scholarly journals Maintenance cognitive stimulation therapy for dementia: single-blind, multicentre, pragmatic randomised controlled trial

2014 ◽  
Vol 204 (6) ◽  
pp. 454-461 ◽  
Author(s):  
Martin Orrell ◽  
Elisa Aguirre ◽  
Aimee Spector ◽  
Zoe Hoare ◽  
Robert T. Woods ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cognitive Stimulation ◽  
Cognitive Stimulation Therapy ◽  
People With Dementia ◽  
Randomised Controlled ◽  
Single Blind ◽  
Pragmatic Randomised Controlled Trial

BackgroundThere is good evidence for the benefits of short-term cognitive stimulation therapy for dementia but little is known about possible long-term effects.AimsTo evaluate the effectiveness of maintenance cognitive stimulation therapy (CST) for people with dementia in a single-blind, pragmatic randomised controlled trial including a substudy with participants taking acetylcholinesterase inhibitors (AChEIs).MethodThe participants were 236 people with dementia from 9 care homes and 9 community services. Prior to randomisation all participants received the 7-week, 14-session CST programme. The intervention group received the weekly maintenance CST group programme for 24 weeks. The control group received usual care. Primary outcomes were cognition and quality of life (clinical trial registration: ISRCTN26286067).ResultsFor the intervention group at the 6-month primary end-point there were significant benefits for self-rated quality of life (Quality of Life in Alzheimer's Disease (QoL-AD) P = 0.03). At 3 months there were improvements for proxy-rated quality of life (QoL-AD P = 0.01, Dementia Quality of Life scale (DEMQOL) P = 0.03) and activities of daily living (P = 0.04). The intervention subgroup taking AChEIs showed cognitive benefits (on the Mini-Mental State Examination) at 3 (P = 0.03) and 6 months (P = 0.03).ConclusionsContinuing CST improves quality of life; and improves cognition for those taking AChEIs.

scholarly journals Efficacy of an evidence-based cognitive stimulation therapy programme for people with dementia

2003 ◽  
Vol 183 (3) ◽  
pp. 248-254 ◽  
Author(s):  
Aimee Spector ◽  
Lene Thorgrimsen ◽  
Bob Woods ◽  
Lindsay Royan ◽  
Steve Davies ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Older People ◽  
Intervention Group ◽  
Cognitive Stimulation ◽  
Control Group ◽  
Cognitive Stimulation Therapy ◽  
People With Dementia

BackgroundA recent Cochrane review of reality orientation therapy identified the need for large, well-designed, multi-centre trials.AimsTo test the hypothesis that cognitive stimulation therapy (CST) for older people with dementia would benefit cognition and quality of life.MethodA single-blind, multi-centre, randomised controlled trial recruited 201 older people with dementia. The main outcome measures were change in cognitive function and quality of life. An intention-to-treat analysis used analysis of covariance to control for potential variability in baseline measures.ResultsOne hundred and fifteen people were randomised within centres to the intervention group and 86 to the control group. At follow-up the intervention group had significantly improved relative to the control group on the Mini-Mental State Examination (P=0.044), the Alzheimer's Disease Assessment Scale – Cognition (ADAS–Cog) (P=0.014) and Quality of Life – Alzheimer's Disease scales (P=0.028). Using criteria of 4 points or more improvement on the ADAS–Cog the number needed to treat was 6 for the intervention group.ConclusionThe results compare favourably with trials of drugs for dementia. CST groups may have worthwhile benefits for many people with dementia.

scholarly journals Individual cognitive stimulation therapy for people with intellectual disability and dementia: protocol of a feasibility randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e022136 ◽  
Author(s):  
Afia Ali ◽  
Emma Brown ◽  
Aimee Spector ◽  
Elisa Aguirre ◽  
Angela Hassiotis
Keyword(s):  
Quality Of Life ◽  
Intellectual Disability ◽  
Randomised Controlled Trial ◽  
Cognitive Decline ◽  
Controlled Trial ◽  
Cognitive Stimulation ◽  
Secondary Outcome ◽  
Cognitive Stimulation Therapy ◽  
Randomised Controlled

IntroductionCognitive stimulation therapy (CST) is a psychosocial intervention for dementia. Group CST is effective in reducing cognitive decline and improving quality of life in patients with dementia. There is some evidence that individual CST (iCST) may be beneficial in reducing cognitive decline. People with intellectual disability (ID) have an increased risk of dementia. However, there are no published studies of CST in people with ID and dementia. This protocol describes the feasibility and acceptability of a randomised controlled trial of iCST delivered by carers to people with ID and dementia, compared with treatment as usual (TAU). The results of this study will inform the design of a future definitive randomised controlled trial.Methods and analysisThe iCST intervention has been adapted for this trial. Forty dyads (individuals with ID and their carer) will be randomised to either iCST or TAU. The manualised intervention comprises 40 iCST sessions delivered by a carer for 30 min, twice a week, over 20 weeks. The primary outcome will be process measures assessing the feasibility and acceptability of the intervention and trial procedures. The secondary outcome will be changes in the scores of outcome measures (cognition, functional ability and quality of life in individuals with ID, and caregiver burden, competence in managing dementia, and anxiety and depression in carers). Data will be collected at baseline, 11 weeks and at 21 weeks. A process evaluation will examine adherence to iCST and will include qualitative interviews with participants to identify aspects of the intervention that were or were not successful.Ethics and disseminationThe study has received ethical approval. The results of the study will be presented at conferences and submitted to a peer reviewed journal.Trial registration numberISRCTN18312288; Pre-results.

scholarly journals Estimating the minimum important difference in the DEMQOL instrument in people with dementia

2021 ◽  
Author(s):  
Ellen C. Lee ◽  
Jessica Wright ◽  
Stephen J. Walters ◽  
Cindy L. Cooper ◽  
Gail A. Mountain
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Minimum Important Difference ◽  
Absolute Change ◽  
People With Dementia ◽  
Related Quality ◽  
Registration Number ◽  
Clinically Significant ◽  
Randomised Controlled

Abstract Purpose The Dementia-Related Quality of Life (DEMQOL) measure and the DEMQOL-Utility Score (DEMQOL-U) are validated tools for measuring quality of life (QOL) in people with dementia. What score changes translate to a clinically significant impact on patients’ lives was unknown. This study establishes the minimal important differences (MID) for these two instruments. Methods Anchor-based and distribution-based methods were used to estimate the MID scores from patients enrolled in a randomised controlled trial. For the anchor-based method, the global QOL (Q29) item from the DEMQOL was chosen as the anchor for DEMQOL and both Q29 and EQ-5D for DEMQOL-U. A one category difference in Q29, and a 0.07 point difference in EQ-5D score, were used to classify improvement and deterioration, and the MID scores were calculated for each category. These results were compared with scores obtained by the distribution-based methods. Results A total of 490 people with dementia had baseline DEMQOL data, of these 386 had 8-month data, and 344 had 12-month DEMQOL data. The absolute change in DEMQOL for a combined 1-point increase or decrease in the Q29 anchor was 5.2 at 8 months and 6.0 at 12 months. For the DEMQOL-U, the average absolute change at 8 and 12 months was 0.032 and 0.046 for the Q29 anchor and 0.020 and 0.024 for EQ-5D anchor. Conclusion We present MID scores for the DEMQOL and DEMQOL-U instruments obtained from a large cohort of patients with dementia. An anchored-based estimate of the MID for the DEMQOL is around 5 to 6 points; and 0.02 to 0.05 points for the DEMQOL-U. The results of this study can guide clinicians and researchers in the interpretation of these instruments comparisons between groups or within groups of people with dementia. Trial Registration Number and date of registration: ISRCTN17993825 on 11th October 2016.

scholarly journals Pilot Randomised Evaluation of Singing in Dementia (PRESIDE): protocol for a two-arm, parallel-group randomised controlled feasibility study with waiting-list control

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Becky Dowson ◽  
Justine Schneider ◽  
Boliang Guo ◽  
Philip M. Bath ◽  
Orii McDermott ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Waiting List ◽  
Community Group ◽  
People With Dementia ◽  
Parallel Group ◽  
Randomised Controlled ◽  
Person With Dementia

Abstract Background As the number of people living with dementia grows, so does the need to provide them with adequate psychosocial support. Many people with dementia live at home with family carers, who also require social and emotional support to cope with their role. Community group singing has received attention for its potential to support people with dementia and their carers. It is postulated that singing can improve cognitive function, strengthen the bonds between care partners and help to establish social support networks. However, there is a lack of rigorous evidence of singing’s benefits for this population. This study aims to test the feasibility of a randomised controlled trial of community singing in dementia, to pave the way for a larger, conclusive study. Methods The PRESIDE study is designed as a two-arm, parallel-group randomised trial with a waiting list control. Dyads consisting of a person with dementia (n = 80) and their carer (n = 80) will be recruited. Each dyad will be randomised either to attend 10 weeks of community group singing sessions straight away or to wait for 3 months before attending the sessions. The singing sessions will be led by experienced professional musicians and will last about 90 min, including time for socialising. The primary outcome of this study is the attainment of feasibility criteria around recruitment, retention and the acceptability of the waiting list control. Secondary outcomes include the quality of life, mood, cognition, and musical engagement of the person with dementia, and quality of life, mood, and experiences/challenges of the carer. These data will be collected during home visits at baseline, and 3 and 6 months post-baseline. Discussion Despite growing public interest in the positive effects of singing, and encouraging findings from qualitative and non-randomised quantitative studies, there is a lack of rigorous evidence. This is the first randomised controlled trial of community group singing for people with dementia in Europe, to our knowledge. If the results favour a full trial, conclusively demonstrating the effectiveness of group singing could positively affect the opportunities available to community-dwelling people with dementia and their carers. Trial registration Unique identification number in ISRCTN registry: ISRCTN10201482. Date registered: 12 May 2020

Hysteroscopic management of a uterine caesarean scar defect (niche) in women with postmenstrual spotting: a randomised controlled trial

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Hatem Hussein El-Gamal ◽  
Walid El-Basuony Mohammad ◽  
Ahmed Samir Mohamed Zeerban
Keyword(s):  
Quality Of Life ◽  
Caesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Expectant Management ◽  
Control Group ◽  
Randomised Controlled ◽  
Caesarean Scar Defect ◽  
Interventional Group

Abstract Background Long-term complaints after caesarean section, such as postmenstrual spotting, dysmenorrhea, dyspareunia, or chronic pelvic pain, are frequently described in relation to the presence of a niche. A post-caesarean niche is defined as an indentation in the myometrium at the site of the uterine scar. Two independent prospective cohort studies reported that the presence of a niche after caesarean section increases the risk of postmenstrual spotting for more than 2 days from 15 to 30%. Postmenstrual spotting may be caused by a mechanical outflow problem, with the retention of menstrual blood in a niche, or by the accumulation of blood because of impaired uterine contractions at the site of the niche. Additionally, newly formed fragile vessels in the niche may play a role in the formation of blood or fluid in the niche and uterine cavity. Objective The aim of this study was to compare the effectiveness of a hysteroscopic niche resection versus no treatment in women with postmenstrual spotting and a uterine caesarean scar defect. Methods This trial is a randomised controlled trial that provides evidence for the (cost) effectiveness of hysteroscopic resection of a niche versus expectant management in women with niche related postmenstrual spotting. It was carried out on 28 cases divided into two equal group. The study was conducted at Ain Shams University on the women reporting postmenstrual spotting after a caesarean section. The primary outcome was the number of days of postmenstrual spotting 6 months after randomization. Secondary outcomes were spotting at the end of menstruation, intermenstrual spotting, dysuria, sonographic niche measurements, quality of life, women’s satisfaction, sexual function, and additional therapy. Outcomes were measured at 3 months and, also at 6 months after randomization. Results The results of this study show a significant improvement in interventional group after 3 months more than the control group in bleeding micturition characteristics which includes total days of spotting, spotting end of menstruation, intermenstral spotting, discomfort from spotting, dysmenorrhea and daily pain during micturition, after 6 months the two group improved but the interventional group was significantly higher than control group. Regarding the radiological assessment it was found that there was a significant improvement in intervention group more than the control group after 3 months, also the control group improved after 6 months also, but the intervention groups was significantly higher than the control group. The quality of life show a significant increasing in intervention group more than the control group after 3 months of intervention, at the end of follow up the intervention group was significantly higher in quality of life more than the control group. Conclusion A hysteroscopic niche resection reduces postmenstrual spotting, and the discomfort from spotting, compared with expectant management after 3 months of follow-up in women with a niche with a residual myometrium of at least 3 mm.

scholarly journals Stress Management in Elementary School Students: a Pilot Randomised Controlled Trial

2021 ◽  
Vol 26 (1) ◽  
pp. e976
Author(s):  
Katerina Sofianopoulou ◽  
Flora Bacopoulou ◽  
Dimitrios Vlachakis ◽  
Ioulia Kokka ◽  
Evaggelos Alexopoulos ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Elementary School ◽  
Randomised Controlled Trial ◽  
Elementary School Students ◽  
Controlled Trial ◽  
Intervention Group ◽  
School Students ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled

Research has shown that stress experiences begin in early stages of life. Stress management techniques have appeared to be beneficial for the development or enhancement of stress coping skills. The aim of this pilot randomised controlled trial was to assess the effect of a 12-week intervention, comprising training in diaphragmatic breathing and progressive muscular relaxation, on elementary school students’ stress levels. Outcomes on the quality of life and behavioural aspects of the students were also assessed. Standardised questionnaires were administered at baseline and after the 12-week intervention program. Fifty-two children aged 10 to 11 years were randomly assigned to intervention (n=24) and control groups (n=28). Children of the intervention group demonstrated lower levels of stress (in all three subscales of lack of well-being, distress, and lack of social support) and improved aspects of quality of life (physical, emotional, and school functioning). No significant differences were observed regarding the examined behavioural dimensions, in the intervention group. Larger randomised controlled trials with follow-up evaluations are needed to ascertain the positive outcomes of such programs on elementary school children.

Inspiratory muscle training does not improve clinical outcomes in 3-week COPD rehabilitation: results from a randomised controlled trial

2018 ◽  
Vol 51 (1) ◽  
pp. 1702000 ◽  
Author(s):  
Konrad Schultz ◽  
Danijel Jelusic ◽  
Michael Wittmann ◽  
Benjamin Krämer ◽  
Veronika Huber ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pulmonary Rehabilitation ◽  
Controlled Trial ◽  
Intervention Group ◽  
Inspiratory Muscle ◽  
Inspiratory Muscle Training ◽  
Chronic Obstructive ◽  
Muscle Training ◽  
Randomised Controlled

The value of inspiratory muscle training (IMT) in pulmonary rehabilitation in chronic obstructive pulmonary disease (COPD) is unclear. The RIMTCORE (Routine Inspiratory Muscle Training within COPD Rehabilitation) randomised controlled trial examined the effectiveness of IMT added to pulmonary rehabilitation.In total, 611 COPD patients (Global Initiative for Chronic Obstructive Lung Disease stage II–IV) received a 3-week inpatient pulmonary rehabilitation, of which 602 patients were included in the intention-to-treat analyses. The intervention group (n=300) received highly intensive IMT and the control group (n=302) received sham IMT. The primary outcome was maximal inspiratory pressure (PImax). The secondary outcomes were 6-min walk distance, dyspnoea, quality of life and lung function. Outcomes were assessed pre- and post-pulmonary rehabilitation. ANCOVA was used.The intervention group showed higher effects in PImax (p<0.001) and forced inspiratory volume in 1 s (p=0.013). All other outcomes in both study groups improved significantly, but without further between-group differences. Sex and pulmonary rehabilitation admission shortly after hospitalisation modified quality of life effects.IMT as an add-on to a 3-week pulmonary rehabilitation improves inspiratory muscle strength, but does not provide additional benefits in terms of exercise capacity, quality of life or dyspnoea. A general recommendation for COPD patients to add IMT to a 3-week pulmonary rehabilitation cannot be made.

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