Dataset Information

Move-It: A Cluster-Randomised Digital Worksite Exercise Intervention in China: Outcome and Process Evaluation.

ABSTRACT: We evaluate the outcomes and processes of a video and web-based worksite exercise intervention for sedentary office workers in China, in a 2-arm cluster-randomised wait-list control trial (n = 282: intervention (INT) n = 196 and wait-list control (WLC) n = 86). Eligible clusters were two sites of a major organisation in China randomly allocated to each group (INT: Guangzhou; WLC: Beijing); eligible participants were site employees (n = 690). A theoretically informed digital workplace intervention (Move-It) involving a 10 min Qigong exercise session (video demonstration via website) was delivered twice a day at set break times during the working day for 12 consecutive weeks. Individual-level outcomes were assessed. Participants' physical activity increased significantly from baseline to post-intervention similarly in both the intervention and the control group. There was a significantly smaller increase in weekday sitting hours in intervention than controls (by 4.66 h/week), and work performance increased only in the control group. Process evaluation (including six focus groups) was conducted using the RE-AIM (reach, effectiveness, adoption, implementation and maintenance) framework. The intervention had wide reach and was successfully marketed to all employees with good uptake. The participatory approach increased perceived organisational support and enhanced adoption. The intervention was implemented broadly as planned. Qigong worksite exercise intervention can be successfully delivered to sedentary office workers in China using video and web-based platforms. It may increase physical activity and does not adversely affect perceived work performance. The study highlights the complexity of conducting health promotion research in real-world organisational settings.

SUBMITTER: Blake H

PROVIDER: S-EPMC6766073 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Move-It: A Cluster-Randomised Digital Worksite Exercise Intervention in China: Outcome and Process Evaluation.

Blake Holly H Lai Betsy B Coman Emil E Houdmont Jonathan J Griffiths Amanda A

International journal of environmental research and public health 20190917 18

We evaluate the outcomes and processes of a video and web-based worksite exercise intervention for sedentary office workers in China, in a 2-arm cluster-randomised wait-list control trial (n = 282: intervention (INT) n = 196 and wait-list control (WLC) n = 86). Eligible clusters were two sites of a major organisation in China randomly allocated to each group (INT: Guangzhou; WLC: Beijing); eligible participants were site employees (n = 690). A theoretically informed d ...[more]

PMID: 31533292

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Project description:BackgroundThe process evaluation of the Vital@Work intervention was primary aimed at gaining insight into the context, dose delivered, fidelity, reach, dose received, and participants' attitude. Further, the differences between intervention locations were evaluated.MethodsEligible for this study were 730 workers, aged ≥ 45 years, from two academic hospitals. Workers randomised to the intervention group (n = 367) received a 6-months intervention consisting a Vitality Exercise Programme (VEP) combined with three visits to a Personal Vitality Coach (PVC), aimed at goal setting, feedback, and problem solving. The VEP consisted of a guided yoga session, a guided workout session, and aerobic exercising without direct face-to-face instruction, all once a week. Data were collected by means of a questionnaire after the intervention, attendance registration forms (i.e. attendance at guided VEP group sessions), and coaching registration forms (filled in by the PVCs).ResultsThe dose delivered of the yoga and workout sessions were 72.3% and 96.3%. All PVC visits (100%) were offered. The reach for the yoga sessions, workout sessions and PVC visits was 70.6%, 63.8%, and 89.6%, respectively. When taken these three intervention components together, the reach was 52%. This differed between the two locations (59.2% versus 36.8%). The dose received was for the yoga 10.4 sessions/24 weeks and for the workout 11.1 sessions/24 weeks. The attendance rate, defined as the mean percentage of attended group sessions in relation to the total provided group sessions, for the yoga and workout sessions was 51.7% and 44.8%, respectively. For the yoga sessions this rate was different between the two locations (63.2% versus 46.5%). No differences were found between the locations regarding the workout sessions and PVC visits. Workers attended on average 2.7 PVC visits. Overall, workers were satisfied with the intervention components: 7.5 for yoga sessions, 7.8 for workout sessions, and 6.9 for PVC visits.ConclusionsThe implementation of the intervention was accomplished as planned with respect to the dose delivered. Based on the reach, most workers were willing to attend the guided group sessions and the PVC visits, although there were differences between the locations and between intervention components. Overall, workers were positive about the intervention.Trial registrationTrial registration NTR1240.

Project description:IntroductionThere is increasing evidence demonstrating the benefits of exercise in counteracting cancer treatment-related fatigue. Immunotherapy is an established treatment for advanced melanoma, and is associated with fatigue in a third of patients. The safety and efficacy of exercise in counteracting treatment-related fatigue in patients with advanced melanoma receiving immunotherapy are yet to be determined. This study aims to assess the safety, adherence to and acceptability of a mixed-methods parallel-group, pilot randomised controlled trial of a personalised, 12-week semi-supervised exercise programme prescribed by an exercise physiologist (iMove) in 30 patients with stage IV melanoma scheduled to commence immunotherapy: single agent ipilimumab, nivolumab or pembrolizumab, or combination ipilimumab and nivolumab. The trial will be used to provide preliminary evidence of the potential efficacy of exercise for managing fatigue.Methods and analysisThirty participants will be recruited from a specialist cancer centre between May and September, 2019. Participants will be randomised 1:1 to receive iMove, or usual care (an information booklet about exercise for people with cancer). Feasibility data comprise: eligibility; recruitment and retention rates; adherence to and acceptability of exercise consultations, personalised exercise programme and study measures; and exercise-related adverse events. Patient-reported outcome measures assess potential impact of the exercise intervention on: fatigue, role functioning, symptoms and quality of life. Follow-up will comprise five time points over 24 weeks. Physical assessments measure physical fitness and functioning.Ethics and disseminationThis study was reviewed and approved by the Peter MacCallum Cancer Centre Human Research Ethics Committee (HREC/48927/PMCC-2019). The findings from this trial will be disseminated via conference presentations and publications in peer-reviewed journals, and by engagement with clinicians, media, government and consumers. In particular, we will promote the outcomes of this work among the oncology community should this pilot indicate benefit for patients.Trial registration numberACTRN12619000952145; Pre-results.

Project description:Summary Background Drug-sensitive tuberculosis treatment requires 6 months of therapy, so adherence problems are common. Digital adherence technologies might improve tuberculosis treatment outcomes. We aimed to evaluate the effect of a daily reminder medication monitor, monthly review of adherence data by the health-care provider, and differentiated care for patients with adherence issues, on tuberculosis treatment adherence and outcomes. Methods We did a cluster-randomised superiority trial across four prefectures in China. 24 counties or districts (clusters) were randomly assigned (1:1) to intervention or control groups. We enrolled patients aged 18 years or older with GeneXpert-positive, rifampicin-sensitive pulmonary tuberculosis, who were receiving daily fixed-dose combination treatment. Patients in the intervention group received a medication monitor for daily drug-dosing reminders, monthly review of adherence data by health-care provider, and management of poor adherence; and patients in the control group received routine care (silent-mode monitor-measured adherence). Only the independent endpoints review committee who assessed endpoint data for some participants were masked to study group assignment. Patients were followed up (with sputum solid culture) at 12 and 18 months. The primary outcome was a composite of death, loss to follow-up, treatment failure, switch to multidrug-resistant tuberculosis treatment, or tuberculosis recurrence by 18 months from treatment start, analysed in the intention-to-treat population. Analysis accounted for study design with multiple imputation for the primary outcome. This trial is now complete and is registered with ISRCTN, 35812455. Findings Between Jan 26, 2017, and April 3, 2019, 15 257 patients were assessed for eligibility and 3074 were enrolled, 2686 (87%) of whom were included in the intention-to-treat population. 1909 (71%) of 2686 patients were male, 777 (29%) were female, and the median age was 44 years (IQR 29–58). By 18 months from treatment start, using multiple imputation for missing outcomes, 239 (16% [geometric mean of cluster-level proportion]) of 1388 patients in the control group and 224 (16%) of 1298 in the intervention group had a primary composite outcome event (289 [62%] of 463 events were loss to follow-up during treatment and 42 [9%] were tuberculosis recurrence). The intervention had no effect on risk of the primary composite outcome (adjusted risk ratio 1·01, 95% CI 0·73–1·40). Interpretation Our digital medication monitor intervention had no effect on unfavourable outcomes, which included loss to follow-up during treatment, tuberculosis recurrence, death, and treatment failure. There was a failure to change patient management following identification of treatment non-adherence at monthly reviews. A better understanding of adherence patterns and how they relate to poor outcomes, coupled with a more timely review of adherence data and improved implementation of differentiated care, may be required. Funding Bill & Melinda Gates Foundation.

Project description:BackgroundThere is limited evidence, mainly from high-income countries, that digital health interventions improve type 2 diabetes (T2DM) care. Large-scale implementation studies are lacking.MethodsA multifaceted digital health intervention comprising: (1) a self-management application ('app') for patients and lay 'family health promotors' (FHPs); and (2) clinical decision support for primary care doctors was evaluated in an open-label, parallel, cluster randomized controlled trial in 80 communities (serviced by a primary care facility for >1000 residents) in Hebei Province, China. People >40 years with T2DM and a glycated haemoglobin (HbA1c) ≥7% were recruited (∼25/community). After baseline assessment, community clusters were randomly assigned to intervention or control groups (1:1) via a web-based system, stratified by locality (rural/urban). Control arm clusters received usual care without access to the digital health application or family health promoters. The primary outcome was at the participant level defined as the proportion with ≥2 "ABC" risk factor targets achieved (HbA1c < 7.0%, blood pressure < 140/80 mmHg and LDL-cholesterol < 2.6 mmol/L) at 24 months.FindingsA total of 2072 people were recruited from the 80 community clusters (40 urban and 40 rural), with 1872 (90.3%) assessed at 24 months. In the intervention arm, patients used FHPs for support more in rural than urban communities (252 (48.6%) rural vs 92 (21.5%) urban, p < 0.0001). The mean monthly proportion of active app users was 46.4% (SD 7.8%) with no significant difference between urban and rural usage rates. The intervention was associated with improved ABC control rates (339 [35.9%] intervention vs 276 [29.9%] usual care; RR 1.20, 95% CI 1.02-1.40; p = 0.025), with significant heterogeneity by geography (rural 220 [42.6%] vs 158 [31.0%]; urban 119 [27.9%] vs 118 [28.6%]; p = 0.022 for interaction). Risk factor reductions were mainly driven by improved glycaemic control (mean HbA1C difference -0.33%, 95% CI -0.48 to -0.17; p = 0.00025 and mean fasting plasma glucose difference -0.58 mmol, 95% CI -0.89 to -0.27; p = 0.00013). There were no changes in blood pressure and LDL-cholesterol levels.InterpretationA multifaceted digital health intervention improved T2DM risk factor control rates, particularly in rural communities where there may be stronger relationships between patients and doctors and greater family member support.FundingNational Health and Medical Research CouncilGlobal Alliance for Chronic Diseases (ID 1094712).

Project description:ObjectivesTo study the implementation of a cluster randomised controlled effectiveness-implementation hybrid trial testing the effectiveness of a medication review at hospital discharge combined with a communication stimulus between hospital physicians (HPs) and general practitioners (GPs) on rehospitalisation of multimorbid older patients.DesignExtension of Grant's mixed method process evaluation framework to trials with multilevel clustering.SettingGeneral internal medicine wards in Swiss hospitals.ParticipantsConvenience samples of 15 chief physicians (of 21 hospitals participating in the effectiveness trial), 60 (74) senior HPs, 65 (164) junior HPs and 187 (411) GPs.Implementation strategyTwo-hour teaching sessions for senior HPs on a patient-centred, checklist-guided discharge routine.Process evaluation componentsData collection on recruitment, delivery and response from chief physicians (semistructured interviews), senior HPs, junior HPs, GPs (surveys) and patients (via HPs). Quantitative data were summarised using descriptive statistics, and interviews analysed using thematic analysis.Outcome measuresIntervention dose (quantitative), implementation fidelity (qualitative), feasibility and acceptability, facilitators and barriers, implementation support strategies.ResultsRecruitment of hospitals was laborious but successful, with 21 hospitals recruited. Minimal workload and a perceived benefit for the clinic were crucial factors for participation. Intervention dose was high (95% of checklist activities carried out), but intervention fidelity was limited (discharge letters) or unknown (medication review). Recruitment and retention of patients was challenging, partly due to patient characteristics (old, frail) and the COVID-19 pandemic: Only 612 of the anticipated 2100 patients were recruited, and 31% were lost to follow-up within the first month after discharge. The intervention was deemed feasible and helpful by HPs, and the relevance of the topic appreciated by both HPs and GPs.ConclusionsThe results from this evaluation will support interpretation of the findings of the effectiveness study and may inform researchers and policy makers who aim at improving hospital discharge.Trial registration numberISRCTN18427377.

Project description:BackgroundThe Bridging the Age Gap in Breast Cancer research programme sought to improve treatment decision-making for older women with breast cancer by developing and testing, in a cluster randomised trial (n = 1339 patients), two decision support interventions (DESIs). Both DESIs were used in the intervention arm and each comprised an online risk prediction model, brief decision aid and information booklet. One DESI supported the decision to have either primary endocrine therapy (PET) or surgery with adjuvant therapies and the second supported the decision to have adjuvant chemotherapy after surgery or not.MethodsSixteen sites were randomly selected to take part in the process evaluation. Multiple methods of data collection were used. Medical Research Council (MRC) guidelines for the evaluation of complex interventions were used.ResultsEighty-two patients, mean age 75.5 (range 70-93), provided data for the process evaluation. Seventy-three interviews were completed with patients. Ten clinicians from six intervention sites took part in telephone interviews. Dose: Ninety-one members of staff in the intervention arm received intervention training. Reach: The online tool was accessed on 324 occasions by 27 clinicians. Reasons for non-use of the online tool were commonly that the patient had already made a decision or that there was no online access in the clinic. Of the 32 women for whom there were data available, fifteen from the intervention arm and six from the usual care arm were offered a choice of treatment. Fidelity: Clinicians used the online tool in different ways, with some using it during the consultation and others checking the online survival estimates before the consultation. Adaptation: There was evidence of adaptation when using the DESIs. A lack of infrastructure, e.g. internet access, was a barrier to the use of the online tool. The brief decision aid was rarely used. Mediators: Shared decision-making: Most patients felt able to contribute to decision-making and expressed high levels of satisfaction with the process. Participants' responses to intervention: Six patients reported the DESIs to be very useful, one somewhat useful and two moderately useful.ConclusionsClinicians who participated were mainly supportive of the interventions and had attempted some adaptations to make the interventions applicable, but there were practical and engagement barriers that led to sub-optimal adoption in routine practice.Trial registrationISRCTN46099296 . Registered on 11 August 2016-retrospectively registered.

Dataset Information

Move-It: A Cluster-Randomised Digital Worksite Exercise Intervention in China: Outcome and Process Evaluation.

Publications

Move-It: A Cluster-Randomised Digital Worksite Exercise Intervention in China: Outcome and Process Evaluation.

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