Protocol For Feasibility Study Research Articles

The Functional Fitness MOT Test Battery for Older Adults: Protocol for a Mixed-Method Feasibility Study.

BackgroundIncreasing physical activity (PA) brings many health benefits, but engaging people in higher levels of PA after their 60s is not straightforward. The Functional Fitness MOT (FFMOT) is a new approach which aims to raise awareness about the importance of components of fitness (strength, balance, flexibility), highlight benefits of PA, engages older people in health behavior change discussions, and directs them to local activity resources. This battery of tests combined with a brief motivational interview has not been tested in terms of feasibility or effectiveness.ObjectiveTo assess whether the FFMOT, provided in a health care setting, is appealing to older patients of a community physiotherapy service and to understand the views and perceptions of the older people undergoing the FFMOT regarding the intervention, as well as the views of the physiotherapy staff delivering the intervention. Secondary aims are to assess the feasibility of carrying out a phase 2 pilot randomized controlled trial of the FFMOT, in the context of a community physiotherapy service, by establishing whether enough patients can be recruited and retained in the study, and enough outcome data can be generated.MethodsA mixed-methods feasibility study will be conducted in two physiotherapy outpatient clinics in the United Kingdom. A total of 30 physically inactive, medically stable older adults over the age of 60 will be provided with an individual FFMOT, comprising a set of six standardized, validated, age-appropriate tests aimed at raising awareness of the different components of fitness. The results of these tests will be used to provide the participants with feedback on performance in comparison to sex and age-referenced norms. This will be followed by tailored advice on how to become more active and improve fitness, including advice on local opportunities to be more active. Subsequently, participants will be invited to attend a focus group to discuss barriers and motivators to being more active, health behavior change, and the scope for individuals to improve their PA levels. To inform the design of a future trial, descriptive (eg, recruitment and retention rates), quantitative (Community Healthy Activities Model Program for Seniors; CHAMPS physical activity questionnaire), and qualitative data (focus group discussions, semi-structured staff interviews) will be collected.ResultsRecruitment and enrolment for the trial started in September 2015. Follow-up will be completed in June 2016. Results are expected to be available at the end of 2016.DiscussionAllied health professionals play a key role in encouraging older adults to increase their PA, but with little evidence on how best to do this within their clinical practice. The purpose of this feasibility study is to examine the introduction of a new service: The FFMOT. The views and perceptions of the older people undergoing the FFMOT and relating to its delivery in clinical practice will be explored. Data, which will inform the feasibility of a randomized controlled trial of effectiveness of the FFMOT in promoting improved PA, will be reported.Trial RegistrationInternational Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN38950042; http://www.isrctn.com/ISRCTN38950042

Describing the characteristics, treatment pathways, outcomes, and costs of people with persistent noncancer pain managed by community pain clinics and generating an indicative estimate of cost-effectiveness: feasibility study protocol.

BackgroundLow back pain (LBP) and fibromyalgia (FM), also known as chronic widespread pain (CWP), are highly prevalent chronic painful conditions that have substantial impact on patients, health care systems, and society. Diagnosis is complex and management strategies are associated with various levels of evidence for effectiveness and cost-effectiveness. Multidisciplinary pain services have been shown to be effective in some settings and therefore are recommended by clinical practice guidelines as a rational treatment option to manage these patients. Knowing that these services are resource intensive, evidence is needed to demonstrate their cost-effectiveness. This study aims to describe the management of patients with LBP and FM in two community pain clinics to derive an indicative estimate of cost-effectiveness compared with standard practice.MethodsThis is a prospective observational multicenter study, using patient-level data. The data from this study will be combined with modelling of the long-term economic impact of community pain clinics in treating people with LBP and FM. Newly referred patients with LBP and FM who provide written consent will be included. We will collect data on functional disability, pain intensity, quality of life, and health resource utilization. Follow-up data at the 3- and 6-month points will be collected by patient-completed questionnaires and health care contact diaries. Health care resource use from diaries will be compared with patient electronic records to assess the agreement between these recording methods. Patient cohort characteristics, treatment pathways, resource use, and outcomes derived from this study will be integrated in a decision analysis model to assess the cost-effectiveness of community pain clinics compared with standard care. This feasibility study will address key methodological issues such as sample estimates and retention rate to inform the design of a future randomized controlled trial.

TechCare: mobile assessment and therapy for psychosis - an intervention for clients in the Early Intervention Service: A feasibility study protocol.

Objectives:Technological advances in healthcare have shown promise when delivering interventions for mental health problems such as psychosis. The aim of this project is to develop a mobile phone intervention for people with psychosis and to conduct a feasibility study of the TechCare App.Methods:The TechCare App will assess participant’s symptoms and respond with a personalised guided self-help-based psychological intervention with the aim of exploring feasibility and acceptability. The project will recruit 16 service users and 8–10 health professionals from the Lancashire Care NHS Foundation Trust Early Intervention Service.Results:In strand 1 of the study, we will invite people to discuss their experience of psychosis and give their opinions on the existing evidence-based treatment (cognitive behavioural therapy) and how the mobile app can be developed. In strand 2, we will complete a test run with a small number of participants (n = 4) to refine the mobile intervention (TechCare). Finally, in strand 3 of the study, the TechCare App will be examined in a feasibility study with 12 participants.Conclusion:It has been suggested that there is a need for a rapid increase in the efforts to develop the evidence base for the clinical effectiveness of digital technologies, considering mHealth research can potentially be helpful in addressing the demand on mental health services globally.

Oxfordshire Women and Their Children's Health (OxWATCH): protocol for a prospective cohort feasibility study

IntroductionSome specific pregnancy disorders are known to be associated with increased incidence of long-term maternal ill health (eg, gestational diabetes with late onset type 2 diabetes; pre-eclampsia with arterial disease)....

Home-based neurologic music therapy for upper limb rehabilitation with stroke patients at community rehabilitation stage-a feasibility study protocol.

Background: Impairment of upper limb function following stroke is more common than lower limb impairment and is also more resistant to treatment. Several lab-based studies with stroke patients have produced statistically significant gains in upper limb function when using musical instrument playing and techniques where rhythm acts as an external time-keeper for the priming and timing of upper limb movements.Methods: For this feasibility study a small sample size of 14 participants (3–60 months post stroke) has been determined through clinical discussion between the researcher and study host in order to test for management, feasibility and effects, before planning a larger trial determined through power analysis. A cross-over design with five repeated measures will be used, whereby participants will be randomized into either a treatment (n = 7) or wait list control (n = 7) group. Intervention will take place twice weekly over 6 weeks. The ARAT and 9HPT will be used to measure for quantitative gains in arm function and finger dexterity, pre/post treatment interviews will serve to investigate treatment compliance and tolerance. A lab based EEG case comparison study will be undertaken to explore audio-motor coupling, brain connectivity and neural reorganization with this intervention, as evidenced in similar studies.Discussion: Before evaluating the effectiveness of a home-based intervention in a larger scale study, it is important to assess whether implementation of the trial methodology is feasible. This study investigates the feasibility, efficacy and patient experience of a music therapy treatment protocol comprising a chart of 12 different instrumental exercises and variations, which aims at promoting measurable changes in upper limb function in hemiparetic stroke patients. The study proposes to examine several new aspects including home-based treatment and dosage, and will provide data on recruitment, adherence and variability of outcomes.

Measuring the implementation of a group-based Lifestyle-integrated Functional Exercise (Mi-LiFE) intervention delivered in primary care for older adults aged 75 years or older: a pilot feasibility study protocol.

BackgroundDeclines in function and quality of life, and an increased risk of cardiovascular events, falls, and fractures occur with aging and may be amenable to exercise intervention. Primary care is an ideal setting for identifying older adults in need of exercise intervention. However, a cost-effective, generalizable model of chronic disease management using exercise in a real-world setting remains elusive. Our objective is to measure the feasibility, potential effectiveness, and implementation of an evidence-based Lifestyle-integrated Functional strength and balance Exercise (LiFE) intervention adapted as a group-based format (Mi-LiFE) for primary care to promote increased physical activity levels in older adults aged 75 years or older. We hypothesize that the intervention will be feasible without modification if ≥30 individuals are recruited over 6 months, ≥75 % of our sample is retained, and ≥50 % of our sample complete exercises ≥3 days per week.Methods/designA pre-post pilot study design will be used to evaluate feasibility, potential effectiveness, and implementation outcomes over a 6-month period in physically inactive older adults ≥75 years recruited from a local family health team practice. The reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework will be applied to evaluate the public health effects of the intervention including outcomes both at the individual and organizational levels. A physical therapist will teach participants how to integrate strength and balance activities into their daily lives over one individual and four group-based sessions, and two phone calls. Assessments will be completed at baseline and 6 months. Feasibility outcomes include recruitment over 6 months, retention at follow-up, and adherence measured by activity diaries. Change in patient-centered and implementation outcomes that will be evaluated include physical activity levels using accelerometers and International Physical Activity Questionnaire, physical performance using short physical performance battery, quality of life using EQ5D questionnaire, falls and harms using daily calendar diaries and self-report, fidelity using descriptive feedback, barriers and facilitators to implementation using thematic content analysis, and process outcomes.DiscussionThe feasibility and implementation of the Mi-LiFE intervention in primary care for older adults will be evaluated, as well as the effects of the intervention on secondary outcomes. If the intervention appears feasible, we will use the resultant information to design a larger trial.Trial registrationClinicalTrials.gov: NCTO2266225Electronic supplementary materialThe online version of this article (doi:10.1186/s40814-015-0016-0) contains supplementary material, which is available to authorized users.

An integrated web-based mental health intervention of assessment-referral-care to reduce stress, anxiety, and depression in hospitalized pregnant women with medically high-risk pregnancies: a feasibility study protocol of hospital-based implementation.

BackgroundAt prevalence rates of up to 40%, rates of depression and anxiety among women with medically complex pregnancies are 3 times greater than those in community-based samples of pregnant women. However, mental health care is not a component of routine hospital-based antenatal care for medically high-risk pregnant women.ObjectiveThe purpose of this study is to evaluate the effectiveness and feasibility of the hospital-based implementation of a Web-based integrated mental health intervention comprising psychosocial assessment, referral, and cognitive behavioral therapy (CBT) for antenatal inpatients.MethodsThis study is a quasi-experimental design. Pregnant women are eligible to participate if they are (1) <37 weeks gestation, (2) admitted to the antenatal inpatient unit for >72 hours, (3) able to speak and read English or be willing to use a translation service to assist with completion of the questionnaires and intervention, (4) able to complete follow-up email questionnaires, (5) >16 years of age, and (6) not actively suicidal. Women admitted to the unit for induction (eg, <72-hour length of stay) are excluded. A minimum sample of 54 women will be recruited from the antenatal high-risk unit of a large, urban tertiary care hospital. All women will complete a Web-based psychosocial assessment and 6 Web-based CBT modules. Results of the psychosocial assessment will be used by a Web-based clinical decision support system to generate a clinical risk score and clinician prompts to provide recommendations for the best treatment and referral options. The primary outcome is self-reported prenatal depression, anxiety, and stress symptoms at 6-8 weeks postrecruitment. Secondary outcomes are postpartum depression, anxiety, and stress symptoms; self-efficacy; mastery; self-esteem; sleep; relationship quality; coping; resilience; Apgar score; gestational age; birth weight; maternal-infant attachment; infant behavior and development; parenting stress/competence at 3-months postpartum; and intervention cost-effectiveness, efficiency, feasibility, and acceptability. All women will complete email questionnaires at 6-8 weeks postrecruitment and 3-months postpartum. Qualitative interviews with 10-15 health care providers and 15-30 women will provide data on feasibility and acceptability of the intervention.ResultsThe study was funded in September, 2014 and ethics was approved in November, 2014. Subject recruitment will begin January, 2015 and results are expected in December, 2015. Results of this study will determine (1) the effectiveness of an integrated Web-based prenatal mental health intervention on maternal and infant outcomes and (2) the feasibility of implementation of the intervention on a high-risk antenatal unit.ConclusionsThis study will provide evidence and guidance regarding the implementation of a Web-based mental health program into routine hospital-based care for women with medically high-risk pregnancies.

Developing and testing a mobile application programme to support self-management in patients with stable angina: a feasibility study protocol.

This study aims to develop and test the feasibility of a 12-week Mobile Application Programme (M.A.P.) to support self-management in cardiac patients with stable angina. A Mobile Application Programme will be developed by the study team. A pilot randomized controlled trial will be adopted to examine the feasibility and potential effectiveness of the M.A.P.. A convenience sample of 40 stable angina patients recruited from the National University Heart Centre will be randomly assigned either to the 12-week M.A.P. intervention group or the control group. Data will be collected at baseline, at the 4th and 12th week of the programme. At the end of the intervention period, a process evaluation will be conducted to further assess the acceptability, usability, strengths and weaknesses of the M.A.P. intervention based on the participants' perspectives. All quantitative data obtained will be analysed using IBM SPSS 21.0, while content analysis will be used for qualitative datasets.

Study of Optimal Replacement of Thyroxine in the ElDerly (SORTED): protocol for a mixed methods feasibility study to assess the clinical utility of lower dose thyroxine in elderly hypothyroid patients: study protocol for a randomized controlled trial.

BackgroundThe population of the UK is ageing. There is compelling evidence that thyroid stimulating hormone distribution levels increase with age. Currently, in UK clinical practice elderly hypothyroid patients are treated with levothyroxine to lower their thyroid stimulating hormone levels to a standard non-age-related range. Evidence suggests that mortality is negatively associated with thyroid stimulating hormone levels. We report the protocol of a feasibility study working towards a full-scale randomized controlled trial to test whether lower dose levothyroxine has beneficial cardiovascular outcomes in the oldest old.Methods/designSORTED is a mixed methods study with three components:SORTED A: A feasibility study of a dual-center single-blinded randomized controlled trial of elderly hypothyroid patients currently treated with levothyroxine.Setting: Patients will be recruited from 20 general practices and two hospital trust endocrine units in Northumberland, Tyne and Wear.Participants: Target recruitment of 50 elderly hypothyroid patients currently treated with levothyroxine, identified in both primary and secondary care settings.Intervention: Reduced dose of levothyroxine to achieve an elevated serum thyroid stimulating hormone (target range 4.1 to 8.0 mU/L) versus standard levothyroxine replacement (target range 0.4 to 4.0 mU/L).Randomization: Using random permuted blocks, in a ratio of 1:1, randomization will be carried out by Newcastle Clinical Trials Unit.Outcomes: Study feasibility (recruitment and retention rates and medication compliance), acceptability of the trial design, assessment of mobility and falls risk, and change in cardiovascular risk factors.SORTED B: Qualitative study using in-depth interviews to understand patients’ willingness to take part in a randomized controlled trial and participants’ experience of the intervention.SORTED C: Retrospective cohort study of 400 treated hypothyroid patients aged 80 years or over registered in 2008 in primary care practices, studying their 4-year cardiovascular outcomes to inform the power of SORTED II.DiscussionThis is a study to evaluate the feasibility of conducting a randomized controlled trial in elderly hypothyroid patients in general practice and hospital settings. The results will inform the design of the definitive SORTED II trial to evaluate the effects of lower dose thyroxine in elderly hypothyroid patients.Trial registrationCurrent Controlled Trials http://ISRCTN16043724

AHA Science Advisory: Lyon Diet Heart Study. Benefits of a Mediterranean-style, National Cholesterol Education Program/American Heart Association Step I Dietary Pattern on Cardiovascular Disease.

Diet is a cornerstone of cardiovascular disease (CVD) prevention and treatment efforts. Step I and Step II diets are widely recommended as the first line of CVD intervention.1 At the core of this dietary guidance are the recommendations to decrease saturated fat and cholesterol and to consume more fruits, vegetables, and whole grain products. Information from an extensive database, especially regarding saturated fat, indicates that these diets significantly lower blood cholesterol levels, a major risk factor for CVD. Consequently, it is beyond debate that these diets reduce CVD risk. Since the advent of Step I and Step II diets, nutritionists have sought to develop effective implementation strategies, including identifying dietary patterns that augment the beneficial effects of these diets. Recent findings indicate that we are making impressive progress in attaining these goals. There is provocative evidence from the Lyon Diet Heart Study2 suggesting that a Mediterranean-style, Step I diet (emphasizing more bread, more root vegetables and green vegetables, more fish, less beef, lamb and pork replaced with poultry, no day without fruit, and butter and cream replaced with margarine high in α-linolenic acid) has effects that may be superior to those observed for the usual Step I diet. These findings raise the interesting, but not yet corroborated, question of whether a modified Step I diet (ie, a Mediterranean-style Step I diet) that features a dietary pattern consistent with the new American Heart Association (AHA) Dietary Guidelines may augment the Step I or Step II diets that are presently implemented in clinical practice. Defining a Mediterranean-style diet is challenging given the broad geographical region, including at least 16 countries, that borders the Mediterranean Sea. As would be expected, there are cultural, ethnic, religious, economic, and agricultural production differences that result in different dietary practices in these areas and that …