Impact of Patient-Held Record on Knowledge at 1-Year Follow-Up for Glaucoma Patients: Single-Center Randomized Controlled Trial

Purpose To assess whether provision of a personalized patient-held eye health summary (glaucoma personal record) improves patients’ knowledge of glaucoma at 1-year follow-up. The National Institute for Clinical Excellence has recommended such an approach to ascertain if this may ultimately help slow disease progression. Methods Recruited patients, newly diagnosed with glaucoma conditions, were randomly allocated to receive standard clinical care or an additional glaucoma personal record, detailing the current state of each individual's eye condition. Mann-Whitney U test was applied for comparison of knowledge scores between groups at 1-year follow-up, using a validated questionnaire. Multiple linear regression analysis was applied to detect any factors significantly associated with a difference in glaucoma knowledge. Results A total of 122 patients were recruited; 57 controls and 44 intervention patients were tested for their glaucoma knowledge, equating to 83% retention rate. Out of a maximum available 100% converted score, the median scores were 58% and 53% for the control and intervention arm, respectively (p = 0.85). Regression analysis showed that age (p = 0.015) had a negative association and level of education (p = 0.002) had a positive association with glaucoma knowledge. Conclusions The glaucoma personal record does not impact on a patient's knowledge of glaucoma in either a positive or negative way. Other approaches to improve health literacy among glaucoma patients, particularly for patients who are elderly or have a limited educational background, must be considered to improve patients’ awareness and knowledge of their own condition. Trial registration International Standard Randomized Controlled Trial Number Registry: ISRCTN41306818.

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A Web-Based, Computer-Tailored Intervention to Reduce Alcohol Consumption and Binge Drinking Among Spanish Adolescents: Cluster Randomized Controlled Trial (Preprint)

10.2196/preprints.15438 ◽

2019 ◽

Author(s):

José Manuel Martinez-Montilla ◽

Liesbeth Mercken ◽

Hein de Vries ◽

Math Candel ◽

Joaquín Salvador Lima-Rodríguez ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Regression Analysis ◽

Alcohol Consumption ◽

Alcohol Use ◽

Controlled Trial ◽

Baseline Assessment ◽

Web Based ◽

Randomized Controlled ◽

Cluster Randomized

BACKGROUND Alcohol consumption, including binge drinking (BD) and heavy episodic drinking (HED), is one of the leading risk factors among Spanish adolescents leading to significant social, health, and economic consequences. Reduction of BD and HED in adolescents can be achieved using Web-based, computer-tailored (CT) interventions, providing highly personalized feedback that is adapted to a person’s individual characteristics and needs. Randomized controlled trials assessing the effects of tailored BD reduction programs among Spanish adolescents are scarce. OBJECTIVE The aim of this study was to test the effectiveness of the Web-based, CT intervention Alerta Alcohol, aimed at the prevention of BD in Spanish adolescents. As a secondary outcome, effects on HED, weekly consumption, and any consumption were also assessed. The adherence and process evaluation were assessed. METHODS A cluster randomized controlled trial conducted among 15 Spanish schools was developed. Each school was randomized into either an experimental condition (EC) (N=742) or a control condition (CC) (N=505). Finally, 351 participants for the EC and 261 for the CC were included in the analysis (N=612). Baseline assessment took place in January and February 2017. Demographic variables and alcohol use were assessed at baseline. Follow-up assessment of alcohol use took place 4 months later in May and June 2017. Participants were compared according to their randomization group (EC versus CC). After the baseline assessment, participants in the EC started the intervention, which consisted of short stories about BD, in which CT feedback was based on the I-Change Model for behavior change. Participants in the CC group only received the baseline questionnaire. Effects of the intervention were assessed using a three-level mixed logistic regression analysis for BD, HED, and any consumption, and a three-level mixed linear regression analysis for weekly consumption. RESULTS In total, 1247 adolescents participated in the baseline assessment and 612 participated in the follow-up assessment; the attrition rate was 50.92%. The intervention was effective in reducing HED among adolescents; the odds of HED in the CC was nine times that in the experimental condition (<i>P</i>=.04). No effects were found for BD, weekly consumption, and any consumption. Process evaluations revealed that the adolescents were satisfied with the program (68.8%), would use the program again (52.9%), and would recommend it to someone else (62.8%). Females and non-binge drinkers showed better responses in the process evaluation. CONCLUSIONS Our intervention was effective regarding HED but not regarding BD, weekly consumption, and any consumption. It may be that limiting alcohol consumption to prevent HED was easier in the Spanish context than it was to carry out further steps, such as reducing other patterns of alcohol consumption. Hence, additional actions are needed to accomplish these latter goals, including community approaches and policy actions aimed at denormalizing alcohol consumption among Spanish adolescents. CLINICALTRIAL ClinicalTrials.gov NCT03288896; https://clinicaltrials.gov/ct2/show/NCT03288896 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12889-018-5346-4

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Treating severe and enduring anorexia nervosa: a randomized controlled trial

Psychological Medicine ◽

10.1017/s0033291713000949 ◽

2013 ◽

Vol 43 (12) ◽

pp. 2501-2511 ◽

Cited By ~ 118

Author(s):

S. Touyz ◽

D. Le Grange ◽

H. Lacey ◽

P. Hay ◽

R. Smith ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Anorexia Nervosa ◽

Eating Disorder ◽

Social Adjustment ◽

Retention Rate ◽

Behavioral Therapy ◽

Controlled Trial ◽

Retention Rates ◽

Randomized Controlled

BackgroundThere are no evidence-based treatments for severe and enduring anorexia nervosa (SE-AN). This study evaluated the relative efficacy of cognitive behavioral therapy (CBT-AN) and specialist supportive clinical management (SSCM) for adults with SE-AN.MethodSixty-three participants with a diagnosis of AN, who had at least a 7-year illness history, were treated in a multi-site randomized controlled trial (RCT). During 30 out-patient visits spread over 8 months, they received either CBT-AN or SSCM, both modified for SE-AN. Participants were assessed at baseline, end of treatment (EOT), and at 6- and 12-month post-treatment follow-ups. The main outcome measures were quality of life, mood disorder symptoms and social adjustment. Weight, eating disorder (ED) psychopathology, motivation for change and health-care burden were secondary outcomes.ResultsThirty-one participants were randomized to CBT-AN and 32 to SSCM with a retention rate of 85% achieved at the end of the study. At EOT and follow-up, both groups showed significant improvement. There were no differences between treatment groups at EOT. At the 6-month follow-up, CBT-AN participants had higher scores on the Weissman Social Adjustment Scale (WSAS; p = 0.038) and at 12 months they had lower Eating Disorder Examination (EDE) global scores (p = 0.004) and higher readiness for recovery (p = 0.013) compared to SSCM.ConclusionsPatients with SE-AN can make meaningful improvements with both therapies. Both treatments were acceptable and high retention rates at follow-up were achieved. Between-group differences at follow-up were consistent with the nature of the treatments given.

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A Web-Based, Computer-Tailored Intervention to Reduce Alcohol Consumption and Binge Drinking Among Spanish Adolescents: Cluster Randomized Controlled Trial

Journal of Medical Internet Research ◽

10.2196/15438 ◽

2020 ◽

Vol 22 (1) ◽

pp. e15438

Author(s):

José Manuel Martinez-Montilla ◽

Liesbeth Mercken ◽

Hein de Vries ◽

Math Candel ◽

Joaquín Salvador Lima-Rodríguez ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Regression Analysis ◽

Alcohol Consumption ◽

Alcohol Use ◽

Controlled Trial ◽

Baseline Assessment ◽

Web Based ◽

Randomized Controlled ◽

Cluster Randomized

Background Alcohol consumption, including binge drinking (BD) and heavy episodic drinking (HED), is one of the leading risk factors among Spanish adolescents leading to significant social, health, and economic consequences. Reduction of BD and HED in adolescents can be achieved using Web-based, computer-tailored (CT) interventions, providing highly personalized feedback that is adapted to a person’s individual characteristics and needs. Randomized controlled trials assessing the effects of tailored BD reduction programs among Spanish adolescents are scarce. Objective The aim of this study was to test the effectiveness of the Web-based, CT intervention Alerta Alcohol, aimed at the prevention of BD in Spanish adolescents. As a secondary outcome, effects on HED, weekly consumption, and any consumption were also assessed. The adherence and process evaluation were assessed. Methods A cluster randomized controlled trial conducted among 15 Spanish schools was developed. Each school was randomized into either an experimental condition (EC) (N=742) or a control condition (CC) (N=505). Finally, 351 participants for the EC and 261 for the CC were included in the analysis (N=612). Baseline assessment took place in January and February 2017. Demographic variables and alcohol use were assessed at baseline. Follow-up assessment of alcohol use took place 4 months later in May and June 2017. Participants were compared according to their randomization group (EC versus CC). After the baseline assessment, participants in the EC started the intervention, which consisted of short stories about BD, in which CT feedback was based on the I-Change Model for behavior change. Participants in the CC group only received the baseline questionnaire. Effects of the intervention were assessed using a three-level mixed logistic regression analysis for BD, HED, and any consumption, and a three-level mixed linear regression analysis for weekly consumption. Results In total, 1247 adolescents participated in the baseline assessment and 612 participated in the follow-up assessment; the attrition rate was 50.92%. The intervention was effective in reducing HED among adolescents; the odds of HED in the CC was nine times that in the experimental condition (P=.04). No effects were found for BD, weekly consumption, and any consumption. Process evaluations revealed that the adolescents were satisfied with the program (68.8%), would use the program again (52.9%), and would recommend it to someone else (62.8%). Females and non-binge drinkers showed better responses in the process evaluation. Conclusions Our intervention was effective regarding HED but not regarding BD, weekly consumption, and any consumption. It may be that limiting alcohol consumption to prevent HED was easier in the Spanish context than it was to carry out further steps, such as reducing other patterns of alcohol consumption. Hence, additional actions are needed to accomplish these latter goals, including community approaches and policy actions aimed at denormalizing alcohol consumption among Spanish adolescents. Trial Registration ClinicalTrials.gov NCT03288896; https://clinicaltrials.gov/ct2/show/NCT03288896 International Registered Report Identifier (IRRID) RR2-10.1186/s12889-018-5346-4

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M44. COGNITIVE REMEDIATION AND PHYSICAL EXERCISE EFFECTS ON NEGATIVE SYMPTOMS AND FUNCTIONALITY IN PATIENTS WITH SCHIZOPHRENIA: A RANDOMIZED CONTROLLED TRIAL

Schizophrenia Bulletin ◽

10.1093/schbul/sbaa030.356 ◽

2020 ◽

Vol 46 (Supplement_1) ◽

pp. S150-S151

Author(s):

Anna Mane ◽

Romina Cortizo ◽

Adelina Abellanas ◽

Elena Belmonte ◽

Alba Toll ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Regression Analysis ◽

Physical Exercise ◽

Multiple Regression Analysis ◽

Multiple Regression ◽

Negative Symptoms ◽

Controlled Trial ◽

Cognitive Remediation ◽

Randomized Controlled

Abstract Background Cognitive and negative symptoms are key determinants in schizophrenia functionality. Cognitive remediation (CR) has shown to improve cognition in patients with schizophrenia but the impact on functionality is still unsatisfactory. On the other hand, an improvement in negative symptoms has also been described with CR and some studies have shown physical exercise (PE) may also improve negative symptoms. The present study sets out to investigate the effects of CR+PE in overall negative symptoms, and more specifically, in the avolition and expression factor, as well as in functionality, in a sample of patients diagnosed with multi-episode schizophrenia. Furthermore, it sets out to investigate determinants of functionality at follow-up. Methods Randomized controlled trial with two groups: CR+PE and CR plus lifestyle promotion (LP) (control group) (www.clinicaltrials.gov NCT 02864576). Participants: Subjects fulfilling DSM-IV-TR criteria for schizophrenia or schizo-affective disorder diagnosis, aged between 25–60 years, with an illness duration >o = 10 years, clinically stable and with low physical activity were included. Each randomly assigned intervention consists of 36 sessions carried out 3-times/week in groups of 4–6 participants of CR+PE or CR+LP. Analyses: Baseline sociodemographic and clinical characteristics were assessed at baseline in both groups. Repeated measures of multiple analysis of variance (MANOVA) was performed for negative symptoms (BNSS total scale and avolition and expression factors) and functionality (GAF score) with group (CR+PE vs CR+LP) as the between-subject factor and time (pre-treatment and post-treatment) as the within-group factor. The main effects of time, group, and time × group were examined. Multiple regression analysis (whole sample) with GAF at follow-up as the dependent variable and avolition, expression and PANSS-P subscale at follow-up, and gender and age as independent variables was also carried out. Results 43 patients were included and randomized. 38 patients completed the study, 19 in each group. There were not statistically significant differences between both groups at baseline. There was a time x grup effect on GAF at follow-up (F=4.25 p= 0.047) and on the avolition factor (F=2.99 p= 0.09), with improvements in favour of the CR+ PE group. Furthermore, GAF at follow-up was only related with the avolition factor in the multiple regression analysis (B= -0.63, t -2.84, p=0.009 (CI -1.09-0.17)). Discussion CR+PE is associated with an improvement in negative symptoms, and more specifically, in the avolition factor, as well as in functionality. This specific improvement in the avolition factor is important, as functionality at follow-up is specifically associated with the avolition factor in our study, in accordance with previous studies. This work is funded by the Instituto de Salud Carlos III-Subdirección General de Evaluación y Fomento de la Investigación, with the Research Project PI15/00453.

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