scholarly journals Design and Development of the Brain Training System for the Digital “Maintain Your Brain” Dementia Prevention Trial (Preprint)

2019 ◽  
Author(s):  
Courtney Campbell Walton ◽  
Amit Lampit ◽  
Christos Boulamatsis ◽  
Harry Hallock ◽  
Polly Barr ◽  
...  
Keyword(s):  
Digital Health ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Cognitive Activity ◽  
Training System ◽  
Support Network ◽  
Brain Training ◽  
Design And Development ◽  
Main Trial ◽  
Comparative Feedback

BACKGROUND Dementia is the leading cause of disability worldwide, and interventions aimed at reducing the prevalence and burden of the disease are urgently needed. Maintain Your Brain (MYB) is a randomized controlled trial of a multimodal digital health intervention targeting modifiable dementia risk factors to combat cognitive decline and potentially prevent dementia. In addition to behavioral modules targeting mood, nutrition, and physical exercise, a new Brain Training System (BTS) will deliver computerized cognitive training (CCT) throughout the trial to provide systematic, challenging, and personally adaptive cognitive activity. OBJECTIVE This paper aimed to describe the design and development of BTS. METHODS BTS has been designed with a central focus on the end user. Raw training content is provided by our partner NeuroNation and delivered in several innovative ways. A baseline cognitive profile directs selection and sequencing of exercises within and between sessions and is updated during the 10-week 30-session module. Online trainers are available to provide supervision at different levels of engagement, including face-to-face share-screen coaching, a key implementation resource that is triaged by a “red flag” system for automatic tracking of user adherence and engagement, or through user-initiated help requests. Individualized and comparative feedback is provided to aid motivation and, for the first time, establish a social support network for the user based on their real-world circle of friends and family. RESULTS The MYB pilot was performed from November 2017 to March 2018. We are currently analyzing data from this pilot trial (n=100), which will make up a separate research paper. The main trial was launched in June 2018. Process and implementation data from the first training module (September to November 2018) are expected to be reported in 2019 and final trial outcomes are anticipated in 2022. CONCLUSIONS The BTS implemented in MYB is focused on maximizing adherence and engagement with CCT over the short and long term in the setting of a fully digital trial, which, if successful, could be delivered economically at scale. CLINICALTRIAL Australian New Zealand Clinical Trials Registry ACTRN12618000851268; https://www.anzctr.org.au /Trial/Registration/TrialReview.aspx?id=370631&isReview=true

scholarly journals Early Signs Monitoring to Prevent Relapse in Psychosis and Promote Well-Being, Engagement, and Recovery: Protocol for a Feasibility Cluster Randomized Controlled Trial Harnessing Mobile Phone Technology Blended With Peer Support

10.2196/15058 ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. e15058 ◽  
Author(s):  
Andrew Gumley ◽  
Simon Bradstreet ◽  
John Ainsworth ◽  
Stephanie Allan ◽  
Mario Alvarez-Jimenez ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Digital Health ◽  
Controlled Trial ◽  
Well Being ◽  
Service Users ◽  
Main Trial ◽  
Definitive Trial ◽  
Randomized Controlled ◽  
Cluster Randomized

Background Relapse in schizophrenia is a major cause of distress and disability and is predicted by changes in symptoms such as anxiety, depression, and suspiciousness (early warning signs [EWSs]). These can be used as the basis for timely interventions to prevent relapse. However, there is considerable uncertainty regarding the implementation of EWS interventions. Objective This study was designed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) against treatment as usual (TAU). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings. We will assess the feasibility of candidate primary outcomes, candidate secondary outcomes, and candidate mechanisms for a definitive trial. Methods We will randomize CMHSs to EMPOWER or TAU. We aim to recruit up to 120 service user participants from 8 CMHSs and follow them for 12 months. Eligible service users will (1) be aged 16 years and above, (2) be in contact with local CMHSs, (3) have either been admitted to a psychiatric inpatient service or received crisis intervention at least once in the previous 2 years for a relapse, and (4) have an International Classification of Diseases-10 diagnosis of a schizophrenia-related disorder. Service users will also be invited to nominate a carer to participate. We will identify the feasibility of the main trial in terms of recruitment and retention to the study and the acceptability, usability, safety, and outcome signals of the EMPOWER intervention. EMPOWER is a mobile phone app that enables the monitoring of well-being and possible EWSs of relapse on a daily basis. An algorithm calculates changes in well-being based on participants’ own baseline to enable tailoring of well-being messaging and clinical triage of possible EWSs. Use of the app is blended with ongoing peer support. Results Recruitment to the trial began September 2018, and follow-up of participants was completed in July 2019. Data collection is continuing. The database was locked in July 2019, followed by analysis and disclosing of group allocation. Conclusions The knowledge gained from the study will inform the design of a definitive trial including finalizing the delivery of our digital health intervention, sample size estimation, methods to ensure successful identification, consent, randomization, and follow-up of participants, and the primary and secondary outcomes. The trial will also inform the final health economic model to be applied in the main trial. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 99559262; http://isrctn.com/ISRCTN99559262 International Registered Report Identifier (IRRID) DERR1-10.2196/15058

scholarly journals Early Signs Monitoring to Prevent Relapse in Psychosis and Promote Well-Being, Engagement, and Recovery: Protocol for a Feasibility Cluster Randomized Controlled Trial Harnessing Mobile Phone Technology Blended With Peer Support (Preprint)

2019 ◽  
Author(s):  
Andrew Gumley ◽  
Simon Bradstreet ◽  
John Ainsworth ◽  
Stephanie Allan ◽  
Mario Alvarez-Jimenez ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Digital Health ◽  
Controlled Trial ◽  
Well Being ◽  
Service Users ◽  
Main Trial ◽  
Definitive Trial ◽  
Randomized Controlled ◽  
Cluster Randomized

BACKGROUND Relapse in schizophrenia is a major cause of distress and disability and is predicted by changes in symptoms such as anxiety, depression, and suspiciousness (early warning signs [EWSs]). These can be used as the basis for timely interventions to prevent relapse. However, there is considerable uncertainty regarding the implementation of EWS interventions. OBJECTIVE This study was designed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) against treatment as usual (TAU). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings. We will assess the feasibility of candidate primary outcomes, candidate secondary outcomes, and candidate mechanisms for a definitive trial. METHODS We will randomize CMHSs to EMPOWER or TAU. We aim to recruit up to 120 service user participants from 8 CMHSs and follow them for 12 months. Eligible service users will (1) be aged 16 years and above, (2) be in contact with local CMHSs, (3) have either been admitted to a psychiatric inpatient service or received crisis intervention at least once in the previous 2 years for a relapse, and (4) have an International Classification of Diseases-10 diagnosis of a schizophrenia-related disorder. Service users will also be invited to nominate a carer to participate. We will identify the feasibility of the main trial in terms of recruitment and retention to the study and the acceptability, usability, safety, and outcome signals of the EMPOWER intervention. EMPOWER is a mobile phone app that enables the monitoring of well-being and possible EWSs of relapse on a daily basis. An algorithm calculates changes in well-being based on participants’ own baseline to enable tailoring of well-being messaging and clinical triage of possible EWSs. Use of the app is blended with ongoing peer support. RESULTS Recruitment to the trial began September 2018, and follow-up of participants was completed in July 2019. Data collection is continuing. The database was locked in July 2019, followed by analysis and disclosing of group allocation. CONCLUSIONS The knowledge gained from the study will inform the design of a definitive trial including finalizing the delivery of our digital health intervention, sample size estimation, methods to ensure successful identification, consent, randomization, and follow-up of participants, and the primary and secondary outcomes. The trial will also inform the final health economic model to be applied in the main trial. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN): 99559262; http://isrctn.com/ISRCTN99559262

scholarly journals Design and Development of the Brain Training System for the Digital “Maintain Your Brain” Dementia Prevention Trial

JMIR Aging ◽  
10.2196/13135 ◽  
2019 ◽  
Vol 2 (1) ◽  
pp. e13135 ◽  
Author(s):  
Courtney Campbell Walton ◽  
Amit Lampit ◽  
Christos Boulamatsis ◽  
Harry Hallock ◽  
Polly Barr ◽  
...  
Keyword(s):  
Training System ◽  
Prevention Trial ◽  
Brain Training ◽  
Design And Development ◽  
Dementia Prevention ◽  
The Brain

Pilot, open non-controlled trial to assess the feasibility of implementing objective parameters as primary endpoints in a clinical trial with patients affected by knee osteoarthritis. (Preprint)

2019 ◽  
Author(s):  
Bogdan Corneliu Andor ◽  
Dionisio Franco Barattini ◽  
Dumitru Emanuel Dogaru ◽  
Simone Guadagna ◽  
Serban Rosu
Keyword(s):  
Chondroitin Sulphate ◽  
Controlled Trial ◽  
Subjective Evaluation ◽  
Pilot Trial ◽  
Final Visit ◽  
Life Questionnaire ◽  
Quality Of Data ◽  
Open Label ◽  
Objective Measurements

BACKGROUND Osteoarthritis (OA) is one of the top five most disabling conditions and it affects more than one third of persons over 65 years of age. Currently 80% of persons affected by OA already report having some movement limitation, 20% of people are not be able to perform major activities of daily living, and about 11% of the total affected population need of personal care. On 2014 the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) suggested as first step of pharmacological treatment for knee OA a background therapy with chronic symptomatic slow-acting drugs for osteoarthritis (SYSADOAs), such as glucosamine sulphate, chondroitin sulphate and hyaluronic acid (HA). In studies with oral HA, symptoms of OA are often measured using subjective parameters such as the visual analog scale (VAS) or the quality of life questionnaire (QoL) and objective measurements as ultrasonography (US) or range of motion (ROM) are employed in very few trials. This affects the quality of data in the literature. OBJECTIVE The primary objective of this work is to assess the feasibility of implementing US and ROM as objective measurements to correlate the improvement of knee mobility with pain reduction, evaluated using a subjective scale (VAS) in patients assuming a nutraceutical containing HA. The secondary objective is to evaluate the enrollment rate in one month to verify the feasibility for time and budget of the planned future main study. The explorative objective of the trial is to obtain preliminary data on efficacy of the tested product. METHODS This open-label pilot trial is performed in an orthopedic clinic (Timisoara, Romania). Male and female subjects (from 50 to 70 years) diagnosed with symptomatic OA of the knee with mild joint discomfort for at least 6 months are included. Following protocol, 8 patients are administered for 8 weeks Syalox® 300 Plus (River Pharma, Italy), a product based on HA of high molecular weight. Baseline and final visit assessments include orthopedic assessment, US, Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire, VAS and ROM of knee. RESULTS Data collection occurred between February 2018 and June 2018. All results are expected to be available by the end of 2018. CONCLUSIONS This pilot trial will be the first study to analyze the potential correlation between subjective evaluation (VAS, KOOS questionnaire) and objective measurements (US, ROM and actigraphy). The data from this study will assess the feasibility of the planned monthly recruitment rate and the necessary time and budget, and should provide preliminary information on efficacy of the tested product. CLINICALTRIAL ClinicalTrials.gov (NCT number: NCT03421054).

scholarly journals Metformin reduces 12-month change in body weight among people newly commenced on clozapine: a retrospective naturalistic cohort study

2021 ◽  
Vol 11 ◽  
pp. 204512532110006
Author(s):  
Jessica Spokes ◽  
Samantha Hollingworth ◽  
Karl Winckel ◽  
Steve Kisely ◽  
Andrea Baker ◽  
...  
Keyword(s):  
Cohort Study ◽  
Weight Gain ◽  
Tobacco Smoking ◽  
Digital Health ◽  
Controlled Trial ◽  
Bodyweight Gain ◽  
Metabolic Effects ◽  
Secondary Outcome ◽  
Standard Clinical Practice ◽  
Randomised Controlled

Background: People with schizophrenia have a 15–20-year reduction in life expectancy, driven in part by the metabolic effects of antipsychotics. Clozapine is associated with the highest rates of weight gain. As clozapine remains the most effective antipsychotic for treatment-resistant schizophrenia (TRS), identifying treatments to ameliorate clozapine-induced weight gain (CIWG) is urgently needed to reduce this morality gap. Methods: We retrospectively analysed digital health records of patients with TRS aged 18–65 newly initiated on clozapine at four tertiary hospitals in south-east Queensland from 1 March 2017 to 30 June 2019. Our primary outcome was the effect of metformin on change in percentage bodyweight at 12 months after clozapine initiation, with secondary outcome being proportion with >5% or >7% bodyweight change. We also explored impact on bodyweight change of other variables including sex, tobacco smoking, type 2 diabetes (T2DM), age, clozapine level and dose and clozapine/norclozapine ratio. Results: Among 90 patients initiated on clozapine, metformin use ( n = 48) was associated with a smaller increase in percentage bodyweight (1.32% versus 5.95%, p = 0.031), lower rates of >7% gain in bodyweight (37.8% versus 63.0%, p = 0.025) but not >5% gain in bodyweight. Age below the median (32.0 years) was associated with greater bodyweight gain (5.55% versus 1.22%, p = 0.046). Sex, tobacco smoking, T2DM, clozapine dose and level and clozapine/norclozapine ratio were not associated with differences in change in bodyweight. Conclusion: In this small retrospective cohort study, use of metformin within 12-months of clozapine initiation was associated with a statistically and clinically significant reduction in CIWG. Although there is increasing evidence for the role of metformin to ameliorate bodyweight gain at time of clozapine initiation, our findings need replication and testing in a randomised controlled trial before recommending metformin co-commencement with clozapine as standard clinical practice.

scholarly journals Brain Training and Sulforaphane Intake Interventions Separately Improve Cognitive Performance in Healthy Older Adults, Whereas a Combination of These Interventions Does Not Have More Beneficial Effects: Evidence from a Randomized Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 352
Author(s):  
Rui Nouchi ◽  
Qingqiang Hu ◽  
Toshiki Saito ◽  
Natasha Yuriko dos Santos Kawata ◽  
Haruka Nouchi ◽  
...  
Keyword(s):  
Older Adults ◽  
Active Control ◽  
Processing Speed ◽  
Cognitive Functions ◽  
Controlled Trial ◽  
Memory Performance ◽  
Brain Training ◽  
Beneficial Effects ◽  
Before And After ◽  
Double Blinded

Background: Earlier studies have demonstrated that a single-domain intervention, such as a brain-training (BT) game alone and a sulforaphane (SFN) intake, positively affects cognition. This study examined whether a combined BT and SFN intake intervention has beneficial effects on cognitive function in older adults. Methods: In a 12-week double-blinded randomized control trial, 144 older adults were randomly assigned to one of four groups: BT with SFN (BT-S), BT with placebo (BT-P), active control game (AT) with SFN (AT-S), and active control game with placebo (AT-P). We used Brain Age in BT and Tetris in AT. Participants were asked to play BT or AT for 15 min a day for 12 weeks while taking a supplement (SFN or placebo). We measured several cognitive functions before and after the intervention period. Results: The BT (BT-S and BT-P) groups showed more improvement in processing speed than the active control groups (AT-S and AT-P). The SFN intake (BT-S and AT-S) groups recorded significant improvements in processing speed and working memory performance unlike the placebo intake groups (BT-P and AT-P). However, we did not find any evidence of the combined intervention’s beneficial effects on cognition. Discussion: We discussed a mechanism to improve cognitive functions in the BT and SFN alone interventions.

scholarly journals Progression from external pilot to definitive randomised controlled trial: a methodological review of progression criteria reporting

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e048178
Author(s):  
Katie Mellor ◽  
Saskia Eddy ◽  
Nicholas Peckham ◽  
Christine M Bond ◽  
Michael J Campbell ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
A Priori ◽  
Pilot Trial ◽  
Public Library ◽  
Feasibility Studies ◽  
Methodological Review ◽  
Pilot Trials ◽  
Trial Protocols ◽  
Randomised Controlled

ObjectivesPrespecified progression criteria can inform the decision to progress from an external randomised pilot trial to a definitive randomised controlled trial. We assessed the characteristics of progression criteria reported in external randomised pilot trial protocols and results publications, including whether progression criteria were specified a priori and mentioned in prepublication peer reviewer reports.Study designMethodological review.MethodsWe searched four journals through PubMed: British Medical Journal Open, Pilot and Feasibility Studies, Trials and Public Library of Science One. Eligible publications reported external randomised pilot trial protocols or results, were published between January 2018 and December 2019 and reported progression criteria. We double data extracted 25% of the included publications. Here we report the progression criteria characteristics.ResultsWe included 160 publications (123 protocols and 37 completed trials). Recruitment and retention were the most frequent indicators contributing to progression criteria. Progression criteria were mostly reported as distinct thresholds (eg, achieving a specific target; 133/160, 83%). Less than a third of the planned and completed pilot trials that included qualitative research reported how these findings would contribute towards progression criteria (34/108, 31%). The publications seldom stated who established the progression criteria (12/160, 7.5%) or provided rationale or justification for progression criteria (44/160, 28%). Most completed pilot trials reported the intention to proceed to a definitive trial (30/37, 81%), but less than half strictly met all of their progression criteria (17/37, 46%). Prepublication peer reviewer reports were available for 153/160 publications (96%). Peer reviewer reports for 86/153 (56%) publications mentioned progression criteria, with peer reviewers of 35 publications commenting that progression criteria appeared not to be specified.ConclusionsMany external randomised pilot trial publications did not adequately report or propose prespecified progression criteria to inform whether to proceed to a future definitive randomised controlled trial.

scholarly journals Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Manaf AlQahtani ◽  
Abdulkarim Abdulrahman ◽  
Abdulrahman Almadani ◽  
Salman Yousif Alali ◽  
Alaa Mahmood Al Zamrooni ◽  
...  
Keyword(s):  
Standard Therapy ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Severe Disease ◽  
Pilot Trial ◽  
Standard Of Care ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Open Label ◽  
Plasma Therapy

AbstractConvalescent plasma (CP) therapy in COVID-19 disease may improve clinical outcome in severe disease. This pilot study was undertaken to inform feasibility and safety of further definitive studies. This was a prospective, interventional and randomized open label pilot trial in patients with severe COVID-19. Twenty COVID-19 patients received two 200 ml transfusions of convalescent patient CP over 24-h compared with 20 who received standard of care. The primary outcome was the requirement for ventilation (non-invasive or mechanical ventilation). The secondary outcomes were biochemical parameters and mortality at 28 days. The CP group were a higher risk group with higher ferritin levels (p < 0.05) though respiratory indices did not differ. The primary outcome measure was required in 6 controls and 4 patients on CP (risk ratio 0.67, 95% CI 0.22–2.0, p = 0.72); mean time on ventilation (NIV or MV) did not differ. There were no differences in secondary measures at the end of the study. Two patients died in the control and one patient in the CP arm. There were no significant differences in the primary or secondary outcome measures between CP and standard therapy, although a larger definitive study is needed for confirmation. However, the study did show that CP therapy appears to be safe in hospitalized COVID-19 patients with hypoxia.Clinical trials registration NCT04356534: 22/04/2020.

scholarly journals ‘Tracking Together’—Simultaneous Use of Human and Dog Activity Trackers: Protocol for a Factorial, Randomized Controlled Pilot Trial

2021 ◽  
Vol 18 (4) ◽  
pp. 1561
Author(s):  
Wasantha Jayawardene ◽  
Lesa Huber ◽  
Jimmy McDonnell ◽  
Laurel Curran ◽  
Sarah Larson ◽  
...  
Keyword(s):  
Physical Activity ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Activity Level ◽  
Analysis Of Covariance ◽  
Moderate Intensity ◽  
Randomized Controlled ◽  
Activity Trackers ◽  
Dog Owners ◽  
Simultaneous Use

Dog-walkers are more likely to achieve moderate-intensity physical activity. Linking the use of activity trackers with dog-walking may be beneficial both in terms of improving the targeted behavior and increasing the likelihood of sustained use. This manuscript aims to describe the protocol of a pilot study which intends to examine the effects of simultaneous use of activity trackers by humans and their dogs on the physical activity level of humans and dogs. This study uses nonprobability sampling of dog owners of age 25–65 (N = 80) and involves four parallel groups in an observational randomized controlled trial with a 2 × 2 factorial design, based on use of dog or human activity trackers for eight weeks. Each group consists of dog-human duos, in which both, either or none are wearing an activity tracker for eight weeks. At baseline and end, all human subjects wear ActiGraph accelerometers that quantify physical activity for one week. Commercial activity trackers are used for tracking human and dog activity remotely. Additional measures for humans are body composition and self-reported physical activity. Dog owners also report dog’s weight and physical activity using a questionnaire. A factorial analysis of covariance (ANCOVA) is used to compare physical activity across the four groups from baseline to week-10.

scholarly journals Feasibility of a clinical trial to assess the effect of dietary calciumv.supplemental calcium on vascular and bone markers in healthy postmenopausal women

2016 ◽  
Vol 116 (1) ◽  
pp. 104-114 ◽  
Author(s):  
Angel M. Ong ◽  
Hope A. Weiler ◽  
Michelle Wall ◽  
Rouba Haddad ◽  
Jessica Gorgui ◽  
...  
Keyword(s):  
Vitamin D ◽  
Postmenopausal Women ◽  
Large Scale ◽  
Bone Markers ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Diet Group ◽  
Pill Count ◽  
Present Trial ◽  
Vitamin D Supplement

AbstractWhether supplemental Ca has similar effects to dietary Ca on vascular and bone markers is unknown. The present trial investigated the feasibility of applying dietary and supplemental interventions in a randomised-controlled trial (RCT) aiming to estimate the effect of supplemental Ca as compared with dietary Ca on vascular and bone markers in postmenopausal women. In total, thirteen participants were randomised to a Ca supplement group (CaSuppl) (750 mg Ca from CaCO3+450 mg Ca from food+20 µg vitamin D supplement) or a Ca diet group (CaDiet) (1200 mg Ca from food+10 µg vitamin D supplement). Participants were instructed on Ca consumption targets at baseline. Monthly telephone follow-ups were conducted to assess adherence to interventions (±20 % of target total Ca) using the multiple-pass 24-h recall method and reported pill count. Measurements of arterial stiffness, peripheral blood pressure and body composition were performed at baseline and after 6 and 12 months in all participants who completed the trial (n9). Blood and serum biomarkers were measured at baseline and at 12 months. Both groups were compliant to trial interventions (±20 % of target total Ca intake; pill count ≥80 %). CaSuppl participants maintained a significantly lower average dietary Ca intake compared with CaDiet participants throughout the trial (453 (sd187) mg/dv.1241 (sd319) mg/d;P<0·001). There were no significant differences in selected vascular outcomes between intervention groups over time. Our pilot trial demonstrated the feasibility of conducting a large-scale RCT to estimate the differential effects of supplemental and dietary Ca on vascular and bone health markers in healthy postmenopausal women.

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