Abstract WP315: A 3 Month Follow-up Of A Client-centred Activity Of Daily Living Intervention After Stroke: A Multicenter Randomized Controlled Trial

Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Maria Ranner ◽  
Ann-Sofie Bertilsson ◽  
Susanne Guidetti ◽  
Ulla Johansson ◽  
Gunilla Eriksson ◽  
...  
Keyword(s):  
Health Care ◽  
Life Satisfaction ◽  
Daily Living ◽  
Controlled Trial ◽  
Significance Level ◽  
Intention To Treat ◽  
Swedish Health Care ◽  
Multicenter Randomized Controlled Trial ◽  
Need To Evaluate ◽  
Rehabilitation Needs

A goal for rehabilitation after stroke is to regain the ability to manage activities of daily living (ADL). The Swedish health care legislation recognizes that individuals bring unique sets of needs and preferences to encounters with the health care system, which should impact the services delivered. Consequently rehabilitation needs to be designed to meet each individual’s concern i.e., be client-centered. This implies interventions tailored to the client’s ability and perceived needs, services that take the client’s unique life-world experiences as the point of departure for goals and collaboration during the rehabilitation. However, studies on such services are scarce. Thus the aim was to compare a client-centered ADL intervention (CADL) to usual ADL training (UADL) regarding perceived participation, independence in ADL and life satisfaction at 3 months after inclusion. Methods: Sixteen rehabilitation units in Stockholm, Uppsala and Gävleborg, Sweden were randomly assigned to deliver either CADL or UADL to people in need of ADL rehabilitation after stroke. The occupational therapists (OT) who delivered the CADL were specifically trained. At 3 months perceived participation was assessed with the Stroke impact scale (SIS) and the Occupational Gaps questionnaire (OGQ), self-reported dependence in ADL with the Barthel Index (BI) and the Katz Extended ADL Index (KE), and life satisfaction with the LiSat-11. Number of contacts with an OT was collected in the clients’ medical records. Intention-to-treat analysis was applied. The significance level was set to 0.05. ClinicalTrials.gov identifier: NCT01417585 . Results: Two hundred and eighty persons with stroke were included (CADL n=126, UADL n=154). The mean number of OT sessions in the CADL was 19 and 14 in the UADL group. There were no differences regarding SIS (p=0.64), OGQ (p=0.15), BI (p=0.06), KE (p=0.78) or in LiSat-11 (p=0.77). Conclusion: Albeit people with stroke who receive CADL tend to be more independent in ADL at 3 months it is likely that differences in perceived participation and life satisfaction will not be present until later. Thus there is a need to evaluate such services in the long term, their impact on significant others and qualitative studies of the clients’ experiences.

Gemcitabine and cisplatin (GP) induction chemotherapy (IC) plus concurrent chemoradiotherapy (CCRT) versus CCRT alone in locoregionally advanced nasopharyngeal carcinoma (NPC): A phase 3, multicenter, randomized controlled trial.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6003-6003 ◽  
Author(s):  
Jun Ma ◽  
Yuan Zhang ◽  
Ying Sun ◽  
Fangyun Xie ◽  
Weihan Hu ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intensity Modulated Radiotherapy ◽  
Free Survival ◽  
Intention To Treat ◽  
Multicenter Randomized Controlled Trial ◽  
Common Grade ◽  
Grade 3 ◽  
To Receive ◽  
Treat Population

6003 Background: GP regimen has been established as the standard first-line treatment option for patients with recurrent/metastatic NPC. However, its efficacy in locoregionally advanced disease remains unclear. Methods: Patients with previously untreated, non-metastatic stage III-IVB (except T3-4N0M0, AJCC 7th) NPC, aged 18–64 years without severe comorbidities were eligible. They were randomly assigned (1:1) to receive GP IC (gemcitabine 1 g/m2on days 1 & 8, cisplatin 80 mg/m2 on day 1, q3w for 3 cycles) plus CCRT (cisplatin 100 mg/m2, q3w for 3 cycles, concurrently with intensity-modulated radiotherapy) or CCRT alone. The primary endpoint was failure-free survival (FFS). The calculated sample size was 238 per group, with an 80% power (two-sided α 0.05) to detect a treatment failure hazard ratio (HR) of 0.52. Results: From Dec 2013 to Sep 2016, 480 patients from 12 centers were randomly assigned to IC+CCRT (n = 242) or CCRT alone (n = 238) group. Baseline characteristics were well balanced. After a median follow-up of 39 months, 3-year FFS was 85.8% in the IC+CCRT group and 77.2% in the CCRT alone group (intention-to-treat population; HR 0.53, 95% confidence interval 0.34–0.81; P = 0.003). In GP+CCRT group, 239 patients started GP IC and 231 (96.7%) completed all three cycles. The most common ≥grade 3 adverse events (AE) in IC+CCRT and CCRT group were mucositis (28.9% vs. 32.1%), neutropenia (28.0% vs. 10.5%) and leukopenia (26.4% vs. 20.3%). Conclusions: Adding GP IC to CCRT significantly improved FFS in locoregionally advanced NPC and is well tolerated with favorable toxicity profile. Clinical trial information: NCT01872962. [Table: see text]

First results of a phase III multicenter randomized controlled trial of intensity modulated (IMRT) versus conventional radiotherapy (RT) in head and neck cancer (PARSPORT: ISRCTN48243537; CRUK/03/005)

2009 ◽  
Vol 27 (18_suppl) ◽  
pp. LBA6006-LBA6006 ◽  
Author(s):  
C. Nutting ◽  
R. A'Hern ◽  
M. S. Rogers ◽  
M. A. Sydenham ◽  
F. Adab ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Controlled Trial ◽  
Late Toxicity ◽  
Primary Treatment ◽  
Phase Iii ◽  
Significance Level ◽  
Multicenter Randomized Controlled Trial ◽  
Secondary Endpoints

LBA6006 Background: Xerostomia is the most common late toxicity of RT to the head and neck. IMRT dose distributions reduce the dose delivered to parotid gland. PARSPORT investigated the role of IMRT in reducing xerostomia in patients with head and neck cancer. Methods: The PARSPORT trial compared two radiotherapy delivery methods in the treatment of patients with pharyngeal tumors (T1–4, N0–3, M0). Patients received 65Gy in 30 fractions over 6 weeks delivered using either CT planned parallel opposed lateral fields or parotid-sparing IMRT. Stratification was by site of tumor and center. The primary endpoint was incidence of LENT-SOMA ≥G2 xerostomia one year after treatment. Secondary endpoints included acute toxicities (CTCAE v3) and other late RTOG and LENT-SOMA radiation toxicities. Proportions of patients with ≥G2 toxicity were compared using exact tests. For secondary endpoints a significance level of 1% was used. Results: 94 patients (47 RT; 47 IMRT) were randomized between 2003 and 2007 from six UK centers. 80 patients had oropharyngeal tumors and 14 hypopharyngeal. Radiotherapy was given as primary treatment in 71 patients and post-operatively in 23. 22 patients had AJCC stage I/II disease. Median follow-up was 31.9 months (IQR: 26.6 –38.8). Twelve month LENT-SOMA ≥G2 xerostomia scores were observed in 74% (25/34) of RT and 40% (15/38) of IMRT patients (p=0.005). Corresponding values at 18 months were 71% (15/21) and 29% (9/31) (p=0.004). On the RTOG scale, 12 month ≥G2 xerostomia was reported in 64% (21/33) RT vs 41% (15/37) IMRT patients (p=0.06). The 18 month incidence was 81% 17/21 RT vs 20% (6/30) IMRT (p<0.001). Acute radiotherapy related ≥G2 fatigue was more prevalent in the IMRT group (76% vs 41% p=0.001). No differences in acute mucositis or pain scores were seen. At 12 months, no statistically significant differences were seen in other late toxicities. No differences were observed between overall survival and locoregional control rates. Conclusions: Sparing the salivary glands through use of IMRT significantly reduces the incidence of xerostomia in patients with pharyngeal tumors. [Table: see text]

scholarly journals N-ACETYLCYSTEINE AND/OR URSODEOXYCHOLIC ACID ASSOCIATED WITH METFORMIN IN NON-ALCOHOLIC STEATOHEPATITIS: AN OPEN-LABEL MULTICENTER RANDOMIZED CONTROLLED TRIAL

2019 ◽  
Vol 56 (2) ◽  
pp. 184-190 ◽  
Author(s):  
Claudia P OLIVEIRA ◽  
Helma P COTRIM ◽  
Jose Tadeu STEFANO ◽  
Ana Cristina G SIQUEIRA ◽  
Ana Lucia Azevedo SALGADO ◽  
...  
Keyword(s):  
Liver Disease ◽  
Ursodeoxycholic Acid ◽  
Clinical Laboratory ◽  
Controlled Trial ◽  
Open Label ◽  
Alcoholic Fatty Liver ◽  
Intention To Treat ◽  
Alcoholic Steatohepatitis ◽  
Multicenter Randomized Controlled Trial ◽  
Liver Biopsies

ABSTRACT BACKGROUND: Nowadays, pharmacological treatment of non-alcoholic fatty liver disease (NAFLD) is still limited and it is based on the treatment of conditions associated comorbities. Oxidative stress and insulin resistance are the mechanisms that seem to be mostly involved in its pathogenesis. OBJECTIVE: To evaluate the efficacy of N-acetylcysteine (NAC) in combination with metformin (MTF) and/or ursodeoxycholic acid (UDCA) for treatment of non-alcoholic steatohepatitis (NASH). METHODS: Open-label multicenter randomized trial was conducted for 48 weeks. It included patients with biopsy-proven NASH. The patients were randomized into three groups: NAC (1.2 g) + UDCA (15 mg/kg) + MTF (850-1500 mg/day) (n=26); UDCA (20 mg/kg) + MTF (850-1500 mg/day) (n=13); NAC (1.2g) + MTF (850-1500 mg/day) (n=14) for 48 weeks. Clinical, laboratory and the second liver biopsies were performed after 48 weeks. RESULTS: A total of 53 patients were evaluated; 17 (32.1%) were males; median age ±54 (IQR=15, 21-71) years. In the baseline, no difference was seen between groups according clinical and histological parameters. The groups differed only in cholesterol, LDL and triglycerides. No significant differences in biochemical and histologic parameters were found between these the three groups after 48 weeks of treatment. In the intragroup analysis (intention-to-treat) comparing histological and biochemical features, there were significant improvements in the steatosis degree (P=0.014), ballooning (0.027) and, consequently, in the NAFLD Activity Score (NAS) (P=0.005), and in the ALT levels at the end of the treatment only in the NAC + MTF group. No significant evidence of modification in the liver fibrosis could be observed in any of the groups. CONCLUSION: This multicenter study suggests that the association of NAC + MTF could reduce the liver disease activity in patients with NASH. These data stimulate further controlled studies with this therapy for these patients.

scholarly journals A digital health intervention for cardiovascular disease management in primary care (CONNECT) randomized controlled trial

2020 ◽  
Vol 3 (1) ◽  
Author(s):  
Julie Redfern ◽  
Genevieve Coorey ◽  
John Mulley ◽  
Anish Scaria ◽  
Lis Neubeck ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Primary Care ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Risk Factor ◽  
Digital Health ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

Abstract Digital health applications (apps) have the potential to improve health behaviors and outcomes. We aimed to examine the effectiveness of a consumer web-based app linked to primary care electronic health records (EHRs). CONNECT was a multicenter randomized controlled trial involving patients with or at risk of cardiovascular disease (CVD) recruited from primary care (Clinical Trial registration ACTRN12613000715774). Intervention participants received an interactive app which was pre-populated and refreshed with EHR risk factor data, diagnoses and, medications. Interactive risk calculators, motivational messages and lifestyle goal tracking were also included. Control group received usual health care. Primary outcome was adherence to guideline-recommended medications (≥80% of days covered for blood pressure (BP) and statin medications). Secondary outcomes included attainment of risk factor targets and eHealth literacy. In total, 934 patients were recruited; mean age 67.6 (±8.1) years. At 12 months, the proportion with >80% days covered with recommended medicines was low overall and there was no difference between the groups (32.8% vs. 29.9%; relative risk [RR] 1.07 [95% CI, 0.88–1.20] p = 0.49). There was borderline improvement in the proportion meeting BP and LDL targets in intervention vs. control (17.1% vs. 12.1% RR 1.40 [95% CI, 0.97–2.03] p = 0.07). The intervention was associated with increased attainment of physical activity targets (87.0% intervention vs. 79.7% control, p = 0.02) and e-health literacy scores (72.6% intervention vs. 64.0% control, p = 0.02). In conclusion, a consumer app integrated with primary health care EHRs was not effective in increasing medication adherence. Borderline improvements in risk factors and modest behavior changes were observed.

scholarly journals Infantile Spasms and Epilepsy Currents

2005 ◽  
Vol 5 (4) ◽  
pp. 157-158 ◽  
Author(s):  
Elinor Ben-Menachem
Keyword(s):  
United Kingdom ◽  
Adverse Events ◽  
Controlled Trial ◽  
Oral Prednisolone ◽  
Infantile Spasms ◽  
High Morbidity ◽  
Intention To Treat ◽  
The United Kingdom ◽  
Multicenter Randomized Controlled Trial ◽  
Hormonal Treatments

The United Kingdom Infantile Spasms Study Comparing Vigabatrin with Prednisolone or Tetracosactide at 14 Days: A Multicentre, Randomised Controlled Trial Lux AL, Edwards SW, Hancock E, Johnson AL, Kennedy CR, Newton RW, O'Callaghan FJ, Verity CM, Osborne JP Lancet 2004;364:1773–1778 Purpose Infantile spasms, a severe infantile seizure disorder, have a high morbidity and are difficult to treat. Hormonal treatments (adrenocorticotropic hormone and prednisolone) have been the main therapy for decades, although little evidence supports their use. Vigabatrin has been recorded to have a beneficial effect in this disorder. We aimed to compare the effects of vigabatrin with those of prednisolone and tetracosactide in the treatment of infantile spasms. Methods The United Kingdom Infantile Spasms Study assessed these treatments in a multicenter, randomized controlled trial in 150 hospitals in the United Kingdom. The primary outcome was cessation of spasms on days 13 and 14. Minimum doses were vigabatrin, 100 mg/kg/day; oral prednisolone, 40 mg/day; or intramuscular tetracosactide depot, 0.5 mg (40 IU) on alternate days. Analysis was by intention to treat. Results Of 208 infants screened and assessed, 107 were randomly assigned to vigabatrin ( n = 52) or hormonal treatments (prednisolone, n = 30; tetracosactide, n = 25). None was lost to follow-up. Proportions with no spasms on days 13 and 14 were 40 (73%) of 55 infants assigned hormonal treatments (prednisolone, 21 of 30 [70%]; tetracosactide, 19 of 25 [76%]) and 28 (54%) of 52 infants assigned vigabatrin (difference, 19%; 95% CI, 1%–36%, p = 0.043). Two infants allocated tetracosactide and one allocated vigabatrin received prednisolone. Adverse events were reported in 30 (55%) of 55 infants receiving hormonal treatments and 28 (54%) of 52 infants receiving vigabatrin. No deaths were recorded. Conclusions Cessation of spasms was more likely in infants given hormonal treatments than in those given vigabatrin. Adverse events were common with both treatments.

scholarly journals Auricular acupressure for adverse events following immunization related to COVID-19 vaccine injection: study protocol for a multicenter, three-arm, blinded randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Qinwei Fu ◽  
Hui Xie ◽  
Li Zhou ◽  
Xinrong Li ◽  
Yang Liu ◽  
...  
Keyword(s):  
Adverse Events ◽  
Preventive Intervention ◽  
Controlled Trial ◽  
Clinical Trial Registry ◽  
Significance Level ◽  
Intention To Treat ◽  
Medical Institutions ◽  
Auricular Acupressure ◽  
Potential Association ◽  
Gastrointestinal Adverse Events

Abstract Background Some pain, fatigue, and gastrointestinal adverse events were observed in potential association with injection of COVID-19 vaccines, while there was no preventive intervention for it. We aim to investigate the efficacy of auricular acupressure (AA) therapy in preventing and relieving AEFI after injection of COVID-19 vaccine. Methods The study design is a randomized, multicentre, three-arm controlled, single-blind trial. Participants meeting the inclusion criteria will be advertised and enrolled and assigned in the medical institutions randomly for post-injection observation. No less than 360 participants will be randomized into one of three groups: auricular acupressure group, sham auricular acupressure group, and wait-list group. Interventions will be performed immediately and will happen 4 to 5 times per day for 5 days. The primary clinical outcomes will be quality and quantity evaluation among participants who reported any AEFI and who reported local pain at injection site. Secondary outcomes will concern headache, muscle and (or) joint pain, fatigue, nausea, vomiting, diarrhoea, and other potential events. All the outcomes will be assessed at baseline and 1, 3, 5, 7, and 14 days after the injection. Both intention-to-treat and per-protocol analyses will be performed, with significance level determined as 5%. Discussion Results of this trial will help to clarify the value of auricular acupressure therapy in preventing and relieving overall and certain adverse events following immunization after injection of COVID-19 vaccine. Trial registration China Clinical Trial Registry (ChiCTR) (ChiCTR2100043210). Registered on 8 February, 2021.

scholarly journals Assessment of 5-Year Outcomes of Life Satisfaction in Acute Respiratory Distress Syndrome Survivors After Rehabilitation Programs: A Prospective, Multicenter, Randomized Controlled Trial

2021 ◽  
Author(s):  
Farshid Rahimi-Bashar ◽  
Mahmood Salesi ◽  
Keivan Gohari-Moghadam ◽  
Mohamad Amin Pourhoseingholi ◽  
Amir Vahedian_Azimi
Keyword(s):  
Life Satisfaction ◽  
Acute Respiratory Distress Syndrome ◽  
Pulmonary Function ◽  
Respiratory Distress Syndrome ◽  
Respiratory Distress ◽  
Distress Syndrome ◽  
Controlled Trial ◽  
Control Group ◽  
Multicenter Randomized Controlled Trial ◽  
Empowerment Model

Abstract The use of rehabilitation program for survivors of Acute Respiratory Distress Syndrome (ARDS) could be one of the important and fundamental steps to improve the pulmonary function and health related quality of life (HRQoL) of patients. This study was carried out to evaluate the effect of two rehabilitation techniques (Family-Based Empowerment Model (FECM)/Continuing Care Model (CCM), or both of them) on pulmonary function and HRQoL in ARDS survivor. From December 2009 to October 2014, ARDS survivors from mixed medical-surgical ICUs at four academic teaching hospitals in Tehran, Iran, randomly assigned to one of three intervention groups (A, B or C) or a control group (D). Pre- and post-interventions, pulmonary functions and HRQoL status of patients in all groups were collected 48 times through clinical measurements and various questionnaires during 5 years of follow-up. Significantly improvement was seen in the intervention groups compared to the control group, and the greatest benefit was observed in patients that received mixed of FCEM and CCM rehabilitation techniques. Co-administration of FCEM and CCM can improve pulmonary function as well as the life satisfaction of ARDS survivors. As a result, the execution of the empowerment model by nurses is recommended for ARDS survivors and the participation of their families at the same time. Trial registration: NCT02787720 (ClinicalTrial.gov, 01/06/2016).

scholarly journals A Single Intra-Articular Injection of Gel-200 for Treatment of Symptomatic Osteoarthritis of the Knee Is More Effective than Phosphate Buffered Saline at 6 Months: A Subgroup Analysis of a Multicenter, Randomized Controlled Trial

Cartilage ◽  
2018 ◽  
Vol 10 (4) ◽  
pp. 417-422 ◽  
Author(s):  
Junko Takamura ◽  
Takayuki Seo ◽  
Vibeke Strand
Keyword(s):  
Randomized Controlled Trial ◽  
Subgroup Analysis ◽  
Controlled Trial ◽  
Group Differences ◽  
Osteoarthritis Of The Knee ◽  
Womac Pain ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Phosphate Buffered Saline

Objective Many clinical trials of viscosupplementation have been conducted, although only the Gel-200 (primary) trial included a different patient population. A subgroup analysis of a multicenter, randomized controlled trial comparing the efficacy of single intra-articular injections of Gel-200 with phosphate buffered saline (PBS) was performed to demonstrate its benefit as treatment of osteoarthritis of the knee in a population similar to those of other reported trials of viscosupplementation. Design The subgroup population was defined as patients in the intention-to-treat (ITT) population who met the specified criteria. Changes from baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores following treatment with Gel-200 or PBS were derived from a longitudinal model and treatment differences compared between groups at weeks 12 and 26, and over 26 weeks. Results The subgroup included 311 subjects (152 Gel-200; 159 PBS). Mean improvements from baseline in WOMAC pain subscores in the Gel-200 over PBS groups were statistically significant at week 12 ( P = 0.031) and week 26 ( P = 0.019). Treatment group differences in WOMAC stiffness and total scores were statistically significant at week 26 ( P = 0.023 and P = 0.036, respectively). Conclusions The efficacy of Gel-200 following a single injection for knee osteoarthritis was demonstrated in WOMAC pain, stiffness, and total scores as well as clinically important improvements in pain at 26 weeks in this subset of patients with comparable characteristics to populations evaluated in other viscosupplementation treatment trials.

scholarly journals Effects of a 16-week multimodal exercise program on activities of daily living in institutionalized individuals with dementia

2021 ◽  
Author(s):  
Jelena Bezold ◽  
Sandra Trautwein ◽  
Bettina Barisch-Fritz ◽  
Andrea Scharpf ◽  
Janina Krell-Roesch ◽  
...  
Keyword(s):  
Activities Of Daily Living ◽  
Daily Living ◽  
Motor Performance ◽  
Performance Test ◽  
Controlled Trial ◽  
Exercise Program ◽  
Repeated Measurements ◽  
Individual Response ◽  
Multicenter Randomized Controlled Trial ◽  
Adl Performance

AbstractWe aimed to examine the effects of a 16-week multimodal exercise program (MEP) on activities of daily living (ADL) in individuals with dementia (IWD). Furthermore, we investigated the participants’ individual response to the MEP and whether baseline cognitive and motor performance explain ADL performance. We conducted a multicenter randomized controlled trial (RCT) involving 319 participants aged ≥ 65 years with mild to moderate dementia. ADL were assessed at baseline and after the 16-week intervention using the Barthel Index (BI), the Erlangen Test of Activities of Daily Living (E-ADL) and the 7‑item Physical Performance Test (PPT-7). We additionally assessed cognitive and motor performance using standardized and validated assessments. Intervention effects were examined through two-factor analysis of variance with repeated measurements applying a per protocol and an intention-to-treat analysis. We compared baseline cognitive and motor performance between positive-responders (positive-R), non-responders (non-R), and negative-responders (negative-R) and examined cognitive and motor performance as potential cofounders of ADL by conducting multiple regression analyses. There were no significant time×group effects on ADL. Between 20 and 32% of participants responded positively to the intervention, i.e., improved ADL performance from baseline to follow-up. Positive-R had worse baseline motor performance compared to non-R. Cognitive and motor performance explained up to 51.4% of variance in ADL. The MEP had no significant overall effect on ADL in IWD. This may be related to insufficient exercise intensity. However, our results indicate that the response to the MEP depends on individual prerequisites which should thus be considered in further research on individual exercise approaches.

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