A randomized prospective open-label controlled trial comparing the performance of a connected monitoring interface versus physical routine monitoring in patients with rheumatoid arthritis

Rheumatology ◽  
2020 ◽  
Author(s):  
Yves-Marie Pers ◽  
Verushka Valsecchi ◽  
Thibault Mura ◽  
Safa Aouinti ◽  
Nathalie Filippi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Disease Activity ◽  
Short Form ◽  
Controlled Trial ◽  
Routine Practice ◽  
Tight Control ◽  
Open Label ◽  
Functional Scores ◽  
Monitoring Group

Abstract Objectives In RA, telemedicine may allow tight control of disease activity while reducing hospital visits. We developed a smartphone application connected with a physician’s interface to monitor RA patients. We aimed to assess the performance of this e-Health solution in comparison with routine practice in the management of patients with RA. Methods A six-month pragmatic, randomized, controlled, prospective, clinical trial was conducted in RA patients with high to moderate disease activity starting a new DMARD therapy. Two groups were established: ‘connected monitoring’ and ‘conventional monitoring’. The primary outcome was the number of physical visits between baseline and six months. Secondary outcomes included adherence, satisfaction, changes in clinical, functional and health status scores (Short-Form 12). Results Of the 94 randomized patients, 89 completed study: 44 in the ‘conventional monitoring’ arm and 45 in the ‘connected monitoring’ arm. The total number of physical visits between required baseline and six-month visits was significantly lower in the ‘connected monitoring’ group [0.42 (0.58) vs 1.93 (0.55); P <0.05]. No differences between groups were observed in the clinical and functional scores. A better quality of life for Short-Form 12 subscores (Role-Physical and Role-Emotional) were found in the ‘connected monitoring’ group. Conclusion Our results suggest that connected monitoring reduces the number of physical visits while maintaining a tight control of disease activity and improving quality of life in patients with RA starting a new treatment. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov, NCT03005925.

scholarly journals FRI0651-HPR A RANDOMIZED PROSPECTIVE OPEN-LABEL CONTROLLED TRIAL COMPARING THE PERFORMANCE OF A CONNECTED MONITORING INTERFACE IN PATIENTS WITH RHEUMATOID ARTHRITIS VERSUS PHYSICAL ROUTINE MONITORING

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 929.1-930
Author(s):  
Y. M. Pers ◽  
V. Valsecchi ◽  
T. Mura ◽  
S. Aouinti ◽  
N. Filippi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Rheumatic Diseases ◽  
Tight Control ◽  
Link Type ◽  
Functional Scores ◽  
Monitoring Group ◽  
Disease Modifying

Background:Telemedicine has found wider application in chronic diseases for encouraging tight home-monitoring in order to improve patients’ outcome (Smolen et al. 2017).In previous studies, a high feasibility and high patient-satisfaction rate was found as well as the evidence for a superior or equal effectiveness of telemedicine compared to the standard face-to-face approach, however the results were weakened by some methodological biases and wide heterogeneity of interventions, thus preventing to draw definitive conclusions (Piga et al. 2017; Najm, Gossec, et al. 2019).Objectives:In rheumatoid arthritis (RA), telemedicine may allow a tight control of disease activity while reducing hospital visits. We developed a smartphone application connected with a physician’s interface to monitor RA patients. We aimed to assess the performance of this e-Health solution in comparison with routine practice in the management of patients with RA.Methods:A 6-month pragmatic, randomized, controlled, prospective, clinical trial was conducted in RA patients with high to moderate disease activity starting a new Disease Modifying Anti-Rheumatic Drug (DMARD) therapy. Two groups were established: “connected monitoring” and “conventional monitoring”. The primary outcome was the number of physical visits between baseline and 6 months. Secondary outcomes included adherence, satisfaction, changes in clinical, functional, and health status scores (SF-12).Results:Of the 94 randomized patients, 89 completed study: 44 in the “conventional monitoring” arm and 45 in the “connected monitoring” arm. The total number of physical visits between baseline and 6 month was significantly lower in the “connected monitoring” group (0.42 ± 0.58 versus 1.93 ± 0.55; p<0.05). No differences between groups were observed in the clinical and functional scores. A better quality of life for SF-12 subscores (Role-Physical, Social-Functioning and Role-Emotional) were found in the “connected monitoring” group.Conclusion:According to our results, a connected monitoring reduces the number of physical visits while maintaining a tight control of disease activity and improving quality of life in patients with RA starting a new treatment.References:[1] Najm, Aurelie, Laure Gossec, Catherine Weill, David Benoist, Francis Berenbaum, and Elena Nikiphorou. 2019. “Mobile Health Apps for Self-Management of Rheumatic and Musculoskeletal Diseases: Systematic Literature Review.”JMIR MHealth and UHealth7 (11): e14730.https://doi.org/10.2196/14730.[2] Piga, Matteo, Ignazio Cangemi, Alessandro Mathieu, and Alberto Cauli. 2017. “Telemedicine for Patients with Rheumatic Diseases: Systematic Review and Proposal for Research Agenda.”Seminars in Arthritis and Rheumatism47 (1): 121–28.https://doi.org/10.1016/j.semarthrit.2017.03.014.[3] Smolen, Josef S, Robert Landewe, Johannes Bijlsma, Gerd Burmester, Katerina Chatzidionysiou, Maxime Dougados, Jackie Nam, et al. 2017. “EULAR Recommendations for the Management of Rheumatoid Arthritis with Synthetic and Biological Disease-Modifying Antirheumatic Drugs: 2016 Update.”Annals of the Rheumatic Diseases76 (6): 960–77.https://doi.org/10.1136/annrheumdis-2016-210715.Disclosure of Interests:None declared

The Therapeutic Effects of Acupuncture on Patients with Chronic Neck Myofascial Pain Syndrome: A Single-Blind Randomized Controlled Trial

2010 ◽  
Vol 38 (05) ◽  
pp. 849-859 ◽  
Author(s):  
Mei-Yuan Sun ◽  
Ching-Liang Hsieh ◽  
Yung-Yen Cheng ◽  
Hung-Chang Hung ◽  
Tsai-Chung Li ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Myofascial Pain ◽  
Short Form ◽  
Controlled Trial ◽  
Pain Syndrome ◽  
Myofascial Pain Syndrome ◽  
Randomized Controlled ◽  
Single Blind

Chronic neck myofascial pain syndrome (MPS) is a common disorder seen in clinics. There is no gold standard method to treat myofascial pain. We investigated the effects of acupuncture on patients with chronic neck MPS by a single-blind randomized controlled trial. A total of 35 patients were randomly allocated to an acupuncture group (AG) or a sham acupuncture group (SG). Each subject received acupuncture treatment twice per week for three consecutive weeks. The primary outcome measure was quality of life as assessed with Short Form-36, and secondary outcome measures were neck range of motion (ROM), motion-related pain, and Short-Form McGill Pain Questionnaire (SF-MPQ), as determined by a blinded investigator. The clinical assessments were made before treatment (BT) and after six acupuncture treatments (AT), as well as four weeks (F1) and 12 weeks (F2) after the end of the treatment. A total of 34 patients completed the trial. The results indicated that there is no significant difference in the ROM, motion-related pain, and SF-MPQ scores between AG and SG at AT, F1 and F2 (all p > 0.05). However, AG has greater improvement in physical functioning and role emotional of Short Form-36 quality of life at F2. The results indicate that acupuncture may be used to improve the quality of life in patients with chronic neck MPS.

An Open-Label, Analgesic Efficacy and Safety of Pituitary Radiosurgery for Patients With Opioid-Refractory Pain: Study Protocol for a Randomized Controlled Trial

Neurosurgery ◽  
2017 ◽  
Vol 83 (1) ◽  
pp. 146-153 ◽  
Author(s):  
Pierre-Yves Borius ◽  
Stéphanie Ranque Garnier ◽  
Karine Baumstarck ◽  
Frédéric Castinetti ◽  
Anne Donnet ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pain Relief ◽  
Cancer Pain ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Standards Of Care ◽  
Control Group ◽  
Efficacy And Safety ◽  
Open Label

Abstract BACKGROUND Hypophysectomy performed by craniotomy or percutaneous techniques leads to complete pain relief in more than 70% to 80% of cases for opioid refractory cancer pain. Radiosurgery could be an interesting alternative approach to reduce complications. OBJECTIVE To assess the analgesic efficacy compared with standard of care is the primary goal. The secondary objectives are to assess ophthalmic and endocrine tolerance, drug consumption, quality of life, and mechanisms of analgesic action. METHODS The trial is multicenter, randomized, prospective, and open-label with 2 parallel groups. This concerns patients in palliative care suffering from nociceptive or mixed cancer pain, refractory to standard opioid therapy. Participants will be randomly assigned to the control group receiving standards of care for pain according to recommendations, or to the experimental group receiving a pituitary GammaKnife (Elekta, Stockholm, Sweden) radiosurgery (160 Gy delivered in pituitary gland) associated with standards of care. Evaluation assessments will be taken at baseline, day0, day4, day7, day14, day28, day45, month3, and month6. EXPECTED OUTCOMES We could expect pain improvement in 70% to 90% of cases at day4. In addition we will assess the safety of pituitary radiosurgery in a vulnerable population. The secondary endpoints could show decay of opioid consumption, good patient satisfaction, and improvement of the quality of life. DISCUSSION The design of this study is potentially the most appropriate to demonstrate the efficacy and safety of radiosurgery for this new indication. New recommendations could be obtained in order to improve pain relief and quality of life.

Outcomes

2013 ◽  
pp. 221-226
Author(s):  
David L. Scott
Keyword(s):  
Quality Of Life ◽  
Disease Activity ◽  
Short Form ◽  
Organ Damage ◽  
Confounding Factors ◽  
Short Term ◽  
Self Assessment ◽  
The Matrix ◽  
The Impact

Outcomes evaluate the impact of disease. In rheumatology they span measures of disease activity, end-organ damage, and quality of life. Some outcomes are categorical, such as the presence or absence of remission. Other outcomes involve extended numeric scales such as joint counts, radiographic scores, and quality of life measures. Outcomes can be measured in the short term—weeks and months—or over years and decades. Short-term outcomes, though readily related to treatment, may have less relevance for patients. Clinical trials focus on short-term outcomes whereas observational studies explore longer-term outcomes. The matrix of rheumatic disease outcomes is exemplified by rheumatoid arthritis. Its outcomes span disease activity assessments like joint counts, damage assessed by erosive scores, quality of life evaluated by disease-specific measures like the Health Assessment Questionnaire (HAQ) or generic measures like the Short Form 36 (SF-36), overall assessments like remission, and end result such as joint replacement or death. Outcome measures capture the impact of treating rheumatic diseases. They are influenced by disease severity and effective treatment. They also reflect many confounding factors. These include demographic factors like age, gender, and ethnicity and also deprivation, as poverty worsens outcomes. Comorbidities affect outcomes and patients with multiple comorbid conditions have worse quality of life with poorer outcomes. Patient self-assessment has grown in importance; it is simple and understandable. However, self-assessment can vary over time and does not always reflect assessors’ perspectives. Caution is needed comparing outcomes across units; the various confounding factors and measurement complexities make such comparative analyses challenging.

scholarly journals Time in remission and low disease activity state (LDAS) are associated with a better quality of life in patients with systemic lupus erythematosus: results from LUMINA (LXXIX), a multiethnic, multicentre US cohort

RMD Open ◽  
2019 ◽  
Vol 5 (1) ◽  
pp. e000955 ◽  
Author(s):  
Manuel Francisco Ugarte-Gil ◽  
Guillermo J Pons-Estel ◽  
Luis M Vila ◽  
Gerald McGwin ◽  
Graciela S Alarcón
Keyword(s):  
Quality Of Life ◽  
Systemic Lupus Erythematosus ◽  
Disease Activity ◽  
Lupus Erythematosus ◽  
Short Form ◽  
Systemic Lupus ◽  
Low Disease Activity ◽  
Sf 36 ◽  
Activity State

AimsTo determine whether the proportion of time systemic lupus erythematosus patients achieve remission/low disease activity state (LDAS) is associated with a better quality of life (QoL).Patients and methodsPatients from a well-established multiethnic, multicentre US cohort were included: remission: Systemic Lupus Activity Measure (SLAM) score=0, prednisone≤5 mg/day and no immunosuppressants); LDAS not in remission, SLAM score≤3, prednisone≤7.5 mg/day, no immunosuppressants; the combined proportion of time patients were in these states was the independent variable. The endpoints were the Physical and Mental Components Summary measures (PCS and MCS, respectively) and the individual subscales of the Short Form (SF)-36 at the last visit. Linear regression was used to estimate the association between the proportion of follow-up time in remission/LDAS and the SF-36 measures with and without adjustment for possible confounders.ResultsFour hundred and eighty-three patients were included. The per cent of time on remission/LDAS was associated with better QoL after adjusting for potential confounders; for the PCS the parameter estimate was 9.47 (p<0.0001), for the MCS 5.89 (p=0.0027), and for the subscales they ranged between 7.51 (p=0.0495) for mental health and 31.79 (p<0.0001) for role physical.ConclusionsThe per cent of time lupus patients stay on remission/LDAS is associated with a better QoL as measured by SF-36.

scholarly journals Effect of probiotics on nasal and intestinal microbiota in people with high exposure to particulate matter ≤ 2.5 μm (PM2.5): a randomized, double-blind, placebo-controlled clinical study

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Yongcan Wu ◽  
Caixia Pei ◽  
Xiaomin Wang ◽  
Mingjie Wang ◽  
Demei Huang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Intestinal Microbiota ◽  
Rating Scale ◽  
Short Form ◽  
Controlled Trial ◽  
High Exposure ◽  
Gastrointestinal Symptom Rating Scale ◽  
Probiotic Treatment ◽  
High Concentrations

Abstract Background Extended exposure to high concentrations of PM2.5 changes the human microbiota profile, which in turn may increase morbidity and mortality due to respiratory system damage. A balanced microecosystem is crucial to human health, and certain health-related problems may be addressed by effective microecosystem regulation. Recent studies have confirmed that probiotics may reduce the incidence of respiratory diseases. However, few studies have investigated probiotic treatment outcomes in subjects exposed to high concentrations of PM2.5. Methods This study is designed as a prospective, randomized, participants- and assessor-blinded, placebo-controlled trial. One hundred and twenty eligible volunteers recruited from October 2019 to July 2020 in downtown Chengdu, China, will be treated with either probiotics or placebo over 4 consecutive weeks. The primary outcome will be 16SrRNA sequencing assay data from nasal and intestinal secretions. Secondary outcomes will be pulmonary function, score on a gastrointestinal symptom rating scale, COOP/WONCA charts, and the Short-Form Health Survey 36 for quality of life. Results will be analyzed to assess differences in clinical efficacy between groups. Six-month follow-up examinations will evaluate the long-term value of probiotics on cardiovascular and respiratory disease end-point events. Discussion We will explore the characteristics of nasal and intestinal microbiota in a population with high exposure to PM2.5. Probiotics and placebo interventions will be tested for efficacy in microbial balance regulation, effects on lung and physical functions, and quality of life improvement. This study is expected to provide reliable evidence to support the widespread promotion of probiotics in clinical practice for the protection of individuals with high exposure to PM2.5. Trial registration Chinese Clinical Trial Registry ChiCTR1900025469. Registered on 27 August 2019.

scholarly journals “VelaMente?!” - Sailin in a Crew to Improve Self-Efficacy in People with Psychosocial Disabilities: A Randomized Controlled Trial

2017 ◽  
Vol 13 (1) ◽  
pp. 200-212 ◽  
Author(s):  
Federica Sancassiani ◽  
Alessio Cocco ◽  
Giulia Cossu ◽  
Stefano Lorrai ◽  
Giuseppina Trincas ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Sense Of Coherence ◽  
Self Efficacy ◽  
Longitudinal Research ◽  
Short Form ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Waiting List ◽  
Treatment As Usual

Introduction:It has been proposed that sailing can improve quality of life, personal and social skills of people with severe psychosocial disabilities. This study aimed to assess the efficacy of a psychosocial rehabilitative intervention focused on sailing on quality of life, self-efficacy and sense of coherence in people with severe psychosocial disabilities.Methods:The study was a randomized, with parallel groups, waiting-list controlled trial. Participants were 51 people with severe psychosocial disabilities. The intervention was a structured course to learn sailing in a crew lasting three months. A randomized group began the sailing course immediately after a pre-treatment assessment; the waitlist group began the sailing course after a three months period of treatments as usual. Participants were assessed before and after the sailing course, or the waiting list period, on the General Self-Efficacy scale (GSES), Sense Of Coherence scale (SOC) and Health Survey-short form (SF-12).Results:Self-efficacy significantly increased after the sailing course and decreased after treatment as usual (p=0.015). Sense of coherence and the levels of quality of life tended to improve after the sailing course, albeit below levels of statistical significance.Conclusion:When compared to more traditional psychosocial rehabilitative activities, an intervention focused on sailing in a crew positively impacts the sense of coherence and the levels of quality of life and significantly improves self-efficacy of people with severe psychosocial disabilities. Further longitudinal research is required.

scholarly journals Effects of a probiotic treatment (Enterococcus faecalis) and open-label placebo on symptoms of allergic rhinitis: study protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e031339 ◽  
Author(s):  
Michael Schaefer ◽  
Paul Enck
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Study Design ◽  
Controlled Trial ◽  
Life Questionnaire ◽  
Open Label ◽  
Quality Of Life Questionnaire ◽  
Probiotic Treatment ◽  
Randomised Controlled

IntroductionSeveral studies suggest that gut microbiota may play an important role in allergic diseases. The present trial aims to examine effects of the probioticEnterococcus faecalison symptoms of allergic rhinitis in patients. Effects of this probiotic on the immune system have been reported by several studies, but the majority of the previous trials were animal studies. In addition, it is well known that symptoms in allergic rhinitis are prone to exhibit high placebo responses. Moreover, recent studies report that even placebos without deception (open-label placebos) are highly effective in reducing symptoms of allergic rhinitis. Our study design combines both new approaches to assess effects on allergic symptoms in patients. The objective of this study is to compare the effects of a probiotic treatment (E. faecalis) with effects seen by open-label placebo, concealed placebo treatment and no treatment control.Methods and analysisA total of 120 patients with allergic rhinitis will be randomly assigned to one of four different groups: a double-blind probiotic/placebo group (groups 1 and 2), an open-label placebo group (group 3) and a no-treatment group (group 4) to control for spontaneous variation of symptoms. The primary outcome is the evaluation of allergic symptoms using the Combined Symptoms Medication Score. Furthermore, health-related quality of life is examined (Rhinitis Quality of Life Questionnaire). Secondary outcomes include a visual analogue scale on allergic burden and a second quality of life questionnaire. This report describes the study design of the randomised controlled trial.Ethics and disseminationThe study design was approved by the ethical committee of the UKT Department of Psychosomatic Medicine and Psychotherapy, Tübingen, Germany. The trial is registered at the German Clinical Trials Register (www.drks.de, DRKS00015804). The trial results will be published in peer-reviewed journals and at conferences.Trial registration numberGerman Clinical Trials Register (www.drks.de, DRKS00015804); Pre-results.

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