Does handwriting the name of a potential trial participant on an invitation letter improve recruitment rates? A randomised controlled study within a trial

Background: Randomised controlled trials (RCTs) often fail to recruit to target, resulting in a lack of generalisability of findings. A wide range of strategies for potentially increasing recruitment have been identified; however, their effectiveness has not been established. The aim of this study within a trial (SWAT) was to evaluate the effectiveness of handwritten personalisation of an invitation letter as part of a trial recruitment pack on recruitment to a host RCT. Methods: A pragmatic, two-armed RCT was conducted, embedded within an existing falls prevention trial (OTIS) in men and women aged 65 years and over living in the community. Participants were randomised 1:1 to receive an OTIS recruitment pack containing an invitation letter on which their name was handwritten (intervention group), or one on which it was printed (control group). The primary outcome was randomisation into the host trial. Secondary outcomes related to trial eligibility and retention. Analyses were via logistic regression and Cox Proportional Hazards regression. Results: Of the 317 SWAT participants, 12 (3.8%) were randomised into the OTIS trial: 3 (handwritten: 3/159 [1.9%]; printed: 9/158 [5.7%]; difference -3.8%, 95% CI -8.0% to 0.4%). There was weak evidence, against the intervention, of a difference in the likelihood of participants being randomised into the host trial between the two groups (OR 0.32, 95% CI 0.08 to 1.20, p=0.09). There were no statistically significant differences between the intervention and control groups on any of the secondary outcomes. Conclusions: There was no evidence that personalisation of invitation letters improved recruitment to the OTIS trial. However, due to the small sample size, the results should be interpreted with caution. These findings need to be replicated across larger studies and wider populations. Registration: ISRCTN22202133.

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Protocol for a randomised, open-label, parallel group, multicentre controlled study to evaluate the clinical performance and safety of Stay Safe Link compared with Stay Safe in patients with end-stage kidney disease on continuous ambulatory peritoneal dialysis

BMJ Open ◽

10.1136/bmjopen-2018-024589 ◽

2019 ◽

Vol 9 (3) ◽

pp. e024589

Author(s):

Wen Yao Mak ◽

Loke Meng Ong ◽

Bak Leong Goh ◽

Sunita Bavanandan ◽

Lily Mushahar ◽

...

Keyword(s):

Peritoneal Dialysis ◽

Randomised Controlled Trial ◽

Continuous Ambulatory Peritoneal Dialysis ◽

Controlled Trial ◽

Intervention Group ◽

Controlled Study ◽

Control Group ◽

Open Label ◽

Randomised Controlled ◽

End Stage

IntroductionPeritonitis is a major complication of continuous ambulatory peritoneal dialysis (CAPD), the risk of which is significantly influenced by the type of PD transfer system. Although the Y-disconnect and double-bag system is more efficient in preventing peritonitis compared with the spike system, little information is available to differentiate risks between different brands of the Y-disconnect double-bag system. A randomised controlled trial to evaluate the safety and efficacy of a newly introduced system is needed to provide the necessary clinical evidence to guide policy decision-making.Methods and analysisThe study is an open-label randomised controlled trial. A total of 434 patients with end-stage renal disease undergoing CAPD will be enrolled and randomised to either the intervention group, Stay Safe Link, or the control group, Stay Safe. All study subjects will be followed up and monitored for 1 year. The primary safety outcome is the rate of peritonitis while the primary efficacy outcomes are the delivered dialysis dose and ultrafiltration volume.Ethics and disseminationThe study was approved by the Medical Research Ethics Committee, National Institute of Health Malaysia. A written informed consent will be obtained from all participating subjects prior to any trial-related procedure and the study conduct will adhere strictly to Good Clinical Practice. The findings will be disseminated in a peer-reviewed journal.Trial registration numberNCT03177031; Pre-results.

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Breast cancer application protocol: a randomised controlled trial to evaluate a self-management app for breast cancer survivors

BMJ Open ◽

10.1136/bmjopen-2019-034655 ◽

2020 ◽

Vol 10 (7) ◽

pp. e034655

Author(s):

Andy S K Cheng ◽

Xiangyu Liu ◽

Peter H F Ng ◽

Cindy T T Kwok ◽

Yingchun Zeng ◽

...

Keyword(s):

Breast Cancer ◽

Breast Cancer Survivors ◽

Controlled Trial ◽

Intervention Group ◽

Readiness For Change ◽

Self Management ◽

Controlled Study ◽

Control Group ◽

Problem Solving Skills ◽

Randomised Controlled

IntroductionThe eHealth technologies that are being designed for chronic disease constitute a global trend towards health assessment and self-management. However, most of these approaches tend to focus on a single symptom or problem rather than on the multiple problems that are characteristic of many of these chronic illnesses. The aim of this study is to examine the effectiveness of and adherence to a self-management application (app) that identifies multiple problem areas related to surviving breast cancer as the targeted chronic illness.Methods and analysisThis is a randomised controlled study. Eligible participants will be allocated randomly into either an intervention group or a control group at a 1:1 ratio. The intervention group will be assigned to the self-management app (‘Be-with-You’), while the control group will use a general health app (‘Sham’ app). The primary outcomes will include the differences between the two groups in their health literacy, problem-solving skills and self-management skills. The secondary outcomes will include group differences in self-efficacy, readiness for change and health-related quality of life. All of these outcomes will be measured at baseline and at 4 weeks and 12 weeks after intervention. In addition, usability of these two mobile apps will be measured at 4 weeks and 12 weeks after intervention. The planned sample size is 476.Ethics and disseminationThe Human Subjects Ethics Sub-committee of The Hong Kong Polytechnic University approved the study (HSEARS20190922001, 24 September 2019). Dissemination of findings will occur at the local, national and international levels.Trial registration numberChiCTR1900026244.

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A Multicentre Randomised Controlled Study Evaluating the Effect of a Standardised Education Programme on Quality of Life, Disease Severity, and Disease Knowledge in Patients with Moderate-To-Severe Psoriasis: The EDUPSO Study

Dermatology ◽

10.1159/000520289 ◽

2021 ◽

pp. 1-10

Author(s):

Fatma Jendoubi ◽

Stefana Balica ◽

Marie Aleth Richard ◽

Christine Chiaverini ◽

Claire Bernier ◽

...

Keyword(s):

Patient Satisfaction ◽

Intervention Group ◽

Education Programme ◽

Controlled Study ◽

Control Group ◽

Randomised Controlled Study ◽

Randomised Controlled ◽

To Receive

Background: Psoriasis is a chronic inflammatory skin disease that has a profound effect on health-related quality of life (HRQoL). Patient education programmes may help patients to gain life-long control over their chronic disease. Objective: This multicentre randomised controlled study evaluated whether a standardised multidisciplinary education programme was beneficial to psoriasis patients. Methods: Adults with moderate-to-severe psoriasis were randomly assigned (1:1) to an intervention group to receive an educational programme or to a control group to receive usual care. Randomization was stratified by previous treatment history. The primary outcome was HRQoL, assessed by scoring the Skindex-29 domains emotion, symptom, and functioning. Psoriasis severity was assessed using the psoriasis area severity index (PASI). Levels of perceived stress, patient knowledge about psoriasis, and patient satisfaction were also assessed. Follow-up evaluations were performed at 3, 6, and 12 months. Results: A total 142 patients formed the intention-to-treat population: 70 in the control group and 72 in the intervention group. Skindex component scores and the PASI were significantly lower at 3, 6, and 12 months as compared to baseline in both groups, but no significant differences were found between the groups. Knowledge about psoriasis improved significantly during follow-up amongst patients from the intervention group compared to controls (68% of correct answers vs. 56%; p < 0.01). Patient satisfaction with psoriasis management and treatment was also better in the intervention group. Conclusions: The standardised education programme did not improve HRQoL and disease severity in psoriasis, but led to a significant improvement in patient knowledge about the disease and increased patient satisfaction.

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Effect of therapeutic suggestions during general anaesthesia on postoperative pain and opioid use: multicentre randomised controlled trial

BMJ ◽

10.1136/bmj.m4284 ◽

2020 ◽

pp. m4284 ◽

Cited By ~ 1

Author(s):

Hartmuth Nowak ◽

Nina Zech ◽

Sven Asmussen ◽

Tim Rahmel ◽

Michael Tryba ◽

...

Keyword(s):

Postoperative Pain ◽

Confidence Interval ◽

General Anaesthesia ◽

Intervention Group ◽

Controlled Study ◽

Control Group ◽

Number Needed To Treat ◽

Opioid Use ◽

Number Of Patients ◽

Randomised Controlled

Abstract Objective To investigate the effect of therapeutic suggestions played to patients through earphones during surgery on postoperative pain and opioid use. Design Blinded randomised controlled study. Setting Five tertiary care hospitals in Germany. Participants 385 of 400 patients consecutively recruited from January to December 2018 who were to undergo surgery for 1-3 hours under general anaesthesia. In the per protocol analysis 191 patients were included in the intervention group and 194 patients in the control group. Intervention The intervention comprised an audiotape of background music and positive suggestions based on hypnotherapeutic principles, which was played repeatedly for 20 minutes followed by 10 minutes of silence to patients through earphones during general anaesthesia. Patients in the control group were assigned to a blank tape. Main outcome measures The main outcome was dose of opioid administered by patient controlled analgesia or nurse controlled analgesia within the first postoperative 24 hours, based on regular evaluation of pain intensity on a numerical rating scale (range 0-10, with higher scores representing more severe pain). Results Compared with the control group, the intervention group required a significantly (P=0.002) lower opioid dose within 24 hours after surgery, with a median of 4.0 mg (interquartile range 0-8) morphine equivalents versus 5.3 (2-12), and an effect size (Cohen’s d) of 0.36 (95% confidence interval 0.16 to 0.56). The number of patients who needed opioids postoperatively was significantly (P=0.001) reduced in the intervention group: 121 of 191 (63%, 95% confidence interval 45% to 70%) patients in the intervention group versus 155 of 194 (80%, 74% to 85%) in the control group. The number needed to treat to avoid postoperative opioids was 6. Pain scores were consistently and significantly lower in the intervention group within 24 hours after surgery, with an average reduction of 25%. No adverse events were reported. Conclusions Therapeutic suggestions played through earphones during general anaesthesia could provide a safe, feasible, inexpensive, and non-drug technique to reduce postoperative pain and opioid use, with the potential for more general use. Based on the finding of intraoperative perception by a considerable number of patients, surgeons and anaesthetists should be careful about background noise and conversations during surgery. Trial registration German Clinical Trial Register DRKS00013800.

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Short-term effect of a chronic pain self-management intervention delivered by an easily accessible primary healthcare service: a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2018-023017 ◽

2018 ◽

Vol 8 (12) ◽

pp. e023017 ◽

Cited By ~ 2

Author(s):

Torunn Hatlen Nøst ◽

Aslak Steinsbekk ◽

Ola Bratås ◽

Kjersti Grønning

Keyword(s):

Chronic Pain ◽

Healthcare Service ◽

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Patient Activation ◽

Self Management ◽

Control Group ◽

Secondary Outcomes ◽

Randomised Controlled

ObjectivesTo investigate the effects on persons with chronic pain after 3 months of a group-based chronic pain self-management course compared with a drop-in, low-impact outdoor physical group activity on patient activation and a range of secondary outcomes.DesignAn open, pragmatic, parallel group randomised controlled trial. Analyses were performed using a two-level linear mixed model.SettingAn easily accessible healthcare service provided by Norwegian public primary healthcare.ParticipantsA total of 121 participants with self-reported chronic pain for 3 months or more were randomised with 60 participants placed in the intervention group and 61 placed in the control group (mean age 53 years, 88% women, 63% pain for 10 years or more).InterventionsThe intervention group was offered a group-based chronic pain self-management course with 2.5-hour weekly sessions for a period of 6 weeks. The sessions consisted of education, movement exercises and emphasised group discussions. The control group was offered a low-impact outdoor group physical activity in 1-hour weekly sessions that consisted of walking and simple strength exercises for a period of 6 weeks.Main outcomesThe primary outcome was patient activation assessed using the Patient Activation Measure. Secondary outcomes measured included assessments of pain, anxiety and depression, pain self-efficacy, sense of coherence, health-related quality of life, well-being and the 30 s chair to stand test.ResultsThere was no effect after 3 months of the group-based chronic pain self-management course compared with the control group for the primary outcome, patient activation (estimated mean difference: −0.5, 95% CI –4.8 to 3.7, p=0.802).ConclusionsThere was no support for the self-management course having a better effect after 3 months than a low-impact outdoor physical activity offered the control group.Trial registration numberNCT02531282; Results.

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The efficacy of motivational counselling and SMS reminders on daily sitting time in patients with rheumatoid arthritis: a randomised controlled trial

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2016-210953 ◽

2017 ◽

Vol 76 (9) ◽

pp. 1603-1606 ◽

Cited By ~ 34

Author(s):

Tanja Thomsen ◽

Mette Aadahl ◽

Nina Beyer ◽

Merete Lund Hetland ◽

Katrine Løppenthin ◽

...

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Sitting Time ◽

Control Group ◽

Behavioural Intervention ◽

Secondary Outcomes ◽

Randomised Controlled ◽

General Self Efficacy ◽

Motivational Counselling

ObjectivesThe aim of this report is to investigate the efficacy of an individually tailored, theory-based behavioural intervention for reducing daily sitting time, pain and fatigue, as well as improving health-related quality of life, general self-efficacy, physical function and cardiometabolic biomarkers in patients with rheumatoid arthritis (RA).MethodsIn this randomised controlled trial 150 patients with RA were randomised to an intervention or a no-intervention control group. The intervention group received three individual motivational counselling sessions and short message service or text messages aimed at reduction of sedentary behaviour during the 16-week intervention period. Primary outcome was change in daily sitting time measured objectively by ActivPAL. Secondary outcomes included change in pain, fatigue, physical function, general self-efficacy, quality of life, blood pressure, blood lipids, haemoglobin A1c, body weight, body mass index, waist circumference and waist–hip ratio.Results75 patients were allocated to each group. Mean reduction in daily sitting time was −1.61 hours/day in the intervention versus 0.59 hours/day increase in the control group between-group difference −2.20 (95% CI −2.72 to −1.69; p<0.0001) hours/day in favour of the intervention group. Most of the secondary outcomes were also in favour of the intervention.ConclusionAn individually tailored, behavioural intervention reduced daily sitting time in patients with RA and improved patient-reported outcomes and cholesterol levels.Trial registration numberNCT01969604; Results.

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Effectiveness of the eCARE programme: a short message service for asthma monitoring

BMJ Health & Care Informatics ◽

10.1136/bmjhci-2019-100007 ◽

2019 ◽

Vol 26 (1) ◽

pp. e100007

Author(s):

Lathy Prabhakaran ◽

Yap Chun Wei

Keyword(s):

Asthma Control ◽

Short Message Service ◽

Intervention Group ◽

Routine Care ◽

Controlled Study ◽

Care Group ◽

Control Group ◽

Short Message ◽

Message Service ◽

Randomised Controlled

ObjectiveTo evaluate the effectiveness of the upgraded eCARE monitoring system on asthma control in discharged emergency department (ED) patients.MethodsA multicentre randomised controlled study (randomised controlled trial) was done for patients with a primary diagnosis of asthma seen at the EDs in Singapore between 1 March 2013 and 28 February 2015. Those who met the inclusion criteria were randomised into a control group (routine care, n=212) and intervention group (eCARE, n=212). Patients in the intervention group received short message service (SMS) messages according to a structured workﬂow, while patients in the control group did not receive SMS support.ResultsFor patients with poorly controlled asthma at recruitment, the results at 5 weeks showed no statistical difference in the proportion of patients who attained well-controlled asthma between the eCARE and routine care groups. At 3 months, the routine care group had a higher proportion of patients with well-controlled asthma but this was not statistically significant after adjustment for baseline differences using logistic regression. Approximately 95% of patients under the eCARE programme were satisfied with the SMS service.DiscussionPatients in the eCARE programme did not have better asthma control than those receiving routine care. Conversely, patients in the eCARE programme appeared to have poorer asthma control, though a larger sample size will be required to confirm this finding.

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The MOSEXY trial: mobile phone intervention for sexual health in youth—a pragmatic randomised controlled trial to evaluate the effect of a smartphone application on sexual health in youth in Stockholm, Sweden

Sexually Transmitted Infections ◽

10.1136/sextrans-2019-054027 ◽

2019 ◽

pp. sextrans-2019-054027

Author(s):

Anna Maria Nielsen ◽

Ayesha De Costa ◽

Kristina Gemzell-Danielsson ◽

Gaetano Marrone ◽

Jens Boman ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Sexual Health ◽

Condom Use ◽

Controlled Trial ◽

Intervention Group ◽

Smartphone Application ◽

Consistent Condom ◽

Control Group ◽

Secondary Outcomes ◽

Randomised Controlled

An estimated 350 million cases of STIs occur globally each year. In Sweden, Chlamydia is the most common STI with approximately 30 000 cases annually, disproportionally affecting youth. National surveys report low condom use among youth. Smartphone coverage is high among this tech-savvy group. In collaboration with youth, we developed an interactive smartphone application comprising games, peer experiences and information snippets to promote condom use.ObjectivesTo evaluate in a randomised controlled trial, the effectiveness of this smartphone application to improve condom use among youth in Stockholm, Sweden.MethodsThis two-arm, individually randomised controlled trial was implemented through the Youth Health Clinics (YHC) in Stockholm, Sweden. Youth aged 18–23 years, who owned a smartphone and had ≥2 sexual partners during the past 6 months were eligible. The intervention delivered the interactive elements described above over 180 days. The control group received a ‘dummy’ application. Both groups received standard of care at the YHC. The primary outcome was proportion of consistent (100%) self-reported condom use at 6 months. Secondary outcomes included self-reported number of partners, occurrence of STIs/pregnancy and STI tests during the study period. An intention-to-treat approach was used.Results214 and 219 youth were randomised to the intervention and control groups, respectively. Consistent condom use was reported for 32/214 (15.0%) in the intervention group and for 35/219 (16.0%) in the control group (OR 0.9, 95% CI 0.5 to 1.6). No significant differences in secondary outcomes were seen.ConclusionWe were unable to detect an effect of the intervention. Future research should focus on targeting different subgroups within the overall risk group, with tailored mHealth interventions. The potential for such interventions in settings where sexual health services are unavailable should be evaluated.Trial registration numberISRCTN13212899.

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Efficacy of a Multi-component m-Health Weight-loss Intervention in Overweight and Obese Adults: A Randomised Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17176200 ◽

2020 ◽

Vol 17 (17) ◽

pp. 6200

Author(s):

Mitch Duncan ◽

Sasha Fenton ◽

Wendy Brown ◽

Clare Collins ◽

Nicholas Glozier ◽

...

Keyword(s):

Physical Activity ◽

Weight Loss ◽

Body Weight ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Obese Adults ◽

Secondary Outcomes ◽

Randomised Controlled

Background: This study compared the efficacy of two multi-component m-health interventions with a wait-list control group on body weight (primary outcome), and secondary outcomes of cardiovascular risk factors, lifestyle behaviours, and mental health. Methods: Three-arm randomised controlled trial (Enhanced: physical activity, diet, sleep, Traditional: physical activity, diet, Control) with assessments conducted at baseline, 6 and 12 months. Participants (n = 116) were overweight or obese adults aged 19–65 (M = 44.5 [SD = 10.5]). The 6-month intervention was delivered via a smartphone app providing educational materials, goal-setting, self-monitoring and feedback, and also included one face-to-face dietary consultation, a Fitbit and scales. The trial was prospectively registered and conducted between May 2017 and September 2018. Group differences on primary and secondary outcomes were examined between the Pooled Intervention groups (Pooled Intervention = Enhanced and Traditional) and Control groups, and then between Enhanced and Traditional groups. Results: Nineteen participants (16.4%) formally withdrew from the trial. Compared with the Control group, average body weight of the Pooled Intervention group did not differ at 6 (between-group difference = −0.92, (95% CI −3.33, 1.48)) or 12 months (0.00, (95% CI −2.62, 2.62)). Compared with the Control group, the Pooled Intervention group significantly increased resistance training (OR = 7.83, (95% CI 1.08, 56.63)) and reduced energy intake at 6 months (−1037.03, (−2028.84, −45.22)), and improved insomnia symptoms at 12 months (−2.59, (−4.79, −0.39)). Compared with the Traditional group, the Enhanced group had increased waist circumferences (2.69, (0.20, 5.18)) and sedentary time at 6 months (105.66, (30.83, 180.48)), and improved bed time variability at 12 months (−1.08, (−1.86, −0.29)). No other significant differences were observed between groups. Conclusions: Relative to Controls, the Pooled Intervention groups did not differ on body weight but improved resistance training, and reduced energy intake and insomnia symptom severity. No additional weight loss was apparent when targeting improvements in physical activity, diet and sleep in combination compared with physical activity and diet.

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Effect of the Pregnant+ smartphone application in women with gestational diabetes mellitus: a randomised controlled trial in Norway

BMJ Open ◽

10.1136/bmjopen-2019-030884 ◽

2019 ◽

Vol 9 (11) ◽

pp. e030884 ◽

Cited By ~ 3

Author(s):

Iren Borgen ◽

Milada Cvancarova Småstuen ◽

Anne Flem Jacobsen ◽

Lisa Maria Garnweidner-Holme ◽

Seraj Fayyad ◽

...

Keyword(s):

Blood Glucose ◽

Blood Glucose Level ◽

Usual Care ◽

Glucose Level ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Feeding Practice ◽

Secondary Outcomes ◽

Randomised Controlled

ObjectiveTo assess the effect of the Pregnant+ app on the 2-hour glucose level of the routine postpartum oral glucose tolerance test (OGTT) among women with gestational diabetes mellitus (GDM). The Pregnant+ app was designed to provide information about GDM, and promote physical activity and a healthy diet.DesignA multicentre, non-blinded randomised controlled trial.SettingFive diabetes outpatient clinics in the Oslo region.ParticipantsWomen ≥18 years old with a 2-hour OGTT blood glucose level ≥9 mmol/L who owned a smartphone; understood Norwegian, Urdu or Somali; and were <33 weeks pregnant. A total of 238 women were randomised; 158 women completed the OGTT post partum.InterventionThe Pregnant+ app and usual care, the control group received usual care.Primary and secondary outcomesThe primary outcome was the 2-hour blood glucose level of the routine postpartum OGTT. Secondary outcomes reported were mode of delivery, induction of labour, Apgar score, birth weight, transfer to the neonatal intensive care unit and breast feeding practice. Blood glucose levels during pregnancy, knowledge of diabetes, diet and physical activity are not reported.ResultsNo difference was found for the 2-hour blood glucose level of the postpartum OGTT, with 6.7 mmol/L (95% CI 6.2 to 7.1) in the intervention group and 6.0 mmol/L (95% CI 5.6 to 6.3) in the control group. The significant difference in the proportion of emergency caesarean sections between the intervention group, 10 (8.8%) and the usual care group, 27 (22.1%), disappeared when adjusted for parity. There were no differences in birth weight, breast feeding practice, obstetric complications or transfer to the intensive neonatal care unit. No adverse events were registered.ConclusionThe Pregnant+ app had no effect on 2-hour glucose level at routine postpartum OGTT. After controlling for parity, the difference in emergency caesarean section was not statistically significant.Trial registration numberNCT02588729.

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