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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

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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

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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:We assessed the effectiveness of three interventions that were aimed to reduce non-acute low back pain (LBP) related symptoms in the occupational health setting. METHODS:Based on a survey (n =?2480; response rate 71%) on LBP, we selected a cohort of 193 employees who reported moderate LBP (Visual Analogue Scale VAS >?34 mm) and fulfilled at least one of the following criteria during the past 12 months: sciatica, recurrence of LBP???2 times, LBP???2 weeks, or previous sickness absence. A random sample was extracted from the cohort as a control group (Control, n =?50), representing the natural course of LBP. The remaining 143 employees were invited to participate in a randomised controlled trial (RCT) of three 1:1:1 allocated parallel intervention arms: multidisciplinary rehabilitation (Rehab, n =?43); progressive exercises (Physio, n?=?43) and self-care advice (Advice, n =?40). Seventeen employees declined participation in the intervention. The primary outcome measures were physical impairment (PHI), LBP intensity (Visual Analogue Scale), health related quality of life (QoL), and accumulated sickness absence days. We imputed missing values with multiple imputation procedure. We assessed all comparisons between the intervention groups and the Control group by analysing questionnaire outcomes at 2 years with ANOVA and sickness absence at 4 years by using negative binomial model with a logarithmic link function. RESULTS:Mean differences between the Rehab and Control groups were?-?3 [95% CI -5 to -?1] for PHI, -?13 [-?24 to -?1] for pain intensity, and 0.06 [0.00 to 0.12] for QoL. Mean differences between the Physio and Control groups were?-?3 [95% CI -5 to -?1] for PHI, -?13 [-?29 to 2] for pain intensity, and 0.07 [0.01 to 0.13] for QoL. The main effects sizes were from 0.4 to 0.6. The interventions were not effective in reducing sickness absence. CONCLUSIONS:Rehab and Physio interventions improved health related quality of life, decreased low back pain and physical impairment in non-acute, moderate LBP, but we found no differences between the Advice and Control group results. No effectiveness on sickness absence was observed. TRIAL REGISTRATION:Number NCT00908102 Clinicaltrials.gov.

Project description:BACKGROUND: The capacity to form romantic relationships and sexual health of adolescents in the Netherlands are compromised by several factors, including young age of first intercourse and adolescent depression. Several thresholds like own expenses, trust and embarrassment prevent adolescents to seek help for their sexual problems. To overcome these thresholds, brief sex counselling has been developed. It has been used since 2006 within the Rotterdam-Rijnmond Public Health Service, but there is lack of information about the (cost-) effectiveness. In the current study we will evaluate the (cost-) effectiveness of brief sex counselling for sexual problems in adolescents and young adults between 18 and 25 years of age. METHODS: In a randomised controlled trial we will compare (1) brief sex counselling with (2) intensive sexological treatment, and (3) delayed treatment (waiting list). Embedded in this RCT will be a trial-based economic evaluation, looking at the cost-effectiveness and cost-utility of brief sex counselling versus the two other interventions. Four hundred fifty adolescents (aged 18-25) with sexual problems will be recruited among the persons who visit the Public Health Service (PHS) and through various websites. After a screening procedure, eligible participants will be randomly allocated to one of the three intervention groups. Primary outcome measure of the clinical evaluation is the severity of sexual problems. Other outcomes include psychological distress, especially depression. The economic evaluation will be performed from a societal perspective. Costs will be assessed continuously by a retrospective questionnaire covering the last 3 month. All outcome assessments (including those for the economic evaluation) will take place via the internet at baseline, and at 3, 6, 9, and 12 months after baseline. DISCUSSION: The proposed research project will be the first study to provide preliminary data about the effect and cost-effectiveness of brief sex counselling in youth in comparison with intensive sexological treatment and delayed treatment. It is anticipated that positive results in (cost-) effectiveness of the proposed intervention will contribute to the improvement of sexual health care for adolescents and young adults. TRIAL REGISTRATION: The study has been registered at the Netherlands Trial Register, part of the Dutch Cochrane Centre (NTR1952).

Project description:ObjectiveTo investigate the effects of compliance and periodic telephone counselling by a pharmacist on mortality in patients receiving polypharmacy.DesignTwo year randomised controlled trial.SettingHospital medical clinic.Participants502 of 1011 patients receiving five or more drugs for chronic disease found to be non-compliant at the screening visit were invited for randomisation to either the telephone counselling group (n = 219) or control group (n = 223) at enrollment 12-16 weeks later.Main outcome measuresPrimary outcome was all cause mortality in randomised patients. Associations between compliance and mortality in the entire cohort of 1011 patients were also examined. Patients were defined as compliant with a drug if they took 80-120% of the prescribed daily dose. To calculate a compliance score for the whole treatment regimen, the number of drugs that the patient was fully compliant with was divided by the total number of prescribed drugs and expressed as a percentage. Only patients who complied with all recommended drugs were considered compliant (100% score).Results60 of the 502 eligible patients defaulted and only 442 patients were randomised. After two years, 31 (52%) of the defaulters had died, 38 (17%) of the control group had died, and 25 (11%) of the intervention group had died. After adjustment for confounders, telephone counselling was associated with a 41% reduction in the risk of death (relative risk 0.59, 95% confidence interval 0.35 to 0.97; P = 0.039). The number needed to treat to prevent one death at two years was 16. Other predictors included old age, living alone, rate of admission to hospital, compliance score, number of drugs for chronic disease, and non-treatment with lipid lowering drugs at screening visit. In the cohort of 1011 patients, the adjusted relative risk for death was 1.61 (1.05 to 2.48; P = 0.029) and 2.87 (1.80 to 2.57; P < 0.001) in patients with compliance scores of 34-66% and 0-33%, respectively, compared with those who had a compliance score of 67% or more.ConclusionIn patients receiving polypharmacy, poor compliance was associated with increased mortality. Periodic telephone counselling by a pharmacist improved compliance and reduced mortality.Trial registrationInternational Standard Randomised Controlled Trial Number Register: SRCTN48076318.

Project description:BackgroundInterventions to increase physical activity (PA) among older community-dwelling adults may be enhanced by using multidimensional health risk assessment (HRA) as a basis for PA counselling.MethodsThe study was conducted among nondisabled but mostly frail persons 65 years of age and older at an ambulatory geriatric clinic in Bucharest, Romania. From May to July 2014, 200 participants were randomly allocated to intervention and control groups. Intervention group participants completed an initial HRA questionnaire and then had monthly counselling sessions with a geriatrician over a period of six months that were aimed at increasing low or maintaining higher PA. Counselling also addressed the older persons' concomitant health risks and problems. The primary outcome was PA at six months (November 2014 to February 2015) evaluated with the International Physical Activity Questionnaire.ResultsAt baseline, PA levels were similar in intervention and control groups (median 1089.0, and 1053.0 MET [metabolic equivalent of task] minutes per week, interquartile ranges 606.0-1401.7, and 544.5-1512.7 MET minutes per week, respectively). Persons in the intervention group had an average of 11.2 concomitant health problems and risks (e.g., pain, depressive mood, hypertension). At six months, PA increased in the intervention group by a median of 180.0 MET minutes per week (95% confidence interval (CI) 43.4-316.6, p = 0.01) to 1248.8 MET minutes per week. In the control group, PA decreased by a median of 346.5 MET minutes per week (95% CI 178.4-514.6, p<0.001) to 693.0 MET minutes per week due to a seasonal effect, resulting in a difference of 420.0 MET minutes per week (95% CI 212.7-627.3, p< 0.001) between groups.ConclusionThe use of HRA to inform individualized PA counselling is a promising method for achieving improvements in PA, and ultimately health and longevity among large groups of community-dwelling older persons.Trial registrationInternational Standard Randomized Controlled Trial Number: ISRCTN11166046.

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

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

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