scholarly journals Can acupuncture combined with SSRIs improve clinical symptoms and quality of life in patients with depression? Secondary outcomes of a pragmatic randomized controlled trial

2019 ◽  
Vol 45 ◽  
pp. 295-302 ◽  
Author(s):  
Bingcong Zhao ◽  
Zhigang Li ◽  
Yuanzheng Wang ◽  
Xuehong Ma ◽  
Xiangqun Wang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Secondary Outcomes

Challenges of Telemonitoring Programs for Complex Chronic Conditions: A Randomized Controlled Trial with an Embedded Qualitative Study (Preprint)

2021 ◽  
Author(s):  
Patrick Ware ◽  
Amika Shah ◽  
Heather Joan Ross ◽  
Alexander Gordon Logan ◽  
Phillip Segal ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Decision Support ◽  
Chronic Conditions ◽  
Controlled Trial ◽  
Self Care ◽  
Randomized Controlled ◽  
Complex Patients ◽  
Secondary Outcomes

BACKGROUND Despite the growing prevalence of people with complex conditions and evidence of the positive impact of telemonitoring for single conditions, little research exists on the use of telemonitoring in this population, particularly those with multiple chronic conditions (MCCs). OBJECTIVE This randomized controlled trial (RCT) and embedded qualitative study aimed to evaluate the impact and experiences of patients and healthcare providers (HCPs) using a telemonitoring system with decision support to manage complex patients, including those with MCCs, compared to the standard of care. METHODS A pragmatic 6-month RCT sought to recruit 146 patients with a diagnosis of heart failure (HF), uncontrolled hypertension (HT), and/or insulin requiring diabetes (DM) from outpatient specialty settings in Toronto, Canada. Participants were randomized into the control and telemonitoring groups with the latter being instructed to take readings relevant to their condition(s). The telemonitoring system contained an algorithm that generated decision support in the form of actionable self-care directives to patients and alerts to HCPs. The primary outcome was health status as measured by the SF-36. Secondary outcomes included anxiety and depression, self-efficacy in chronic disease management, and self-reported healthcare utilization. HF-related quality of life and self-care measures were also collected from patients followed for HF. Within- and between-group change scores were analyzed for statistical significance (P<.05). A convenience sample of HCPs and patients in the intervention group were interviewed about their experiences RESULTS A total of 96 patients were recruited and randomized. Recruitment was terminated early due to implementation challenges and the onset of COVID-19. No significant within- and between-group differences were found for the main primary and secondary outcomes. However, a within-group analysis of HF patients found improvements in self-care maintenance (P=.036) and physical quality of life (P= .046). Opinions expressed by the 5 HCPs and 13 patients interviewed differed based on the condition(s) monitored. Although HF patients reported benefitting from actionable self-care guidance and meaningful interactions with their HCPs, patient and HCP users of the DM and HT modules did not think telemonitoring improved the clinical management of those conditions to the same degree. These differing experiences were largely attributed to the siloed nature of specialty care, and the design of the decision support whereby it was indicated that fluctuations in HT and DM patient status typically required less urgent intervention compared to HF. CONCLUSIONS Consistent with previous studies, we recommend that future research conceive telemonitoring as a program and that self-management and clinical decision support are necessary, but not sufficient components of such programs for complex patients with lower acuity. We conclude that a multidisciplinary model of care that includes care coordination must accompany telemonitoring systems which may best be operationalized through novel models of care, such as nurse-led models. CLINICALTRIAL ClinicalTrials.gov NCT03127852, ISRCTN (41238563) INTERNATIONAL REGISTERED REPORT RR2-10.2196/resprot.8367

Efficacy of task-specific circuit training on physical activity levels and mobility of stroke patients: A randomized controlled trial

2020 ◽  
Vol 47 (4) ◽  
pp. 451-462
Author(s):  
Júlia Caetano Martins ◽  
Sylvie Nadeau ◽  
Larissa Tavares Aguiar ◽  
Aline Alvim Scianni ◽  
Luci Fuscaldi Teixeira-Salmela ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Experimental Group

BACKGROUND: Impaired mobility is related to low physical activity (PA) levels observed after stroke. Therapeutic approaches, such as task-specific circuit training (TSCT), used to improve mobility in individuals with stroke, could also improve PA levels. OBJECTIVE: To investigate the efficacy of TSCT, focused on both upper (UL) and lower (LL) limbs, in improving PA levels and mobility (primary outcomes), as well as muscle strength, exercise capacity, and quality of life (secondary outcomes) in subjects with stroke. METHODS: A randomized controlled trial with 36 subjects with chronic stroke was conducted. Experimental group: TSCT, involving both UL and LL. Control group: global stretching, memory exercises, and education sessions. Both groups received 60 minute sessions/week over 12 weeks. Outcomes were measured at baseline, post-intervention and 16 week follow-up. RESULTS: No changes were found for primary and secondary outcomes (0.11≤p≤0.99), except for quality of life, which improved in the experimental group post-intervention and 16 week follow-up (p = 0.02). CONCLUSION: TSCT focused on both UL and LL was not effective on PA levels and mobility of individuals with chronic stroke, however, improvements in quality of life were observed. Since this is the first study to investigate this combined training aimed at improving PA levels, future studies are necessary to better understand the impact of this type of intervention.

scholarly journals Effect of Acupuncture on Lung Cancer-Related Fatigue: Study Protocol for a Multi-center Randomized Controlled Trial

2019 ◽  
Author(s):  
Zhaoqin Wang ◽  
Shanshan Li ◽  
Luyi Wu ◽  
Qin Qi ◽  
Huirong Liu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Acupuncture Treatment ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Cancer Related Fatigue ◽  
Secondary Outcomes

Abstract Background Fatigue is one of the primary symptoms of lung cancer patients, with a prevalence of 88.0% in cancer survivors, and even higher post resection surgery. Effective fatigue control after lung cancer surgery is important for patient recovery and quality of life. Some studies have shown that acupuncture might be effective in treating cancer-related fatigue, however, randomized controlled trials of suitable sample size are limited. Method/Design This is a multi-center, patient-blind, randomized controlled trial (RCT). A total of 320 eligible patients will be recruited in four centers (Shanghai Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai Chest Hospital and LongHua Hospital Shanghai University of Traditional Chinese Medicine) and randomly assigned to either the acupuncture group or the sham acupuncture group in a 1:1ratio. Treatment will be given twice per week for 12 sessions. Treatment will consist of acupoints GV20, GV29, CV12, CV6, CV4, and bilateral LI4, LR3, SP6, ST36. The primary outcome will be assessed using the Chinese version of Brief Fatigue Inventory-Chinese (BFI-C), the secondary outcomes will be measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), and Hamilton Rating Scale for Depression (HAMD). The primary outcome will be assessed at all main points (baseline, the 3rd week, the 6th week and follow-ups), the secondary outcomes will be assessed at baseline and the 6th week. Intention-to-treat (ITT) analysis will be used in this RCT. Discussion This trial protocol provides an example of clinical application for the management of lung cancer-related fatigue using acupuncture treatment. If the acupuncture treatment protocol confirms that acupuncture is an effective and safe option for lung cancer-related fatigue, it can be adopted as a standardized treatment.

scholarly journals The effects of acupuncture on the secondary outcomes of anxiety and quality of life for women undergoing IVF: A randomized controlled trial

2019 ◽  
Vol 98 (4) ◽  
pp. 460-469 ◽  
Author(s):  
Caroline A. Smith ◽  
Sheryl de Lacey ◽  
Michael Chapman ◽  
Julie Ratcliffe ◽  
Robert J. Norman ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Secondary Outcomes

scholarly journals Effect of Acupuncture on Lung Cancer-Related Fatigue: Study Protocol for a Multi-center Randomized Controlled Trial

2019 ◽  
Author(s):  
Zhaoqin Wang ◽  
Shanshan Li ◽  
Luyi Wu ◽  
Qin Qi ◽  
Huirong Liu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Acupuncture Treatment ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Cancer Related Fatigue ◽  
Secondary Outcomes

Abstract Background Fatigue is one of the primary symptoms of lung cancer patients, with a prevalence of 88.0% in cancer survivors, and even higher post resection surgery. Effective fatigue control after lung cancer surgery is important for patient recovery and quality of life. Some studies have shown that acupuncture might be effective in treating cancer-related fatigue, however, randomized controlled trials of suitable sample size are limited. Method/Design This is a multi-center, patient-blind, randomized controlled trial (RCT). A total of 320 eligible patients will be recruited in four centers (Shanghai Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai Chest Hospital and LongHua Hospital Shanghai University of Traditional Chinese Medicine) and randomly assigned to either the acupuncture group or the sham acupuncture group in a 1:1ratio. Treatment will be given twice per week for 12 sessions. Treatment will consist of acupoints GV20, GV29, CV12, CV6, CV4, and bilateral LI4, LR3, SP6, ST36. The primary outcome will be assessed using the Chinese version of Brief Fatigue Inventory-Chinese (BFI-C), the secondary outcomes will be measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), and Hamilton Rating Scale for Depression (HAMD). The primary outcome will be assessed at all main points (baseline, the 3rd week, the 6th week and follow-ups), the secondary outcomes will be assessed at baseline and the 6th week. Intention-to-treat (ITT) analysis will be used in this RCT. Discussion This trial protocol provides an example of clinical application for the management of lung cancer-related fatigue using acupuncture treatment. If the acupuncture treatment protocol confirms that acupuncture is an effective and safe option for lung cancer-related fatigue, it can be adopted as a standardized treatment.

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