Psychoeducational manual for treating binge eating disorder (BED) patients: A controlled trial

2011 ◽  
Vol 26 (S2) ◽  
pp. 730-730
Author(s):  
S.C. Stefano ◽  
A.M.R. Devoraes ◽  
A.M.R. Souza ◽  
M.H. Kaio ◽  
S.L. Blay
Keyword(s):  
Controlled Trial ◽  
Randomized Study ◽  
Outpatient Service ◽  
Care Program ◽  
Structured Interview ◽  
Stepped Care ◽  
Psychiatric Evaluation ◽  
Control Group ◽  
Comprehensive Treatment ◽  
Number Of Patients

ObjectiveTo evaluate the efficacy of a psychoeducational manual as first intervention when treating BED.MethodIt was conducted a 8-week controlled trial (before-after) without a control group. Twenty BED patients were enrolled at an outpatient service specialized in eating disorders (PROATA).After being submitted to a psychiatric evaluation and responding to the following instruments: MINI-PLUS, QEWP-R, BES, BDI, HAM-A, SF-36, and BSQ, the subjects signed a consent term and they received explanations about the manual. After eight weeks the patients were re-evaluated by trained examiners.The main outcome criterion was the BED evolution (evaluated through QEWP-R and BES). The secondary criteria were evaluated through the other instruments plus a semi-structured interview.ResultsMost patients presented a slight improvement of BED symptoms, although these symptoms are still present. The secondary criteria show that the most relevant aspect was that the information presented in the manual allowed the patients to acknowledge they had a condition and to see themselves with less guilt and prejudice, making it easier to look for a more comprehensive treatment.ConclusionsThere are indications that using the psychoeducational manual can reduce the symptoms, and that it can be useful in identifying the condition and allowing the patients to look for treatment. Also, since the instrument can be used as part of a stepped-care program, a broader, controlled and randomized study enrolling a larger number of patients must be conducted in order to better clarify the results.

scholarly journals A Collaborative Deprescribing Intervention in a Subacute Medical Outpatient Clinic: A Pilot Randomized Controlled Trial

Metabolites ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. 204
Author(s):  
Anissa Aharaz ◽  
Jens Henning Rasmussen ◽  
Helle Bach Ølgaard McNulty ◽  
Arne Cyron ◽  
Pia Keinicke Fabricius ◽  
...  
Keyword(s):  
Pilot Study ◽  
Controlled Trial ◽  
Inappropriate Medication ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Patient Interviews ◽  
Number Of Patients ◽  
Multimorbid Patients ◽  
And Control

Medication deprescribing is essential to prevent inappropriate medication use in multimorbid patients. However, experience of deprescribing in Danish Subacute Medical Outpatient Clinics (SMOCs) is limited. The objective of our pilot study was to evaluate the feasibility and sustainability of a collaborative deprescribing intervention by a pharmacist and a physician to multimorbid patients in a SMOC. A randomized controlled pilot study was conducted, with phone follow-up at 30 and 365+ days. A senior pharmacist performed a systematic deprescribing intervention using the Screening Tool of Older Persons’ potentially inappropriate Prescriptions (STOPP) criteria, the Danish deprescribing list, and patient interviews. A senior physician received the proposed recommendations and decided which should be implemented. The main outcome was the number of patients having ≥1 medication where deprescribing status was sustained 30 days after inclusion. Out of 76 eligible patients, 72 (95%) were included and 67 (93%) completed the study (57% male; mean age 73 years; mean number of 10 prescribed medications). Nineteen patients (56%) in the intervention group and four (12%) in the control group had ≥1 medication where deprescribing status was sustained 30 days after inclusion (p = 0.015). In total, 37 medications were deprescribed in the intervention group and five in the control group. At 365+ days after inclusion, 97% and 100% of the deprescribed medications were sustained in the intervention and control groups, respectively. The three most frequently deprescribed medication groups were analgesics, cardiovascular, and gastrointestinal medications. In conclusion, a collaborative deprescribing intervention for multimorbid patients was feasible and resulted in sustainable deprescribing of medication in a SMOC.

scholarly journals The Effects of Telemonitoring on Patient Compliance With Self-Management Recommendations and Outcomes of the Innovative Telemonitoring Enhanced Care Program for Chronic Heart Failure: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Hang Ding ◽  
Rajiv Jayasena ◽  
Sheau Huey Chen ◽  
Andrew Maiorana ◽  
Alison Dowling ◽  
...  
Keyword(s):  
Heart Failure ◽  
Randomized Controlled Trial ◽  
Chronic Heart Failure ◽  
Patient Compliance ◽  
Controlled Trial ◽  
Care Program ◽  
Self Management ◽  
Control Group ◽  
Randomized Controlled ◽  
Management Recommendations

BACKGROUND Telemonitoring enables care providers to remotely support outpatients in self-managing chronic heart failure (CHF), but the objective assessment of patient compliance with self-management recommendations has seldom been studied. OBJECTIVE This study aimed to evaluate patient compliance with self-management recommendations of an innovative telemonitoring enhanced care program for CHF (ITEC-CHF). METHODS We conducted a multicenter randomized controlled trial with a 6-month follow-up. The ITEC-CHF program comprised the provision of Bluetooth-enabled scales linked to a call center and nurse care services to assist participants with weight monitoring compliance. Compliance was defined a priori as weighing at least 4 days per week, analyzed objectively from weight recordings on the scales. The intention-to-treat principle was used to perform the analysis. RESULTS A total of 184 participants (141/184, 76.6% male), with a mean age of 70.1 (SD 12.3) years, were randomized to receive either ITEC-CHF (n=91) or usual care (control; n=93), of which 67 ITEC-CHF and 81 control participants completed the intervention. For the compliance criterion of weighing at least 4 days per week, the proportion of compliant participants in the ITEC-CHF group was not significantly higher than that in the control group (ITEC-CHF: 67/91, 74% vs control: 56/91, 60%; <i>P</i>=.06). However, the proportion of ITEC-CHF participants achieving the stricter compliance standard of at least 6 days a week was significantly higher than that in the control group (ITEC-CHF: 41/91, 45% vs control: 23/93, 25%; <i>P</i>=.005). CONCLUSIONS ITEC-CHF improved participant compliance with weight monitoring, although the withdrawal rate was high. Telemonitoring is a promising method for supporting both patients and clinicians in the management of CHF. However, further refinements are required to optimize this model of care. CLINICALTRIAL Australian New Zealand Clinical Trial Registry ACTRN12614000916640; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366691

Effectiveness of Asthma Self-Care Program Through Mobile Line Application (SALA) on Lung Function among Asthma Patients in Angthong Hospital: A Randomized Control Trial

2021 ◽  
Vol 104 (2) ◽  
pp. 264-270
Keyword(s):  
Lung Function ◽  
Usual Care ◽  
Controlled Trial ◽  
Demographic Data ◽  
Intervention Group ◽  
Self Care ◽  
Care Program ◽  
Self Management ◽  
Control Group ◽  
Asthma Patients

Background: Asthma is a disease that causes a lot of suffering. It becomes a hurdle in everyday life. Asthma self-care program through mobile Line application (SALA) might be a good choice to help resolving this problem. Objective: To evaluate effectiveness of SALA program among asthma patients. Materials and Methods: The present study was a randomized controlled trial. The study sample consisted of 62 participants aged between 20 to 60 years with mild to moderate asthma. The study sample were randomly assigned to intervention plus usual care (intervention group, n=31) or usual care (control group, n=31) by computer generated. SALA program was sent to participants once a week for two months through their mobile phone, drug reminder appointment date for four months. The study period was six months. Clinical record form and Questionnaire were adapted to collect the demographic data and lung function via spirometer as FEV₁, FVC, FEV₁/FVC, PEFR, ACS, knowledge, attitude, and self-management. Mini Asthma Quality of Life (QOL) questionnaire was used to collect the data. Intention to treat (ITT), Repeated ANOVA, and General Linear model were statistical technique used to analyze the data. Results: Data from 60 asthma patients were available for analyses. The baseline characteristics of both groups were not significantly different. There were statistically significant mean differences in between the groups at three and six months. The mean difference in the following variables were FEV₁ 13.83 (5.01 to 22.65) FVC, 13.36 (2.62 to 24.09) FEV₁/FVC, 11.65 (4.8 to 18.49), PEFR 9.85 (0.03 to 19.67), ACS 2.45 (0.62 to 4.27), knowledge 2.64 (0.81 to 4.46), and self-management 4.26 (2.00 to 6.52). Conclusion: SALA improved knowledge, self-management, asthma status, and lung function among asthma patients. Keywords: Asthma, Self-care program, Mobile line application

scholarly journals Design and analysis of a clinical trial using previous trials as historical control

2019 ◽  
Vol 16 (5) ◽  
pp. 531-538 ◽  
Author(s):  
David Alan Schoenfeld ◽  
Dianne M Finkelstein ◽  
Eric Macklin ◽  
Neta Zach ◽  
David L Ennist ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Amyotrophic Lateral Sclerosis ◽  
Sample Size ◽  
Standard Error ◽  
Controlled Trial ◽  
Sample Size Calculation ◽  
Control Group ◽  
Controlled Trials ◽  
Number Of Patients ◽  
Lateral Sclerosis

Background/AimsFor single arm trials, a treatment is evaluated by comparing an outcome estimate to historically reported outcome estimates. Such a historically controlled trial is often analyzed as if the estimates from previous trials were known without variation and there is no trial-to-trial variation in their estimands. We develop a test of treatment efficacy and sample size calculation for historically controlled trials that considers these sources of variation.MethodsWe fit a Bayesian hierarchical model, providing a sample from the posterior predictive distribution of the outcome estimand of a new trial, which, along with the standard error of the estimate, can be used to calculate the probability that the estimate exceeds a threshold. We then calculate criteria for statistical significance as a function of the standard error of the new trial and calculate sample size as a function of difference to be detected. We apply these methods to clinical trials for amyotrophic lateral sclerosis using data from the placebo groups of 16 trials.ResultsWe find that when attempting to detect the small to moderate effect sizes usually assumed in amyotrophic lateral sclerosis clinical trials, historically controlled trials would require a greater total number of patients than concurrently controlled trials, and only when an effect size is extraordinarily large is a historically controlled trial a reasonable alternative. We also show that utilizing patient level data for the prognostic covariates can reduce the sample size required for a historically controlled trial.ConclusionThis article quantifies when historically controlled trials would not provide any sample size advantage, despite dispensing with a control group.

scholarly journals Effect of Exercise Program on Fatigue and Depression among Geriatric Patients Undergoing Hemodialysis

2019 ◽  
Vol 8 (2) ◽  
pp. 23
Author(s):  
Soad Hassan Abd Elhameed ◽  
Doaa El Sayed Fadila
Keyword(s):  
Geriatric Patients ◽  
Controlled Trial ◽  
Geriatric Depression Scale ◽  
Depression Scale ◽  
Exercise Program ◽  
Structured Interview ◽  
University Hospital ◽  
Control Group ◽  
Control Groups ◽  
And Control

Background: Fatigue is one of the foremost common complications faced the hemodialysis elderly patients. Fatigue not only impact the daily lives and activities of patients but it conjointly influences their quality of life, which can afterwards result in magnified depression, tiny social interactions and increase dependency on others.Aim: Determine the effect of exercise program on fatigue and depression among geriatric patients undergoing hemodialysis.Design: Randomized controlled trial (pretest post-test) design was used.Setting: The study was carried out in the dialysis units of Mansoura University Hospital and New Mansoura General Hospital.Subjects: A purposive sample of 62 geriatric patients undergoing hemodialysis was selected and randomly allocated into two equal groups, study group (n = 31) and control group (n =31).Tools: Three tools were used; Structured interview questionnaire sheet, Multidimensional Fatigue Inventory Scale and Geriatric Depression Scale Short Form.Results: The mean age of the study and control groups was 63.45±4.49 and 64.7±5.25 respectively. A high statistically significant change in fatigue and depression score (pre and post 2 months) between the study and the control groups was observed (P=0.000). Moreover, a statistically significant relation was observed between fatigue and age of the hemodialysis geriatric patients after implementation of the exercise program (P= 0.002).Conclusion: Implementation of the exercise program proved to be effective in improving the level of fatigue and depression among geriatric patients undergoing hemodialysis in the study group.Recommendation: Encourage geriatric patients undergoing hemodialysis to perform regularly range of motion and relaxation exercises in order to alleviate fatigue and overcome depression.  

An improvement in self-care behaviour in heart failure patients lead to better management of hypertension

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
D.S Sahlin ◽  
S Gerward
Keyword(s):  
Heart Failure ◽  
Mean Arterial Pressure ◽  
Arterial Pressure ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Care ◽  
Control Group ◽  
Chi Square ◽  
Home Based ◽  
Number Of Patients

Abstract Background A common heart failure (HF) aetiology is hypertension (HTN), second only to ischemic heart disease and with a prevalence in the HF community of between 62% and 84%, depending on sex and ejection-fraction. Undertreated HTN leads to worse prognosis and resistant HTN is defined as blood pressure (BP) exceeding 140/90 mmHg, in spite of pharmacological treatment. Since one constituent of self-care behaviour is treatment adherence, we wished to study whether patients exposed to a digital intervention shown to improve self-care behaviour, would also display improved BP control. Methods SMART-HF was a randomized controlled trial, recruiting patients from seven centres in Region Skåne in southern Sweden, where patients in the intervention group (IG) were equipped with a digital home-based tool, designed to enhance self-care behaviour for HF-patients and the control group (CG) were subject to standard care. BP data was registered at baseline and after eight months of intervention and self-care behaviour was measured using the European Heart Failure Self-care Behaviour Scale (EHFScB). We used a Chi-square test to analyse whether there was an inter-group difference of prevalence of resistant HTN or a mean arterial pressure (MAP) outside the recommended range of 60 mmHg &lt; MAP &lt;100 mmHg. Results Out of the 118 patients included in the original analysis, 92 (78%) had complete BP measurements. At baseline there was no difference in self-care behaviour between the groups, with CG: 25 [17.5; 32] and IG: 24.5 [18; 30], p=0.61, and 28% of the CG patients and 24% of the IG population displayed resistant HTN, p=0.73. After eight months of intervention the IG had 21% (or 4.5 points) better self-care behaviour compared to the CG, p=0.014, and the fraction of patients with resistant HTN was 30% for the CG and 11% for the IG, p=0.027. There was also a significant effect on the fraction of patients having a MAP &gt;100 mmHg, with 22% in the CG versus 16% in the IG having MAP &gt;100 mmHg at baseline (p=0.39) and 19% in the CG versus 0% in the IG at follow-up (p=0.002). Conclusions There was a significant improvement in self-care behaviour and also a significant reduction in the number of patients with resistant hypertension and elevated mean arterial pressure after eight months of intervention. Funding Acknowledgement Type of funding source: None

scholarly journals Is Local Anesthetic Infiltration Prior to Intravenous Cannulation Beneficial to Patients?

2013 ◽  
Vol 8 (1) ◽  
pp. 10-13
Author(s):  
Babu Raja Shrestha ◽  
U Shrestha ◽  
A Shrestha ◽  
A Rana
Keyword(s):  
Heart Rate ◽  
Local Anesthetic ◽  
Randomized Study ◽  
Cardiovascular Responses ◽  
Control Group ◽  
Venous Cannulation ◽  
Number Of Patients ◽  
Group A ◽  
Group B ◽  
Local Anesthetic Infiltration

Aims: Intravenous cannulation causes pain, anxiety and frustration in patients along with changes in hemodynamic parameters. Infiltration of local anesthetic lessens the pain of intravenous cannulation. This study was performed to compare cardiovascular responses and verbal rating pain scores in two groups with and without local anesthetic infiltration prior to venous cannulation. Methods: This was a randomized study conducted in 100 elective surgical patients, divided into two study groups with 50 patients in each: group A (Control) and group B (local anesthetic infiltration). Prior to venous cannulation in group B, 0.5 ml of 1% lidocaine was infiltrated at the procedure site at dorsum of the wrist. Patients in group A were cannulated directly without local anesthetic infiltration. The hemodynamic changes pre and post cannulation and verbal pain rating scores were recorded by blind observers in all patients. Results: Demographic values in two groups were similar. Increase in heart rate from baseline value was significant in control group (p < 0.05). Post cannulation heart rate, systolic and diastolic blood pressure were significantly higher in group A compared to group B for the first three minutes (p < 0.05). Amongst higher number of patients in group A, verbal rating pain score was significantly higher. Ninety-four percent of the patients in group B were pain free, comfortable and satisfied with the procedure. Conclusions: Intravenous cannulation can be made pain free with patient satisfaction and hemodynamic stability if carried out with prior local anesthetic infiltration. Nepal Journal of Obstetrics and Gynaecology / Vol 8 / No. 1 / Issue 15 / Jan- June, 2013 / 10-13 DOI: http://dx.doi.org/10.3126/njog.v8i1.8853

Randomized Controlled Trial of a Cognitive Narrative Crisis Intervention for Bereavement in Primary Healthcare

2016 ◽  
Vol 45 (1) ◽  
pp. 85-90 ◽  
Author(s):  
Ana Sofia Andrade ◽  
Margarida Moreira ◽  
Mónica Sá ◽  
Duarte Pacheco ◽  
Vera Almeida ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Traumatic Stress ◽  
Controlled Trial ◽  
Cost Effective ◽  
Structured Interview ◽  
Control Group ◽  
Randomized Controlled ◽  
Demographic Questionnaire ◽  
The Impact ◽  
Experimental Group

Background and Aims: As there are known risks of retraumatization through bereavement crisis interventions, we tailored a new intervention lowering the degree of direct emotional activation. However, we need some evidence on the effects of depression and psychotraumatic symptoms between 1 and 6 months after a loss. Method: We conducted a randomized controlled trial with two groups: control group (n = 18) and experimental group (n = 11) in two assessments (1 and 6 months after loss); both included a semi-structured interview (Socio-Demographic Questionnaire, Beck Depression Inventory and the Impact of Events Scale-Revised–IES-R). The experimental group had a cognitive-narrative program with four sessions: recalling; cognitive and emotional subjectivization; metaphorization; and projecting sessions. Results: Participants in the experimental and control groups have lower levels of depression and traumatic stress 6 months after a loss. Statistically significant results in emotional numbing IES-R sub-scale are observed. Conclusions: A brief narrative-based cost-effective intervention has a positive effect on depression, controlling the traumatic stress and time after a loss.

scholarly journals CLINICAL ASPECTS IN WOMEN WITH MENSTRUAL DYSFUNCTION IN PUBERTY

World Science ◽  
2020 ◽  
Author(s):  
Kovalyshyn O. A.
Keyword(s):  
Reproductive Health ◽  
Treatment Effectiveness ◽  
Reproductive Function ◽  
Clinical Aspects ◽  
Control Group ◽  
Comprehensive Treatment ◽  
Menstrual Dysfunction ◽  
Number Of Patients ◽  
The Social ◽  
Somatic Diseases

The reproductive system is exposed to various adverse factors and harmful effects at all stages of functioning of an organism. Against the background of declining levels of women's reproductive health in recent years, there has been a clear tendency towards an increase in the number of patients with pathology of puberty. The low level of somatic and reproductive health before pregnancy causes a high incidence of complicated labors, which leads to a deterioration in the development of subsequent generations.The purpose of the study. To provide clinical characteristics of women who had menstrual dysfunction in puberty, which were based on the study of clinical and anamnestic data, laboratory and instrumental research methods, analysis of risk factors, clinical course, treatment effectiveness and dispensary observation.Materials and methods. According to the nature of the disfunctions, the main group of women (n = 210) who had menstrual disorders in puberty was divided into 3 subgroups (n = 70): the first - women with primary oligomenorrhea and timely average menarche, the second - with late menarche, the third - with pubertal bleeding. The control group included women (n = 70) with the correct rhythm of menstruation in puberty.Results. The clinical prospective study analyzed the social status of women with reproductive dysfunction in puberty, the frequency and structure of existing concomitant somatic diseases, the duration of the menstrual cycle, the nature of diseases of the female genital organs; the assessment of the comprehensive treatment of revealed disorders, which allowed to obtain a favorable reproductive prognosis. The majority of surveyed women (53.3%) planned a pregnancy, which occurred in 75.9% from among of planning ones.Conclusions. The conduction of clinical and anamnestic analysis of the reproductive function of women with menstrual dysfunction in puberty will increase the effectiveness of the treatment of identified disorders and will allow developing algorithms for management of such women during planning and during pregnancy.

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