events will be assessed using self-administered electronic surveys at baseline and then weekly until the end of the 12-week program. Results This pilot RCT has been funded by the Arthritis Health Professions Association. This protocol was approved by the Children’s Hospital of Eastern Ontario Research Ethics Board (#17/08X). As of May 11, 2020, recruitment and data collection have not started. Conclusions To our knowledge, this is the first study to evaluate the effectiveness of yoga and aerobic dance as pain management interventions for female adolescents with JIA. The use of online programs to disseminate these 2 PA interventions may facilitate access to alternative methods of pain management. This study can lead to a full-scale RCT. International Registered Report Identifier (IRRID) PRR1-10.2196/12823

scholarly journals Yoga and Aerobic Dance for Pain Management in Juvenile Idiopathic Arthritis: Protocol for a Pilot Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Karine Toupin April ◽  
Jennifer Stinson ◽  
Sabrina Cavallo ◽  
Laurie Proulx ◽  
George A Wells ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pain Management ◽  
Training Program ◽  
Controlled Trial ◽  
Female Adolescents ◽  
Control Group ◽  
Aerobic Dance ◽  
Randomized Controlled ◽  
Dance Training ◽  
Pilot Randomized Controlled Trial

BACKGROUND Juvenile idiopathic arthritis (JIA) is one of the most common types of arthritis among children. According to JIA guidelines for physical activity (PA), structured PA interventions led to improved health outcomes. However, many PA programs, such as yoga and aerobic dance, have not been studied in this population despite being popular among youth. Web-based PA programs could provide patients with accessible and affordable interventions. OBJECTIVE The primary aims of the proposed pilot randomized controlled trial (RCT) are to examine (1) the feasibility of conducting a full-scale RCT to evaluate the effectiveness of two popular types of PA: a yoga training program and an aerobic dance training program, in female adolescents (aged 13-18 years) with JIA compared with an electronic pamphlet control group; and (2) the acceptability of these interventions. METHODS A three-arm prospective randomized open-label study with a parallel group design will be used. A total of 25 female adolescents with JIA who have pain will be randomized in a ratio of 2:2:1 to one of the 3 groups: (1) online yoga training program (group A: n=10); (2) online aerobic dance training program (group B: n=10); and (3) electronic pamphlet control group (group C: n=5). Participants in groups A and B will complete 3 individual 1-hour sessions per week using online exercise videos, as well as a 1-hour virtual group session per week using a videoconferencing platform for 12 weeks. Participants from all groups will have access to an electronic educational pamphlet on PA for arthritis developed by the Arthritis Society. All participants will also take part in weekly online consultations with a research coordinator and discussions on Facebook with participants from their own group. Feasibility (ie, recruitment rate, self-reported adherence to the interventions, dropout rates, and percentage of missing data), acceptability, and usability of Facebook and the videoconferencing platform will be assessed at the end of the program. Pain intensity, participation in general PA, morning stiffness, functional status, fatigue, self-efficacy, patient global assessment, disease activity, and adverse events will be assessed using self-administered electronic surveys at baseline and then weekly until the end of the 12-week program. RESULTS This pilot RCT has been funded by the Arthritis Health Professions Association. This protocol was approved by the Children’s Hospital of Eastern Ontario Research Ethics Board (#17/08X). As of May 11, 2020, recruitment and data collection have not started. CONCLUSIONS To our knowledge, this is the first study to evaluate the effectiveness of yoga and aerobic dance as pain management interventions for female adolescents with JIA. The use of online programs to disseminate these 2 PA interventions may facilitate access to alternative methods of pain management. This study can lead to a full-scale RCT. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/12823

scholarly journals Mindfulness-Based Program Plus Amygdala and Insula Retraining (MAIR) for the Treatment of Women with Fibromyalgia: A Pilot Randomized Controlled Trial

2020 ◽  
Vol 9 (10) ◽  
pp. 3246
Author(s):  
Juan P. Sanabria-Mazo ◽  
Jesus Montero-Marin ◽  
Albert Feliu-Soler ◽  
Virginia Gasión ◽  
Mayte Navarro-Gil ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Post Treatment ◽  
Effect Sizes ◽  
Control Group ◽  
Active Control Group ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

The lack of highly effective treatments for fibromyalgia (FM) represents a great challenge for public health. The objective of this parallel, pilot randomized controlled trial (RCT) was two-fold: (1) to analyze the clinical effects of mindfulness plus amygdala and insula retraining (MAIR) compared to a structurally equivalent active control group of relaxation therapy (RT) in the treatment of FM; and (2) to evaluate its impact on immune-inflammatory markers and brain-derived neurotrophic factor (BDNF) in serum. A total of 41 FM patients were randomized into two study arms: MAIR (intervention group) and RT (active control group), both as add-ons of treatment as usual. MAIR demonstrated significantly greater reductions in functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion at post-treatment and follow-up, with moderate to large effect sizes. Significant decreases in pain catastrophizing and psychological inflexibility and improvements in clinical severity and health-related quality of life were found at follow-up, but not at post-treatment, showing large effect sizes. The number needed to treat was three based on the criteria of ≥50% Fibromyalgia Impact Questionnaire (FIQ) reduction post-treatment. Compared to RT, the MAIR showed significant decreases in BDNF. No effect of MAIR was observed in immune-inflammatory biomarkers (i.e., TNF-α, IL-6, IL-10, and hs-CRP). In conclusion, these results suggest that MAIR, as an adjuvant of treatment-as-usual (TAU), appears to be effective for the management of FM symptoms and for reducing BDNF levels in serum.

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 Differential Diagnosis Assessment in Ambulatory Care With an Automated Medical History–Taking Device: Pilot Randomized Controlled Trial

10.2196/14044 ◽  
2019 ◽  
Vol 7 (4) ◽  
pp. e14044 ◽  
Author(s):  
Adrien Jean-Pierre Schwitzguebel ◽  
Clarisse Jeckelmann ◽  
Roberto Gavinio ◽  
Cécile Levallois ◽  
Charles Benaïm ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Differential Diagnosis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Differential Diagnoses ◽  
Control Group ◽  
History Taking ◽  
Randomized Controlled ◽  
Diagnosis Accuracy ◽  
Pilot Randomized Controlled Trial

Background Automated medical history–taking devices (AMHTDs) are emerging tools with the potential to increase the quality of medical consultations by providing physicians with an exhaustive, high-quality, standardized anamnesis and differential diagnosis. Objective This study aimed to assess the effectiveness of an AMHTD to obtain an accurate differential diagnosis in an outpatient service. Methods We conducted a pilot randomized controlled trial involving 59 patients presenting to an emergency outpatient unit and suffering from various conditions affecting the limbs, the back, and the chest wall. Resident physicians were randomized into 2 groups, one assisted by the AMHTD and one without access to the device. For each patient, physicians were asked to establish an exhaustive differential diagnosis based on the anamnesis and clinical examination. In the intervention group, residents read the AMHTD report before performing the anamnesis. In both the groups, a senior physician had to establish a differential diagnosis, considered as the gold standard, independent of the resident’s opinion and AMHTD report. Results A total of 29 patients were included in the intervention group and 30 in the control group. Differential diagnosis accuracy was higher in the intervention group (mean 75%, SD 26%) than in the control group (mean 59%, SD 31%; P=.01). Subgroup analysis showed a between-group difference of 3% (83% [17/21]-80% [14/17]) for low complexity cases (1-2 differential diagnoses possible) in favor of the AMHTD (P=.76), 31% (87% [13/15]-56% [18/33]) for intermediate complexity (3 differential diagnoses; P=.02), and 24% (63% [34/54]-39% [14/35]) for high complexity (4-5 differential diagnoses; P=.08). Physicians in the intervention group (mean 4.3, SD 2) had more years of clinical practice compared with the control group (mean 5.5, SD 2; P=.03). Differential diagnosis accuracy was negatively correlated to case complexity (r=0.41; P=.001) and the residents’ years of practice (r=0.04; P=.72). The AMHTD was able to determine 73% (SD 30%) of correct differential diagnoses. Patient satisfaction was good (4.3/5), and 26 of 29 patients (90%) considered that they were able to accurately describe their symptomatology. In 8 of 29 cases (28%), residents considered that the AMHTD helped to establish the differential diagnosis. Conclusions The AMHTD allowed physicians to make more accurate differential diagnoses, particularly in complex cases. This could be explained not only by the ability of the AMHTD to make the right diagnoses, but also by the exhaustive anamnesis provided.

scholarly journals Effect of Physician-Pharmacist Participation in the Management of Ambulatory Cancer Pain Through a Digital Health Platform: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Lu Zhang ◽  
Howard L McLeod ◽  
Ke-Ke Liu ◽  
Wen-Hui Liu ◽  
Hang-Xing Huang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Pain Management ◽  
Cancer Pain ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Management ◽  
Control Group ◽  
Randomized Controlled ◽  
Pain Scores

BACKGROUND Self-management of ambulatory cancer pain is full of challenges. Motivated by the need for better pain management, we developed a WeChat-supported platform, Medication Housekeeper (MediHK), to enhance communication, optimize outcomes, and promote self-management in the home setting. OBJECTIVE We conducted a randomized controlled trial to assess whether the joint physician-pharmacist team through MediHK would provide better self-management of ambulatory patients with cancer pain. METHODS Patients were randomly assigned to either an intervention group or control group. During the 4-week study period, the pharmacist would send 24-hour pain diaries daily, adverse drug reaction (ADR) forms every 3 days, and the Brief Pain Inventory form every 15 days to patients in the intervention group via MediHK. If a patient needed a change in drug/dosage or treatment of an ADR after the comprehensive review, the pharmacist would propose pharmacological interventions to the attending physician, who was then responsible for prescribing or adjusting pain medications. If no adjustments were needed, the pharmacist provided appropriate targeted education based on knowledge deficits. Patients in the control group received conventional care and did not receive reminders to fill out the forms. However, if the control group patients filled out a form via MediHK, the pain management team would review and respond in the same way as for the intervention group. The primary outcomes included pain intensity and pain interference in daily life. Secondary outcomes included patient-reported outcome measures, medication adherence, ADRs, and rehospitalization rates. RESULTS A total of 100 patients were included, with 51 (51%) in the intervention group and 49 (49%) in the control group. The worst pain scores, least pain scores, and average pain scores in the intervention group and the control group were statistically different, with median values of 4 (IQR 3-7) vs 7 (IQR 6-8; <i>P</i>=.001), 1 (IQR 0-2) vs 2 (IQR 1-3; <i>P</i>=.02), and 2 (IQR 2-4) vs 4 (IQR 3-5; <i>P</i>=.001), respectively, at the end of the study. The pain interference on patients' general activity, mood, relationships with others, and interests was reduced, but the difference was not statistically significant compared with the control group (<i>Ps</i>=.10-.76). The medication adherence rate increased from 43% to 63% in the intervention group, compared with an increase of 33% to 51% in the control group (<i>P</i>&lt;.001). The overall number of ADRs increased at 4 weeks, and more ADRs were monitored in the intervention group (<i>P</i>=.003). Rehospitalization rates were similar between the 2 groups. CONCLUSIONS The joint physician-pharmacist team operating through MediHK improved pain management. This study supports the feasibility of integrating the internet into the self-management of cancer pain. CLINICALTRIAL Chinese Clinical Trial Registry ChiCTR1900023075; https://www.chictr.org.cn/showproj.aspx?proj=36901

scholarly journals Text Messaging Adherence Intervention for Adolescents and Young Adults with Chronic Kidney Disease: Pilot Randomized Controlled Trial and Stakeholder Interviews (Preprint)

2020 ◽  
Author(s):  
Cyd Eaton ◽  
Margaret Comer ◽  
Cozumel Pruette ◽  
Kevin Psoter ◽  
Kristin Riekert
Keyword(s):  
Randomized Controlled Trial ◽  
Young Adults ◽  
Medication Adherence ◽  
Active Control ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Significant Group ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

BACKGROUND Up to one-third of adolescents and young adults (11-21 years old) with chronic kidney disease exhibit suboptimal rates of adherence to renal-protective antihypertensive medications. Mobile health interventions may promote higher adherence to these medicines in these individuals, but empirical research is needed to inform best practices for applying these modalities. OBJECTIVE In this multiphase investigation, we developed and tested a theoretically informed text messaging intervention based on the COM-B model, a well-established health intervention framework stating that capability, opportunity, and motivation interactively modify health behaviors, to improve participants’ antihypertensive medication adherence in a pilot randomized controlled trial. Qualitative data on user experiences were obtained. METHODS In phase 1, intervention messages (Reminder+COM-B Message) were developed via stakeholder engagement of participants and pediatric nephrologists. In phase 2, the Reminder+COM-B Message intervention was tested against a Reminder-only Message active control condition in an 8-week pilot randomized controlled trial. The primary outcome was daily electronically monitored antihypertensive medication adherence and secondary outcomes included pre-post participant surveys of adherence self-efficacy, adherence barriers, outcome expectancies for taking medicine, and motivation for and importance of taking medicine. In phase 3, qualitative interviews related to user experiences were conducted with participants in the Reminder+COM-B Message intervention group. RESULTS Following phase 1, 34 participants (mean age 16.59 years, 41% female, 38% African American/Black, 35% hypertension diagnosis) completed the phase 2 pilot randomized controlled trial (n=18 in the Reminder+COM-B Message intervention group, n=16 in the Reminder-only Message active control group). All participants in the Reminder+COM-B Message intervention group completed a phase 3 qualitative interview. Overall, study procedures were feasible and the Reminder+COM-B Message intervention was acceptable to the participants (eg, 15/18 participants reported reading the majority of messages sent to them, 0/18 reported that the messages reduced their desire to take medicine). Prerandomization, there were no significant group differences in the rate of change in daily adherence over time. However, postrandomization, there was a significant group by time interaction (B=.01, <i>P</i>=.04) in which daily adherence decreased significantly over time in the Reminder-only Message active control group but remained stable in the Reminder+COM-B Message intervention group. There were no significant differences between groups in pre-post changes in survey responses. Qualitative interviews revealed participants’ perceptions of how the Reminder+COM-B Message intervention changed adherence behavior and highlighted several areas for improving the intervention (eg, adapt messaging timing, intensity, and content to match daily adherence, send praise when medicine is taken). CONCLUSIONS The Reminder+COM-B Message intervention was feasible and acceptable to adolescents/young adults and demonstrated potential to promote participants’ daily medication adherence beyond simple reminders. Further research is needed to determine the Reminder+COM-B Message intervention’s mechanisms of adherence behavior change and to incorporate qualitative participant feedback into a modified version of this intervention to enhance its acceptability. CLINICALTRIAL ClinicalTrials.gov NCT03651596; https://clinicaltrials.gov/ct2/show/NCT03651596

scholarly journals Text Messaging Adherence Intervention for Adolescents and Young Adults with Chronic Kidney Disease: Pilot Randomized Controlled Trial and Stakeholder Interviews

10.2196/19861 ◽  
2020 ◽  
Vol 22 (8) ◽  
pp. e19861
Author(s):  
Cyd Eaton ◽  
Margaret Comer ◽  
Cozumel Pruette ◽  
Kevin Psoter ◽  
Kristin Riekert
Keyword(s):  
Randomized Controlled Trial ◽  
Young Adults ◽  
Medication Adherence ◽  
Active Control ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Significant Group ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Background Up to one-third of adolescents and young adults (11-21 years old) with chronic kidney disease exhibit suboptimal rates of adherence to renal-protective antihypertensive medications. Mobile health interventions may promote higher adherence to these medicines in these individuals, but empirical research is needed to inform best practices for applying these modalities. Objective In this multiphase investigation, we developed and tested a theoretically informed text messaging intervention based on the COM-B model, a well-established health intervention framework stating that capability, opportunity, and motivation interactively modify health behaviors, to improve participants’ antihypertensive medication adherence in a pilot randomized controlled trial. Qualitative data on user experiences were obtained. Methods In phase 1, intervention messages (Reminder+COM-B Message) were developed via stakeholder engagement of participants and pediatric nephrologists. In phase 2, the Reminder+COM-B Message intervention was tested against a Reminder-only Message active control condition in an 8-week pilot randomized controlled trial. The primary outcome was daily electronically monitored antihypertensive medication adherence and secondary outcomes included pre-post participant surveys of adherence self-efficacy, adherence barriers, outcome expectancies for taking medicine, and motivation for and importance of taking medicine. In phase 3, qualitative interviews related to user experiences were conducted with participants in the Reminder+COM-B Message intervention group. Results Following phase 1, 34 participants (mean age 16.59 years, 41% female, 38% African American/Black, 35% hypertension diagnosis) completed the phase 2 pilot randomized controlled trial (n=18 in the Reminder+COM-B Message intervention group, n=16 in the Reminder-only Message active control group). All participants in the Reminder+COM-B Message intervention group completed a phase 3 qualitative interview. Overall, study procedures were feasible and the Reminder+COM-B Message intervention was acceptable to the participants (eg, 15/18 participants reported reading the majority of messages sent to them, 0/18 reported that the messages reduced their desire to take medicine). Prerandomization, there were no significant group differences in the rate of change in daily adherence over time. However, postrandomization, there was a significant group by time interaction (B=.01, P=.04) in which daily adherence decreased significantly over time in the Reminder-only Message active control group but remained stable in the Reminder+COM-B Message intervention group. There were no significant differences between groups in pre-post changes in survey responses. Qualitative interviews revealed participants’ perceptions of how the Reminder+COM-B Message intervention changed adherence behavior and highlighted several areas for improving the intervention (eg, adapt messaging timing, intensity, and content to match daily adherence, send praise when medicine is taken). Conclusions The Reminder+COM-B Message intervention was feasible and acceptable to adolescents/young adults and demonstrated potential to promote participants’ daily medication adherence beyond simple reminders. Further research is needed to determine the Reminder+COM-B Message intervention’s mechanisms of adherence behavior change and to incorporate qualitative participant feedback into a modified version of this intervention to enhance its acceptability. Trial Registration ClinicalTrials.gov NCT03651596; https://clinicaltrials.gov/ct2/show/NCT03651596

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 1032 Auricular Point Acupressure for Sleep Disturbance in Women With Breast Cancer: A Pilot Randomized Controlled Trial

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A392-A392
Author(s):  
Y Wang ◽  
J Wu ◽  
J Li ◽  
J Zhou
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Sleep Disturbance ◽  
Controlled Trial ◽  
Control Group ◽  
Sleep Onset Latency ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Auricular Point ◽  
Pilot Randomized Controlled Trial

Abstract Introduction Sleep disturbance is reported in up to 60% of cancer patient. In traditional Chinese medicine, evidence suggests that auricular point acupressure (APA) improves sleep. However, little is known about APA’s effect on sleep disturbance in patients with breast cancer (BC). We tested the preliminary efficacy of APA on sleep in BC women undergoing chemotherapy. Methods A pilot randomized controlled trial was conducted in 41 BC patients (mean age=50±14) with self-reported poor sleep [Pittsburgh Sleep Quality Index (PSQI)≥7]. Participants were randomly assigned to an APA group (n=22) and a control group (n=19). All patients received sleep hygiene education. Additionally, for the APA group, magnetic pellets were attached to selected auricular points once a week for 3 weeks at the clinic, and the participants were instructed to self-press the pellets 4 times a day. Sleep were objectively measured by Actiwatch Spectrum and subjectively using PSQI at baseline and post-intervention. Paired t-tests and analyses of covariance using the variable baseline values were used to examine changes in sleep parameters. Results Twenty-one participants from the APA and sixteen from the control groups completed the study. Within the APA group, PSQI [mean difference (MD)=3.85, 95% Confidence Interval (C)=3.12~4.60] and sleep onset latency (MD=18.02, 95%CI=5.96~30.09) were significantly decreased, and the sleep duration (MD=-0.53, 95%CI=-0.99~-2.35) and sleep efficacy (MD=-5.00, 95%CI=-8.72~-1.28) were significant increased at post-intervention. Compared to the control group, participants in the APA group had significantly lower PSQI (F=30.77, p&lt;0.001) and greater sleep efficacy (F=5.25, p=0.028) at post-intervention. Conclusion APA may be an inexpensive and effective approach to improve sleep in patients with BC. More rigorous research with larger samples is needed to further test the efficacy of APA on promoting sleep in BC patients. Support None

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