scholarly journals Improving chronic pain management with eHealth and mHealth: study protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e033586 ◽  
Author(s):  
Irene Jaén ◽  
Carlos Suso-Ribera ◽  
Diana Castilla ◽  
Irene Zaragoza ◽  
Azucena García-Palacios ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Web Application ◽  
Controlled Trial ◽  
Repeated Measure ◽  
Health Concern ◽  
Randomised Control Trial ◽  
Treatment As Usual ◽  
Use Of Technology ◽  
Public Costs ◽  
Randomised Controlled

IntroductionChronic pain has become a matter of public health concern due to its high prevalence and because public costs associated with treatment and disability increase each year. Research suggests that limitations in the traditional assessment of chronic pain patients limit the effectiveness of current medical treatments. The use of technology might serve change patient traditional monitoring into ecological momentary assessments, which might be visualised by physicians live. This study describes a randomised control trial designed to test the utility of a technology-based solution for pain telemonitoring consisting of a smartphone app for patients and a web application for physicians. The goal of this study will be to explore whether this combination of eHealth and mHealth improves the effectiveness of existing pain treatments.Methods and analysisParticipants will be 250 patients randomly assigned to one of these two conditions: treatment-as-usual (TAU) and TAU +app+ web. All participants will receive the usual treatment for their pain. Only the TAU +app+ web group use Pain Monitor app, which generates alarms that are sent to the physicians in the face of previously established undesired events. Physicians will be able to monitor app reports using a web application, which might result in an adjustment of treatment. We anticipate that the use of Pain Monitor plus the therapist web will result in a reduction of pain intensity and side effects of the medication. Improvements on secondary outcomes, namely fatigue, mood, pain interference, rescue medication use and quality of life, are also expected. Mixed repeated-measure multivariate analyses of variances will be conducted to investigate whether there are differences between preassessment and postassessment scores as a function of the experimental condition.Ethics and disseminationEthical approval from the Hospital General Universitari de Castellon was obtained. The findings will be published in peer-reviewed journals.Trial registration numberNCT03606265

scholarly journals Evaluating Palin Stammering Therapy for School Children (Palin STSC 8-14): Protocol for a Feasibility Randomised Control Trial Comparing Palin STSC(8-14) with Usual Treatment

2021 ◽  
Author(s):  
Sharon K Millard ◽  
Suzanne Murphy ◽  
Garry Barton ◽  
Maria Lethersich ◽  
Lorna Rixon ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Peer Relations ◽  
School Children ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Randomised Control Trial ◽  
Treatment As Usual ◽  
Children And Parents ◽  
Randomised Controlled ◽  
The Impact

Abstract Background: Having a stammer can have a significant effect on a child’s social, emotional and educational development. With approximately 66,000 children in the UK having a stammer, there is a need to establish an adequate evidence base to inform clinical practise. We describe a feasibility trial to explore the effectiveness of a new therapy programme for children aged 8-14: Palin Stammering Therapy for School Children (Palin STSC(8-14)). Preliminary data from the Michael Palin Centre, where the programme was developed, indicate that Palin STSC(8-14) is effective in reducing stammering frequency and impact for children, with beneficial effects for parents too. We will investigate the feasibility of the methods required for a definitive randomised control trial to investigate the application of this therapy by NHS speech and language therapists (SLTs), compared with ‘treatment as usual’ (TAU), beyond the specialist context in which it was developed.Methods: This is a two-arm feasibility cluster-randomised controlled trial of Palin STSC(8-14) with TAU control arm, and randomisation at the level of the SLT. Quantitative and qualitative data will be collected to examine: the recruitment and retention of therapists and families; the acceptability of the research processes and the therapeutic intervention; the appropriateness of the therapy outcome measures. Assessments will be completed by children and parents at baseline and six months later, including measures of: stammering severity; the impact of child’s stammering on both children and parents; child temperament, behaviour, peer relations, anxiety; quality of life; and, economic outcomes. There will also be a qualitative process evaluation, including interviews with parents, children, SLTs and SLT managers to explore the acceptability of both the research and therapy methods. Treatment fidelity will be examined through analysis of therapy session records and recordings. Discussion: The findings of this feasibility trial will inform the decision as to whether to progress to a full-scale randomised controlled trial to explore the effectiveness of Palin STSC(8-14) when compared to Treatment as Usual in NHS SLT services. There is a strong need for an evidence based intervention for school age children who stammer. Trial registration: ISRCTN. ISRCTN17058884. Registered 18th December 2019. https://www.isrctn.com/ISRCTN17058884

scholarly journals Effectiveness of Wellbeing Intervention for Chronic Kidney Disease (WICKD): results of a randomised controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Kylie M. Dingwall ◽  
Michelle Sweet ◽  
Alan Cass ◽  
Jaquelyne T. Hughes ◽  
David Kavanagh ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Kidney Disease ◽  
Controlled Trial ◽  
Psychosocial Interventions ◽  
Mental Wellbeing ◽  
Indigenous Australians ◽  
Treatment As Usual ◽  
Randomised Controlled ◽  
Hep B ◽  
Distress Scale

Abstract Background End stage kidney disease (ESKD) is associated with many losses, subsequently impacting mental wellbeing. Few studies have investigated the efficacy of psychosocial interventions for people with ESKD and none exist for Indigenous people, a population in which the ESKD burden is especially high. Methods This three-arm, waitlist, single-blind randomised controlled trial examined efficacy of the Stay Strong App in improving psychological distress (Kessler distress scale; K10), depressive symptoms (adapted Patient Health Questionnaire; PHQ-9), quality of life (EuroQoL; EQ. 5D) and dialysis adherence among Indigenous Australians undergoing haemodialysis in central and northern Australia (Alice Springs and Darwin), with follow up over two 3-month periods. Effects of immediate AIMhi Stay Strong App treatment were compared with those from a contact control app (The Hep B Story) and treatment as usual (TAU). Control conditions received the Stay Strong intervention after 3 months. Results Primary analyses of the full sample (N = 156) showed statistically significant decreases in K10 and PHQ-9 scores at 3 months for the Hep B Story but not for the Stay Strong app or TAU. Restricting the sample to those with moderate to severe symptoms of distress or depression (K10 > =25 or PHQ-9 > =10) showed significant decreases in K10 and PHQ-9 scores for both Stay Strong and Hep B Story. No significant differences were observed for the EQ-5D or dialysis attendance. Conclusions Findings suggest that talking to people about their wellbeing and providing information relevant to kidney health using culturally adapted, locally relevant apps improve the wellbeing of people on dialysis. Further research is required to replicate these findings and identify active intervention components. Trial registration ACTRN12617000249358; 17/02/2017.

scholarly journals Pharmacist-led management of chronic pain in primary care: costs and benefits in a pilot randomised controlled trial

BMJ Open ◽  
2015 ◽  
Vol 5 (4) ◽  
pp. e006874-e006874 ◽  
Author(s):  
A. R. Neilson ◽  
H. Bruhn ◽  
C. M. Bond ◽  
A. M. Elliott ◽  
B. H. Smith ◽  
...  
Keyword(s):  
Primary Care ◽  
Chronic Pain ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Costs And Benefits ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled ◽  
Care Costs

scholarly journals Influence of age on outcome of psychological treatments in first-episode psychosis

2006 ◽  
Vol 188 (3) ◽  
pp. 250-254 ◽  
Author(s):  
Gillian Haddock ◽  
Shôn Lewis ◽  
Richard Bentall ◽  
Graham Dunn ◽  
Richard Drake ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Behavioural Therapy ◽  
First Episode ◽  
Treatment As Usual ◽  
Psychological Treatments ◽  
Treatment Providers ◽  
Cognitive Behavioural ◽  
Episode Psychosis ◽  
Supportive Counselling ◽  
Randomised Controlled

BackgroundPsychological treatments have been shown to be effective in patients with psychosis. However, the studies published to date have included participants across wide age ranges, so few conclusions can be reached about the effectiveness of such treatments in relation to age.AimsTo evaluate outcomes by age in a randomised controlled trial designed to evaluate the effectiveness of cognitive-behavioural therapy (CBT), supportive counselling and treatment as usual.MethodOutcomes were evaluated in terms of symptoms, social functioning, insight and therapeutic alliance according to age at 3- and 18-month follow-up.ResultsYounger participants responded better to supportive counselling than to treatment as usual and CBTover 3 months. Older participants responded better to CBT than to supportive counselling over 18 months. Younger participants showed a greater increase in insight after CBT compared with treatment as usual and supportive counselling, and were more difficult to engage in therapy.ConclusionsYoung people may have different needs with regard to engagement in psychological treatments. Treatment providers need to take age-specific factors into account.

scholarly journals Effectiveness of one-to-one peer support for patients with severe mental illness – a randomised controlled trial

2017 ◽  
Vol 42 ◽  
pp. 103-110 ◽  
Author(s):  
C.I. Mahlke ◽  
S. Priebe ◽  
K. Heumann ◽  
A. Daubmann ◽  
K. Wegscheider ◽  
...  
Keyword(s):  
Mental Illness ◽  
Peer Support ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Treatment As Usual ◽  
Secondary Outcomes ◽  
One To One ◽  
Randomised Controlled

AbstractBackgroundOne-to-one peer support is a resource-oriented approach for patients with severe mental illness. Existing trials provided inconsistent results and commonly have methodological shortcomings, such as poor training and role definition of peer supporters, small sample sizes, and lack of blinded outcome assessments.MethodsThis is a randomised controlled trial comparing one-to-one peer support with treatment as usual. Eligible were patients with severe mental illnesses: psychosis, major depression, bipolar disorder or borderline personality disorder of more than two years’ duration. A total of 216 patients were recruited through in- and out-patient services from four hospitals in Hamburg, Germany, with 114 allocated to the intervention group and 102 to the control group. The intervention was one-to-one peer support, delivered by trained peers and according to a defined role specification, in addition to treatment as usual over the course of six months, as compared to treatment as usual alone. Primary outcome was self-efficacy measured on the General Self-Efficacy Scale at six-month follow-up. Secondary outcomes included quality of life, social functioning, and hospitalisations.ResultsPatients in the intervention group had significantly higher scores of self-efficacy at the six-month follow-up. There were no statistically significant differences on secondary outcomes in the intention to treat analyses.ConclusionsThe findings suggest that one-to-one peer support delivered by trained peer supporters can improve self-efficacy of patients with severe mental disorders over a one-year period. One-to-one peer support may be regarded as an effective intervention. Future research should explore the impact of improved self-efficacy on clinical and social outcomes.

scholarly journals Recruitment And Retention Of Participants From Socioeconomically Deprived Communities: Lessons From The Awareness And Beliefs About Cancer (ABACus3) Randomised Controlled Trial

2020 ◽  
Author(s):  
Vasiliki Kolovou ◽  
Yvonne Moriarty ◽  
Stephanie Gilbert ◽  
Harriet Quinn-Scoggins ◽  
Julia Townson ◽  
...  
Keyword(s):  
Financial Incentives ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Randomised Control Trial ◽  
Trial Participant ◽  
Community Settings ◽  
Research Strategies ◽  
Healthcare Settings ◽  
Randomised Controlled ◽  
Deprived Areas

Abstract Background Recruitment of research participants poses challenges in socioeconomically deprived areas. The Awareness and Beliefs About Cancer (ABACus) phase 3 Randomised Control Trial recruited adult participants from socioeconomically deprived areas using a combined healthcare/community engagement model. We report the strategies used to successfully recruit and retain our trial participant sample. Methods Community and healthcare settings in areas of high socioeconomic deprivation were identified by lay advisors who recruited participants opportunistically or by appointment. Follow-up was done by telephone or post at 2-weeks and 6-months after recruitment, and all participants were offered financial incentives. Qualitative interviews were conducted with lay advisors regarding their experience and reflections. Results The lay advisors identified and contacted 107 potential recruitment venues across South and West Yorkshire and South East Wales of which 41.1% (n = 42) were opened for recruitment. A total of 234 participants were recruited, with 91% (n = 212) retention at 2-weeks and 85% (n = 199) at 6-months. Community settings yielded 75% (n = 176) of participants. Participants had a mean age of 61.3 years and 63.3% (n = 148) were female, with 66% (n = 154) resident in the most deprived geographical areas. Lay advisors described recruitment as intensive, although engaging participants was easier in community settings. Conclusions The ABACus3 trial achieved recruitment and high retention with a population that is often “hard to reach” or entirely missed in health research. Strategies were specifically tailored to engage the venues and adult residents of highly deprived areas. Future studies recruiting adults living in the most deprived areas might benefit from community recruitment and from collaborating with local gatekeepers who are key to engagement.

scholarly journals Feasibility study on recruitment in general practice for a low back pain online information study (part of the ADVIN Back Trial)

2020 ◽  
Vol 13 (1) ◽  
Author(s):  
Allan Riis ◽  
Michael Skovdal Rathleff ◽  
Jan Hartvigsen ◽  
Janus Laust Thomsen ◽  
Tamana Afzali ◽  
...  
Keyword(s):  
General Practice ◽  
Low Back Pain ◽  
Back Pain ◽  
Randomised Controlled Trial ◽  
Web Application ◽  
Controlled Trial ◽  
Low Back ◽  
Loss To Follow Up ◽  
Randomised Controlled

Abstract Objective In a future full-scale randomised controlled trial, we plan to compare satisfaction with a standard website versus satisfaction with a participatory driven web-application. The participatory driven web-application may facilitate the delivery of targeted evidence-based advice and information to patients with low back pain in general practice (ClinicalTrials.gov Identifier: NCT03088774). This feasibility study is intended to inform a future randomised controlled trial. The aim is to report on the lessons learned from recruitment to report on reasons for loss to follow-up. Results We recruited 12 women and 8 men from two general practices with each practice recruiting for 3 months. Full follow-up data was available in only three patients (15%). Based on the high loss to follow-up, we do not consider it feasible to conduct the full-scale confirmatory trial as planned. Modifying inclusion criteria to include only patients expressing an interest in using online health information or randomising patients directly at the general practice, supporting them in accessing the web-application, and letting patients respond with their immediate satisfaction may improve the speed of recruitment and follow-up rates. Furthermore, the participatory driven web-application can be included in a larger multi-faceted intervention, making the combined intervention seem more relevant to study participants.

scholarly journals Cognitive–behavioural therapy for anxiety in dementia: pilot randomised controlled trial

2015 ◽  
Vol 206 (6) ◽  
pp. 509-516 ◽  
Author(s):  
Aimee Spector ◽  
Georgina Charlesworth ◽  
Michael King ◽  
Miles Lattimer ◽  
Susan Sadek ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Behavioural Therapy ◽  
Treatment As Usual ◽  
Pilot Randomised Controlled Trial ◽  
Cognitive Behavioural ◽  
Randomised Controlled ◽  
Effective Treatments

BackgroundAnxiety is common and problematic in dementia, yet there is a lack of effective treatments.AimsTo develop a cognitive–behavioural therapy (CBT) manual for anxiety in dementia and determine its feasibility through a randomised controlled trial.MethodA ten-session CBT manual was developed. Participants with dementia and anxiety (and their carers) were randomly allocated to CBT plus treatment as usual (TAU) (n= 25) or TAU (n= 25). Outcome and cost measures were administered at baseline, 15 weeks and 6 months.ResultsAt 15 weeks, there was an adjusted difference in anxiety (using the Rating Anxiety in Dementia scale) of (–3.10, 95% CI −6.55 to 0.34) for CBT compared with TAU, which just fell short of statistical significance. There were significant improvements in depression at 15 weeks after adjustment (–5.37, 95% CI −9.50 to −1.25). Improvements remained significant at 6 months. CBT was cost neutral.ConclusionsCBT was feasible (in terms of recruitment, acceptability and attrition) and effective. A fully powered RCT is now required.

scholarly journals Postcards from the EDge: 5-year outcomes of a randomised controlled trial for hospital-treated self-poisoning

2013 ◽  
Vol 202 (5) ◽  
pp. 372-380 ◽  
Author(s):  
Gregory L. Carter ◽  
Kerrie Clover ◽  
Ian M. Whyte ◽  
Andrew H. Dawson ◽  
Catherine D'Este
Keyword(s):  
Randomised Controlled Trial ◽  
Psychiatric Hospital ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Treatment As Usual ◽  
Psychiatric Admissions ◽  
Bed Days ◽  
Randomised Controlled ◽  
Event Rates

BackgroundRepetition of hospital-treated self-poisoning and admission to psychiatric hospital are both common in individuals who self-poison.AimsTo evaluate efficacy of postcard intervention after 5 years.MethodA randomised controlled trial of individuals who have self-poisoned: postcard intervention (eight in 12 months) plus treatment as usualv.treatment as usual. Our primary outcomes were self-poisoning admissions and psychiatric admissions (proportions and event rates).ResultsThere was no difference between groups for any repeat-episode self-poisoning admission (intervention group: 24.9%, 95% CI 20.6-29.5; control group: 27.2%, 95% CI 22.8-31.8) but there was a significant reduction in event rates (incidence risk ratio (IRR)=0.54, 95% CI 0.37-0.81), saving 306 bed days. There was no difference for any psychiatric admission (intervention group: 38.1%, 95% CI 33.1-43.2; control group: 35.5%, 95% CI 30.8-40.5) but there was a significant reduction in event rates (IRR=0.66, 95% CI 0.47-0.91), saving 2565 bed days.ConclusionsA postcard intervention halved self-poisoning events and reduced psychiatric admissions by a third after 5 years. Substantial savings occurred in general hospital and psychiatric hospital bed days.

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