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The PAADRN study: a design for a randomized controlled practical clinical trial to improve bone health.

ABSTRACT: To describe the rationale and design of an NIH funded randomized controlled trial: the Patient Activation after DXA Result Notification (PAADRN) study. The aim of this trial is to evaluate the effect that a direct mailing of Dual-Energy X-ray Absorptiometry (DXA) results from bone density testing centers to patients will have on patients' knowledge, treatment and self-efficacy.We will enroll approximately 7500 patients presenting for DXA at three study sites, the University of Iowa, the University of Alabama at Birmingham, and Kaiser Permanente of Atlanta, Georgia. We will randomize providers (and their respective patients) to either the intervention arm or usual care. Patients randomized to the intervention group will receive a letter with their DXA results and an educational brochure, while those randomized to usual care will receive their DXA results according to standard practice. The seven discrete outcomes are changes from baseline to 12-weeks and/or 52-weeks post-DXA in: (1) guideline concordant pharmacologic and non-pharmacologic therapy; (2) knowledge of DXA results; (3) osteoporosis-specific knowledge; (4) general health-related quality of life; (5) satisfaction with bone-related health care, (6) patient activation; and, (7) osteoporosis-specific self-efficacy.This trial will offer evidence of the impact of a novel approach-direct-to-patient mailing of test results-to improve patient activation in their bone health care. The results will inform clinical practice for the communication of DXA and other test results.

SUBMITTER: Edmonds SW

PROVIDER: S-EPMC3525745 | biostudies-other | 2013 Jan

REPOSITORIES: biostudies-other

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The PAADRN study: a design for a randomized controlled practical clinical trial to improve bone health.

Edmonds Stephanie W SW Wolinsky Fredric D FD Christensen Alan J AJ Lu Xin X Jones Michael P MP Roblin Douglas W DW Saag Kenneth G KG Cram Peter P

Contemporary clinical trials 20121017 1

<h4>Introduction</h4>To describe the rationale and design of an NIH funded randomized controlled trial: the Patient Activation after DXA Result Notification (PAADRN) study. The aim of this trial is to evaluate the effect that a direct mailing of Dual-Energy X-ray Absorptiometry (DXA) results from bone density testing centers to patients will have on patients' knowledge, treatment and self-efficacy.<h4>Methods</h4>We will enroll approximately 7500 patients presenting for DXA at three study sites, ...[more]

PMID: 23085132

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Project description:BackgroundDisadvantaged populations face many barriers to cancer care, including limited support in navigating through the complexities of the healthcare system. Family members play an integral role in caring for patients and provide valuable care coordination; however, the effect of family navigators on adherence to cancer screening has not previously been evaluated. Training and evaluating trusted family members and other support persons may improve cancer outcomes for vulnerable patients.MethodsGuided by principles of community based participatory research (CBPR), "Evaluating Coaches of Older Adults for Cancer Care and Healthy Behaviors (COACH)" is a community-based randomized controlled trial to assess the effectiveness of a trained participant-designated coach (support person or care giver) in navigating cancer-screening for older African American adults, 50-74 years old. Participants are randomly assigned as dyads (participant+coach pair) to receiving either printed educational materials only (PEM--control group) or educational materials plus coach training (COACH--intervention group). We defined a coach as family member, friend, or other lay support person designated by the older adult. The coach training is designed as a one-time, 35- to 40-minute training consisting of: 1) a didactic session that covers the role of the coach, basic facts about colorectal, breast and cervical cancers (including risk factors, signs and symptoms and screening modalities), engaging the healthcare provider in cancer screening, insurance coverage for screening, and related healthcare issues, 2) three video skits addressing misconceptions about and planning for cancer screening, and 3) an interactive role-play session with the trainer to reinforce and practice strategies for encouraging the participant to get screened. The primary study outcome is the difference in the proportion of participants completing at least one of the recommended screenings (for breast, cervix or colorectal cancer) between the control and intervention groups.DiscussionBuilding on trusted patient contacts to encourage cancer screening, COACH is a highly sustainable intervention in a high-risk population. It has the potential to minimize the effect of mistrust of the medical establishment on screening behaviors by mobilizing participants' existing support networks. If effective, the intervention could have a high impact on health care disparities research across multiple diseases.Trial registrationClinicalTrials.gov ( NCT01613430 ). Registered June 5, 2012.

Project description:Few randomized controlled trials (RCTs) report interventions targeting improvement of frailty status as an outcome.This RCT enrolled 117 older adults (65-79?years of age) in Toufen, Taiwan who scored 3-6 on The Chinese Canadian Study of Health and Aging Clinical Frailty Scale Telephone Version and then score ?1 on the Cardiovascular Health Study Phenotypic Classification of Frailty (CHS_PCF). With a two by two factorial design, subjects were randomly assigned to interventions (Exercise and nutrition, EN, n?=?55 or problem solving therapy, PST, n?=?57) or controls (non-EN, n?=?62 or non-PST, n?=?60). Educational booklets were provided to all. EN group subjects received nutrition consultation and a thrice-weekly exercise-training program while PST group subjects received 6 sessions in 3?month. Subjects were followed at 3, 6, and 12?months. Primary outcome was improvement of the CHS_PCF by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline assessments. One hundred and one completed final assessments. Intention-to-treat analysis with the generalized estimating equation model was applied with adjustment for time and treatment-by-time interactions.Mean age was 71.4?±?3.7?years, with 59% females. Baseline characteristic were generally comparable between groups. EN group subjects had a higher improvement rate on the primary outcome than non-EN group subjects (45% vs 27%, adjusted p?=?0.008) at 3?months, but not 6 or 12?months. They also had more increase of serum 25(OH) vitamin D level (4.9?±?7.7 vs 1.2?±?5.4, p?=?0.006) and lower percentage of osteopenia (74% vs 89% p?=?0.042) at 12?months. PST group subjects had better improvement (2.7?±?6.1 vs 0.2?±?6.7, p?=?0.035, 6-month) and less deterioration (-3.5?±?9.7 vs -7.1?±?8.7, p?=?0.036, 12-month) of dominant leg extension power than non-PST subjects. Some secondary outcomes were also improved in control groups (non-EN or non-PST). No adverse effects were reported.The three-month EN intervention resulted in short-term (3-month) frailty status improvement and long-term effect on bone mineral density and serum vitamin D (12-month) among Taiwanese community-dwelling elders. The effect of PST was less pronounced.ClinicalTrials.gov: EC0970301

Project description:Background:Conditioning of physiological responses can be achieved by repeatedly pairing a previously neutral conditioned stimulus with the administration of a pharmacologically salient unconditioned stimulus. This type of conditioning has been effective for specific immune and endocrine responses, but results with regard to conditioning of cortisol, a key stress-regulatory parameter, are currently unclear. This paper describes a pharmacological conditioning design, optimized for the examination of effects of cortisol conditioning under both basal conditions and in response to stress. Methods:A double-blind randomized controlled conditioning paradigm aimed at conditioning of cortisol is conducted in 48 healthy female volunteers. During the acquisition phase, a gustatory stimulus (conditioned stimulus) is paired with hydrocortisone (100?mg, capsulated, unconditioned stimulus) three times before being administered together with placebo during three evocation sessions. To investigate possible effects of cortisol conditioning in response to stress, participants are exposed to the Trier Social Stress Test during the third evocation session. Primary outcome measure of this study is the mean area under the curve of salivary cortisol during the first two evocation sessions. As secondary outcomes, self-reported affect and stress as well as alpha-amylase are investigated. A pilot study was conducted to ensure that this design is feasible to be used in a larger study. Discussion:This study design provides an innovative opportunity to examine the conditioning of cortisol under basal conditions and in response to stress. Also, the possible effect of cortisol conditioning on secondary outcomes of self-reported affect and alpha-amylase can be investigated. If cortisol could successfully be conditioned, this would be of conceptual relevance, showing that hypothalamic pituitary adrenal (HPA) axis regulation can be influenced by associative learning processes. Eventually, this could also have important clinical implications for understanding and treating stress-related disorders in which HPA axis dysregulation might play a role. Trial registration:Nederlands Trial Register, NTR4651. Registered on 29 July 2014.

Project description:Following esophagectomy, esophageal cancer patients experience a clinically relevant deterioration of health-related quality of life, both on the short- and long-term. With the currently growing number of esophageal cancer survivors, the burden of disease- and treatment-related complaints and symptoms becomes more relevant. This emphasizes the need for interventions aimed at improving quality of life. Beneficial effects of post-operative physical exercise have been reported in several cancer types, but so far comparable evidence in esophageal cancer patients is lacking. The aim of this study is to investigate effects of physical exercise on health-related quality of life in esophageal cancer patients following surgery.The Physical ExeRcise Following Esophageal Cancer Treatment (PERFECT) study is a multicenter randomized controlled trial including 150 esophageal cancer patients after surgery with curative intent. Patients are randomly allocated to an exercise group or usual care group. The exercise group participates in a 12-week combined aerobic and resistance exercise program, supervised by a physiotherapist near the patient's home-address. In addition, participants in the exercise group are requested to be physically active for at least 30 min per day, every day of the week. Participants allocated to the usual care group are asked to maintain their habitual physical activity pattern. The primary outcome is health-related quality of life (EORTC-QLQ-C30). Secondary outcomes include esophageal cancer specific quality of life, fatigue, anxiety and depression, sleep quality, work-related factors, cardiorespiratory fitness (VO2peak), muscle strength, physical activity, malnutrition risk, anthropometry, blood markers, recurrence of disease and survival. All questionnaire outcomes, diaries and accelerometers are assessed at baseline, post-intervention (12 weeks post-baseline) and 24 weeks post-baseline. Physical fitness, anthropometry and blood markers are assessed at baseline and post-intervention. In addition, adherence and safety are monitored throughout the exercise program.This randomized controlled trial investigates effects of physical exercise versus usual care in esophageal cancer patients after surgery. As the design of the exercise program closely resembles daily practice, this study can contribute both to evidence on effects of exercise in esophageal cancer patients, and to potential implementation strategies.Trial registration:Netherlands Trial Registry NTR5045 Date of trial registration: January 19th, 2015 Date and version study protocol: February 2017, version 1.

Project description:BackgroundMobile health, mHealth is recognized as a strategy to improve lifestyle behaviors. Research targeting specific lifestyle behaviors has shown that interventions using smartphones can be effective. However, few studies have evaluated solutions with multicomponent interventions, tailoring the intervention to the specific needs of the participant using a combination of mHealth and conventional treatment. To accomplish this, we developed Health Integrator, an mHealth platform with services and offers in the areas of diet, physical activity, sleeping habits, stress, alcohol and tobacco use. In the system, the user selects an area of intervention together with a health coach and set weekly goals. This study protocol presents the design and methodology of the Health Integrator Study, a randomized controlled trial to promote improved lifestyle behaviors.MethodsA three-arm parallel randomized controlled trial (1:1:1) is conducted in the Stockholm County, Sweden. In total, 209 employees at a four different companies representing both white and blue collar workers, have been recruited. Participants are randomized to either a control group or to one of two intervention groups receiving a 3-month lifestyle behavior change program including either 1) use of Health Integrator and monthly health coaching sessions or 2) only Health Integrator. At baseline and follow-up after 3- and 6-months, all participants answer questionnaires assessing lifestyle behaviors and quality of life. At baseline and the 3-month follow-up (end of intervention period), weight, height, waist circumference and blood pressure are measured, and all participants wear an Actigraph accelerometer for 7 days to assess physical activity. Blood lipid profile and HbA1c are measured among all participants at baseline. If baseline measures fall outside the normal range, a second measurement is done after 3 months.DiscussionThe Health Integrator Intervention Study will evaluate if a personalized intervention combining mHealth and conventional programs for lifestyle change, with or without additional health coach sessions, can improve lifestyle behaviors and quality of life. Based on the results from this trial, Health Integrator can easily be implemented within a broad public.Trial registrationClinicalTrials.gov Identifier: NCT03579342 . Retrospectively registered, first submitted May 8, 2018.

Project description:BackgroundScreening colonoscopy has been associated with reduced mortality from colorectal cancer by means of early detection and timely treatment. However, visualization during colonoscopy is often impaired since the colon is naturally prone to peristalsis and spasm. There is evidence to suggest benefit of topical peppermint oil in causing smooth muscle relaxation, thereby decreasing peristalsis. The aim of our study was to determine if peppermint oil helps reduce colonic spasticity so as to allow for better visualization during screening colonoscopy.MethodsWe performed a randomized controlled, double-blinded, clinical trial where patients undergoing screening colonoscopy were assigned to receive either peppermint oil or placebo. Once cecum was reached, 50 mL of either solution was directly injected via the working channel of the colonoscope. Colonic peristalsis, spasticity and bowel visibility were documented. Bowel preparation quality, withdrawal time and adenoma detection rate (ADR) were also assessed. Continuous variables were analyzed using t-test or Wilcoxon rank-sum test while categorical variables were compared using the two-way Chi-square test.ResultsForty-eight patients were included, of whom 24 patients received peppermint oil and 24 received placebo. Mean Boston bowel preparation score (BBPS) was excellent for both groups (8 points vs. 7.9 points; P = 0.98). Both mean total colonoscopy time (17.8 min vs. 21.9 min; P = 0.07) and mean cecal intubation time (7.2 min vs. 10.3 min; P = 0.04) were shorter with peppermint oil as compared to placebo. Complete absence of bowel spasticity was observed among 58.3% patients in the peppermint oil group as compared to 45.8% patients in the placebo group (P = 0.05). More than 75% of bowel was visualized in 83% of patients in both groups (P = 0.56). Mean ADR was higher in the peppermint group as compared to the placebo group (45.8% vs. 37.5%; P = 0.56).ConclusionOur study suggests that topical peppermint oil reduces bowel wall spasticity, which could lead to better visualization of the bowel during screening colonoscopy. Although use of peppermint oil was associated with better ADRs, these results did not achieve statistical significance. Larger sample size and use of alternative methods of peppermint oil administration allowing for more absorption time may establish stronger results.

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The PAADRN study: a design for a randomized controlled practical clinical trial to improve bone health.

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The PAADRN study: a design for a randomized controlled practical clinical trial to improve bone health.

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