Randomized Controlled Trial of Written Information: Effect on Parental Nonconcordance With Occlusion Therapy

2003 ◽  
Vol 4 (1) ◽  
pp. 54-55
Author(s):  
Robert D. Reinecke
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Information Effect ◽  
Occlusion Therapy ◽  
Randomized Controlled ◽  
Written Information

The effect of written information and counselling by an advanced practice nurse on resilience in women with vulvar neoplasia during six months after surgical treatment and the influence of social support, recurrence, and age: A secondary analysis of a multicenter randomized controlled trial, WOMAN-PRO-II

2020 ◽  
Author(s):  
Sabine Kofler ◽  
Andrea Kobleder ◽  
Stefan Ott ◽  
Beate Senn
Keyword(s):  
Randomized Controlled Trial ◽  
Surgical Treatment ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Practice Nurse ◽  
Controlled Trial ◽  
Advanced Practice ◽  
Advanced Practice Nurse ◽  
Randomized Controlled ◽  
Written Information

Abstract Background: Women with vulvar neoplasia often complain about physical and psychological distress after surgical treatment. Lack of information and support can influence resilience. Whether an information-related intervention through an advanced practice nurse supports resilience and which other factors affect resilience in women with vulvar neoplasia has never been investigated. Methods: The aims of this study were (a) to analyse whether counselling based on the WOMAN-PRO II program causes a significant improvement in the resilience scores of women with vulvar neoplasia compared to written information and (b) to identify the potential predictors of resilience. A randomized controlled trial was conducted in women with vulvar neoplasia (n = 49) six months after surgical treatment in four Swiss hospitals and one Austrian hospital. Analyses of resilience and its predictors were performed using a linear mixed model. Results: Thirty-six women (intervention I, n = 8; intervention II, n = 28) completed the randomized controlled trial. In total, 13 women (26.5%) dropped out of the trial. The resilience score did not differ significantly between the two interventions three and six months after randomisation (p = 0.759). Age (b = .04, p = 0.001), social support (b = .28, p = 0.009), counselling time (b = .03, p = 0.018) and local recurrence (b = −.56, p = 0.009) were identified as significant predictors of resilience in the linear mixed model analyses. Conclusion: The results indicate that the WOMAN-PRO II program as single intervention does not cause a significant change in the resilience scores of women with vulvar neoplasia six months after surgery. Predictors that promote or minimise resilience have been identified and should be considered when developing resilience programs for women with vulvar neoplasia. A repetition of the study with a larger sample size is recommended.

scholarly journals The effect of written information and counseling by an APN on resilience in women with vulvar neoplasia during six months after surgical treatment and the influence of social support, recurrence, and age: A secondary analysis of a multicenter randomized controlled trial, WOMAN-PRO-II

2019 ◽  
Author(s):  
Sabine Kofler ◽  
Andrea Kobleder ◽  
Stefan Ott ◽  
Beate Senn
Keyword(s):  
Social Support ◽  
Randomized Controlled Trial ◽  
Surgical Treatment ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Advanced Practice ◽  
Randomized Controlled ◽  
Written Information ◽  
Lack Of Information ◽  
Multicenter Randomized Controlled Trial

Abstract Background Woman with vulvar neoplasia complain after surgical treatment often about physical and psychological distress. Lack of information and support can influence resilience. Whether an information-related intervention through an advanced practice nurse support resilience and which other factors have an influence on resilience in women with vulvar neoplasia has never been investigated.Methods The aim of this study were (a) to analyse whether counseling based on the WOMAN-PRO-II program compared to written information creates a significant improvement in resilience scores of women with vulvar neoplasia and (b) to identify potential predictors for resilience. A randomized controlled trial was carried out in women with vulvar neoplasia (N = 49) six months after a surgical treatment in four Swiss hospitals and one Austrian hospital. Analyses of resilience and its predictors were performed using a linear mixed model.Results The resilience score did not differ significantly between the two intervention three and six months after randomisation (p=0.759). As significant predictors of resilience, age (b=.04, p=0.001), social support (b=.28, p=0.009), counseling time (b=.03, p=0.018), and local recurrence (b=-.56, p=0.009) could be identified in linear mixed models analyses.Conclusion To promote resilience in women with vulvar neoplasia, the WOMAN-PRO II Program should be further developed. Particularly, social support should be extended, e.g. in form of more frequent consultations. The interrelation between recurrence and resilience needs to be further investigated to provide specific counseling for women with recurrence.

The Effects of a Multicomponent Dyadic Intervention With Physical Exercise on the Cognitive Functioning of People With Dementia: A Randomized Controlled Trial

2017 ◽  
Vol 25 (4) ◽  
pp. 539-552 ◽  
Author(s):  
Anna-Eva Prick ◽  
Jacomine de Lange ◽  
Erik Scherder ◽  
Jos Twisk ◽  
Anne Margriet Pot
Keyword(s):  
Randomized Controlled Trial ◽  
Physical Exercise ◽  
Cognitive Functioning ◽  
Controlled Trial ◽  
Care Facility ◽  
Randomized Controlled ◽  
Written Information ◽  
Phone Calls ◽  
People With Dementia ◽  
Home Based

The objective was to evaluate the effects of a multicomponent dyadic intervention on the cognitive functioning of people with dementia living at home in a randomized controlled trial. People with dementia and their family caregivers (n = 111) were randomly assigned to 8 home-based sessions including physical exercise and support or a minimal intervention consisting of monthly written information bulletins and monthly phone calls. Memory, executive functioning (EF), and attention were assessed at baseline, and after 3 (postmeasurement) and 6 months (follow-up). Data were analyzed by using generalized estimating equations (GEE). A small, significant effect was found on attention. No effects were found on memory and EF. Finding only a small significant effect might be explained by the ineffectiveness of the intervention, but also by moderate treatment adherence or a lack of room for improvement because half of the people with dementia were already receiving care in a day care facility.

Treatment Fidelity Procedures for an Aphasia Intervention Within a Randomized Controlled Trial: Design, Feasibility, and Results

2020 ◽  
Vol 29 (1S) ◽  
pp. 412-424
Author(s):  
Elissa L. Conlon ◽  
Emily J. Braun ◽  
Edna M. Babbitt ◽  
Leora R. Cherney
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Treatment Fidelity ◽  
Protocol Adherence ◽  
Study Condition ◽  
Randomized Controlled ◽  
Aphasia Therapy ◽  
Percent Accuracy ◽  
Over Time

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.

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