Dataset Information

The effectiveness of physical activity monitoring and distance counselling in an occupational health setting--a research protocol for a randomised controlled trial (CoAct).

ABSTRACT: The CoAct (Cocreating Activity) study is investigating a novel lifestyle intervention, aimed at the working population, with daily activity monitoring and distance counselling via telephone and secure web messages. The main purpose of this study is to evaluate the effectiveness of lifestyle counselling on the level of physical activity in an occupational health setting. The purposes include also analysing the potential effects of changes in physical activity on productivity at work and sickness absence, and healthcare costs. This article describes the design of the study and the participant flow until and including randomization.CoAct is a randomised controlled trial with two arms: a control group and intervention group with daily activity monitoring and distance counselling. The intervention focuses on lifestyle modification and takes 12 months. The study population consists of volunteers from 1100 eligible employees of a Finnish insurance company. The primary outcomes of this study are change in physical activity measured in MET minutes per week, work productivity and sickness absence, and healthcare utilisation. Secondary outcomes include various physiological measures. Cost-effectiveness analysis will also be performed. The outcomes will be measured by questionnaires at baseline, after 6, 12, and 24 months, and sickness absence will be obtained from the employer's registers.No trials are yet available that have evaluated the effectiveness of daily physical activity monitoring and distance counselling in an occupational health setting over a 12 month period and no data on cost-effectiveness of such intervention are available.ClinicalTrials.gov identifier: NCT00994565.

SUBMITTER: Reijonsaari K

PROVIDER: S-EPMC2811115 | biostudies-literature | 2009 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The effectiveness of physical activity monitoring and distance counselling in an occupational health setting--a research protocol for a randomised controlled trial (CoAct).

Reijonsaari Karita K Vehtari Aki A van Mechelen Willem W Aro Timo T Taimela Simo S

BMC public health 20091231

<h4>Background</h4>The CoAct (Cocreating Activity) study is investigating a novel lifestyle intervention, aimed at the working population, with daily activity monitoring and distance counselling via telephone and secure web messages. The main purpose of this study is to evaluate the effectiveness of lifestyle counselling on the level of physical activity in an occupational health setting. The purposes include also analysing the potential effects of changes in physical activity on productivity at ...[more]

PMID: 20043831

Similar Datasets

Project description:BackgroundLack of physical activity (PA) is a known risk factor for many health conditions. The workplace is a setting often used to promote activity and health. We investigated the effectiveness of an intervention on PA and productivity-related outcomes in an occupational setting.MethodsWe conducted a randomized controlled trial of 12 months duration with two 1:1 allocated parallel groups of insurance company employees. Eligibility criteria included permanent employment and absence of any condition that risked the participant's health during PA. Subjects in the intervention group monitored their daily PA with an accelerometer, set goals, had access to an online service to help them track their activity levels, and received counseling via telephone or web messages for 12 months. The control group received the results of a fitness test and an information leaflet on PA at the beginning of the study. The intervention's aim was to increase PA, improve work productivity, and decrease sickness absence. Primary outcomes were PA (measured as MET minutes per week), work productivity (quantity and quality of work; QQ index), and sickness absence (SA) days at 12 months. Participants were assigned to groups using block randomization with a computer-generated scheme. The study was not blinded.ResultsThere were 544 randomized participants, of which 521 were included in the analysis (64% female, mean age 43 years). At 12 months, there was no significant difference in physical activity levels between the intervention group (n = 264) and the control group (n = 257). The adjusted mean difference was -206 MET min/week [95% Bayesian credible interval -540 to 128; negative values favor control group]. There was also no significant difference in the QQ index (-0.5 [-4.4 to 3.3]) or SA days (0.0 [-1.2 to 0.9]). Of secondary outcomes, body weight (0.5 kg [0.0 to 1.0]) and percentage of body fat (0.6% [0.2% to 1.1%]) were slightly higher in the intervention group. An exploratory subgroup analysis revealed no subgroups in which the intervention affected physical activity. No adverse events were reported.ConclusionsThe intervention was not found effective, and this study does not provide support for the effectiveness of the workplace PA intervention used here.Trial registrationClinicalTrials.gov identifier: NCT00994565.

Project description:BackgroundPhysical inactivity is a leading risk factor for chronic disease. Brief physical activity counselling delivered within healthcare systems has been shown to increase physical activity levels; however, implementation efforts have mostly targeted primary healthcare and uptake has been sub-optimal. The Brief Physical Activity Counselling by Physiotherapists (BEHAVIOUR) trial aims to address this evidence-practice gap by evaluating (i) the effectiveness of a multi-faceted implementation strategy, relative to usual practice for improving the proportion of patients receiving brief physical activity counselling as part of their routine hospital-based physiotherapy care and (ii) effectiveness of brief physical activity counselling embedded in routine physiotherapy care, relative to routine physiotherapy care, at improving physical activity levels among patients receiving physiotherapy care.MethodsEffectiveness-implementation hybrid type II cluster randomised controlled trial with embedded economic evaluation, qualitative study and culturally adapted patient-level outcome measures. The trial will be conducted across five hospitals in a local health district in Sydney, Australia, with a lower socioeconomic and culturally diverse population. The evidence-based intervention is brief physical activity counselling informed by the 5As counselling model and behavioural theory, embedded into routine physiotherapy care. The multi-faceted strategy to support the implementation of the counselling intervention was developed with key stakeholders guided by the Consolidated Framework for Implementation Research and the Capabilities, Opportunities, Motivation-Behaviour (COM-B) theoretical model, and consists of clinician education and training, creating a learning collaborative, tailored strategies to address community referral barriers, team facilitation, and audit and feedback. Thirty teams of physiotherapists will be randomised to receive the multi-faceted implementation strategy immediately or after a 9-month delay. Each physiotherapy team will recruit an average of 10 patients (n=300) to collect effectiveness outcomes at baseline and 6 months. The primary effectiveness outcome is self-reported planned physical activity using the Incidental and Planned Exercise Questionnaire, and the primary implementation outcome is reach (proportion of eligible new physiotherapy patients who receive brief physical activity counselling). Secondary effectiveness and implementation outcomes will also be collected.DiscussionThis project focuses on physiotherapists as health professionals with the requisite skills and patterns of practice to tackle the increasing burden of chronic disease in a high-risk population.Trial registrationANZCTR, ACTRN12621000194864 . Registered on 23 February 2021.

Project description:INTRODUCTION:In recent years, medical treatment for cancer has improved, thereby increasing the life expectancy of patients with cancer. Hence, the focus in healthcare shifted towards analysing treatments that offer to decrease distress and improve the quality of life of patients with cancer. The psychological burden of patients with cancer originates from all kinds of psychosocial challenges related to diagnosis and treatment. Cancer counselling centres (CCounCs) try to address these concerns. However, the current literature lacks research on the effectiveness of CCounCs. This study aims to assess the effectiveness of CCounCs with regard to distress and other relevant psychosocial variables (quality of life, anxietyand so on). METHODS AND ANALYSIS:This prospective observational study with a non-randomised control group has three measurement points: before the first counselling session (baseline, t0) and at 2?weeks and 3?months after baseline (t1, t2). Patients and their relatives who seek counselling between December 2018 and November 2020 and have sufficient German language skills will be included. The control group will be recruited at clinics and oncological outpatient centres in Hamburg. Propensity scoring will be applied to adjust for differences between the control and intervention groups at baseline. Sociodemographic data, medical data and counselling concerns are measured at baseline. Distress (distress thermometer), quality of life (Short Form-8 Health Survey, European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30), anxiety (Generalized AnxietyDisorder-7), depression (Patient HealthQuestionnaire-9) and further psychosocial variables are assessed at all time points. With a total of 787 participants, differences between the intervention and control groups of a small effect size (f=0.10) can be detected with a power of 80%. ETHICS AND DISSEMINATION:The study was registered prior to data collection with the German Registration of Clinical Trials in September 2018. Ethical approval was received by the local psychological ethical committee of the Center for Psychosocial Medicine at the University Medical Centre Hamburg-Eppendorf in August 2018. The results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER:DRKS00015516; Pre-results.

Project description:BACKGROUND:One in ten children in Britain have been identified as experiencing a diagnosable mental health disorder. School-based humanistic counselling (SBHC) may help young people identify, address, and overcome psychological distress. Data from four pilot trials suggest that SBHC may be clinically effective. However, a fully powered randomised controlled trial (RCT) is needed to provide a robust test of its effectiveness, to assess its cost-effectiveness, and to determine the process of change. METHODS/DESIGN:The Effectiveness and Cost-effectiveness Trial of Humanistic Counselling in Schools (ETHOS) is a two-arm, parallel-group RCT comparing the clinical and cost-effectiveness of SBHC with Pastoral Care as Usual (PCAU) in school settings. Eligibility criteria for young people include being between 13 and 16 years of age and experiencing moderate to severe levels of emotional distress. Participants are randomised to receive either SBHC or PCAU. SBHC is delivered in up to 10 weekly, individual sessions in their school with a qualified, experienced counsellor who has also received training using a clinical practice manual. Adherence to the SBHC model is assessed by a sub-team of auditors and in clinical supervision. PCAU consists of the schools' pre-existing systems for supporting the emotional health and well-being of students. The primary outcomes are psychological distress measured using the Young Person's Clinical Outcomes in Routine Evaluation (YP-CORE) and costs evaluated using the Client Service Receipt Inventory (CSRI). Secondary outcomes include psychological difficulties, levels of depression, anxiety and self-esteem, well-being, school engagement, educational outcomes and achievement of personal goals. Qualitative interviews with participants, parents and school staff will look to identify the mechanisms of change in SBHC. Researchers administering the measures are blind to allocation. The trial requires n = 306 participants (n = 153 in each group), with 90% power to detect a standardised mean difference (SMD) of 0.5. An intention-to-treat analysis will be undertaken. DISCUSSION:This RCT is powered to detect clinically meaningful differences, and will make a major contribution to the evidence base for mental health provision for adolescents. It will have implications for all stakeholders, including policy-makers, statutory advisory bodies for child welfare, head teachers, children and young people practitioners, child welfare and parenting organisations, and young people. TRIAL REGISTRATION:Controlled Trials International Standard Randomised Controlled Trial Number (ISRCTN) Registry, ID: ISRCTN10460622 . Registered on 11 May 2016.

Project description:INTRODUCTION:The most promising way to promote active life years in old age is to promote regular participation in physical activity (PA). Maintaining lower extremity muscle function with good balance has been associated with fewer falls and the need of help from others. This article describes the design and intervention of a randomised controlled trial (RCT) investigating the effectiveness of a health and PA counselling programme on life-space mobility and falls rates in community-dwelling older adults at the Health Kiosk and/or Service Centre. METHODS AND ANALYSIS:Community-dwelling men and women (n=450) aged 65 years and over with early phase mobility limitation will be recruited to a 24-month RCT with a 24-month follow-up. Participants will be randomly allocated into either a health and PA counselling group (intervention) or relaxation group (control intervention). All participants will receive five group specific face-to-face counselling sessions and 11 phone calls. The counselling intervention will include individualised health counselling, strength and balance training, and guidance to regular PA. The control group will receive relaxation exercises. Outcomes will be assessed at baseline, 12, 24 and 48 months. Primary outcomes are average life-space mobility score and falls rates. Life-space mobility will be assessed by a validated questionnaire. Falls rates will be recorded from fall diaries. Secondary outcomes are data on fall-induced injuries and living arrangements, number of fallers, fracture risk, mean level of PA, physical performance, quality of life, mood, cognition, balance confidence and fear of falling. Data will be analysed using the intention-to-treat principle. Cost-effectiveness of the programme will be analysed. Ancillary analyses are planned in participants with greater adherence. ETHICS AND DISSEMINATION:Ethical approval was obtained from the Ethics Committee of the Tampere University Hospital (R15160). Outcomes will be disseminated through publication in peer-reviewed journals and presentations at international conferences. TRIAL REGISTRATION:ISRCTN65406039; Pre-results.

Project description:Physical activity is important for a healthy lifestyle. Although physical activity can delay complications and decrease the burden of the disease, the level of activity of patients with chronic obstructive pulmonary disease (COPD) or type 2 Diabetes Mellitus (DM2) is often far from optimal. To stimulate physical activity, a monitoring and feedback tool, consisting of an accelerometer linked to a smart phone and webserver (It's LiFe! tool), and a counselling protocol for practice nurses in primary care was developed (the Self-management Support Program). The main objective of this study is to measure the longitudinal effects of this counselling protocol and the added value of using the tool.This three-armed cluster randomised controlled trial with 120 participants with COPD and 120 participants with DM2 (aged 40-70), compares the counselling protocol with and without the use of the tool (group 1 and 2) with usual care (group 3). Recruitment takes place at GP practices in the southern regions of the Netherlands. Randomisation takes place at the practice level. The intended sample (three arms of 8 practices) powers the study to detect a 10-minute difference of moderate and intense physical activity per day between groups 1 and 3. Participants in the intervention groups have to visit the practice nurse 3-4 times for physical activity counselling, in a 4-6-month period. Specific activity goals tailored to the individual patient's preferences and needs will be set. In addition, participants in group 1 will be instructed to use the tool in daily life. The primary outcome, physical activity, will be measured in all groups with a physical activity monitor (PAM). Secondary outcomes are quality of life, general - and exercise - self-efficacy, and health status. Follow-up will take place after 6 and 9 months. Separately, a process evaluation will be conducted to explore reasons for trial non-participation, and the intervention's acceptability for participating patients and nurses.Results of this study will give insight into the effects of the It's LiFe! monitoring and feedback tool combined with care from a practice nurse for people with COPD or DM2 on physical activity.ClinicalTrials.gov: NCT01867970.

Project description:BackgroundGenetic counselling aims to identify, and address, patient needs while facilitating informed decision-making about genetic testing and promoting empowerment and adaptation to genetic information. Increasing demand for cancer genetic testing and genetic counsellor workforce capacity limitations may impact the quality of genetic counselling provided. The use of a validated genetic-specific screening tool, the Genetic Psychosocial Risk Instrument (GPRI), may facilitate patient-centred genetic counselling. The aim of this study is to assess the effectiveness and implementation of using the GPRI in improving patient outcomes after genetic counselling and testing for an inherited cancer predisposition.MethodsThe PersOnalising gEneTIc Counselling (POETIC) trial is a hybrid type 2 effectiveness-implementation trial using a randomised control trial to assess the effectiveness of the GPRI in improving patient empowerment (primary outcome), while also assessing implementation from the perspective of clinicians and the healthcare service. Patients referred for a cancer risk assessment to the conjoint clinical genetics service of two metropolitan hospitals in Victoria, Australia, who meet the eligibility criteria and consent to POETIC will be randomised to the usual care or intervention group. Those in the intervention group will complete the GPRI prior to their appointment with the screening results available for the clinicians' use during the appointment. Appointment audio recordings, clinician-reported information about the appointment, patient-reported outcome measures, and clinical data will be used to examine the effectiveness of using the GPRI. Appointment audio recordings, health economic information, and structured interviews will be used to examine the implementation of the GPRI.DiscussionThe POETIC trial takes a pragmatic approach by deploying the GPRI as an intervention in the routine clinical practice of a cancer-specific clinical genetics service that is staffed by a multidisciplinary team of genetics and oncology clinicians. Therefore, the effectiveness and implementation evidence generated from this real-world health service setting aims to optimise the relevance of the outcomes of this trial to the practice of genetic counselling while enhancing the operationalisation of the screening tool in routine practice.Trial registrationAustralian New Zealand Clinical Trials Registry registration number 12621001582842p. Date of registration: 19th November 2021.

Project description:BackgroundAs life expectancy increases and the number of older people, particularly those aged 85 years and over, expands there is an increase in demand for long-term care. A large proportion of people in a care home setting spend most of their time sedentary, and this is one of the leading preventable causes of death. Encouraging residents to engage in more physical activity could deliver benefits in terms of physical and psychological health, and quality of life. This study is the final stage of a programme of research to develop and preliminarily test an evidence-based intervention designed to enhance opportunities for movement amongst care home residents, thereby increasing levels of physical activity.Methods/designThis is a cluster randomised feasibility trial, aiming to recruit at least 8-12 residents at each of 12 residential care homes across Yorkshire, UK. Care homes will be randomly allocated on a 1:1 basis to receive either the intervention alongside usual care, or to continue to provide usual care alone. Assessment will be undertaken with participating residents at baseline (prior to care home randomisation) and at 3, 6, and 9 months post-randomisation. Data relating to changes in physical activity, physical function, level of cognitive impairment, mood, perceived health and wellbeing, and quality of life will be collected. Data at the level of the home will also be collected and will include staff experience of care, and changes in the numbers and types of adverse events residents experience (for example, hospital admissions, falls). Details of National Health Service (NHS) usage will be collected to inform the economic analysis. An embedded process evaluation will obtain information to test out the theory of change underpinning the intervention and its acceptability to staff and residents.DiscussionThis feasibility trial with embedded process evaluation and collection of health economic data will allow us to undertake detailed feasibility work to inform a future large-scale trial. It will provide valuable information to inform research procedures in this important but challenging area.Trial registrationISRCTN registry, ISRCTN16076575 . Registered on 25 June 2015.

Dataset Information

The effectiveness of physical activity monitoring and distance counselling in an occupational health setting--a research protocol for a randomised controlled trial (CoAct).

Publications

The effectiveness of physical activity monitoring and distance counselling in an occupational health setting--a research protocol for a randomised controlled trial (CoAct).

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets