Study protocol of a co-created primary organizational-level intervention with the aim to improve organizational and social working conditions and decrease stress within the construction industry – a controlled trial

Abstract Background Within construction industry, physical work exposures have long been recognized as possible determinants for musculoskeletal disorders, but less attention has been given the increasing organizational and social work hazards and stress within this industry. There is to date a lack of knowledge about how to improve organizational and social working conditions and decrease stress within the construction industry. Methods This paper outlines the design of a controlled trial to evaluate the effectiveness of a co-created organizational-level intervention with the aim to improve role clarity, quantitative demands, staffing, planning, team effectiveness, psychosocial safety climate and stress. Two regions (> 700 employees) within one large construction company in Sweden will participate as intervention and control group. Further we present the design of the process evaluation assessing fidelity, support from managers, readiness for change and contextual factors. We will utilize questionnaires, semi-structured interviews, observations and documentation as means for data collection, hence a mixed methods approach is applied. Discussion The study is expected to contribute to the understanding of how adverse organizational and social working conditions and stress can be improved within the construction industry. By applying co-creation we wish to develop an intervention and implementation strategies that fit to the context, are in line with the needs of end-users and are supported by all management levels - all of which are highlighted features in successful workplace interventions. Trial registration ISRCTN, ISRCTN16548039. Registered 12/02/20. Retrospectively registered

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Community-based culinary and nutrition education intervention promotes fruit and vegetable consumption

Public Health Nutrition ◽

10.1017/s1368980021003797 ◽

2021 ◽

pp. 1-13

Author(s):

Jessica Jarick Metcalfe ◽

Melissa Pflugh Prescott ◽

Melissa Schumacher ◽

Caitlin Kownacki ◽

Jennifer McCaffrey

Keyword(s):

Nutrition Education ◽

Vegetable Consumption ◽

Controlled Trial ◽

Fruit And Vegetable Consumption ◽

Control Group ◽

Fruit And Vegetable ◽

Structured Interviews ◽

Post Intervention ◽

Cooking Classes ◽

The Impact

Abstract Objective: The main objective of this study was to evaluate the impact of the Market to MyPlate (M2MP) program on fruit and vegetable consumption and cooking behaviours. Secondary objectives were to examine factors that affected participant retention and program completion, and analyse program feedback provided by participants. Design: This study conducted a mixed methods evaluation embedded within a cluster randomised controlled trial of the M2MP intervention. Adult participants completed a pre- and post-program survey reporting on their fruit and vegetable consumption and cooking behaviours. A subsample participated in structured interviews, providing feedback about M2MP and the impact of the program. Setting: Seven weekly classes took place in community centres and extension offices in central Illinois. Participants: 120 adults and their families participated. Class cohorts were randomly assigned to one of three treatment groups: (1) nutrition education and cooking classes with produce allocations (PAE, n 39); (2) nutrition education and cooking classes only (EO, n 36) or (3) control group (n 45). Results: Compared to control, PAE participants reported larger increases from pre- to post-intervention in fruit (P = 0·001) and vegetable consumption (P = 0·002), with no differences in cooking frequency. Interview analyses identified key themes in behaviour changes due to M2MP, including reported increases in dietary variety, cooking self-efficacy and children’s participation in cooking. Conclusions: PAE participants who received an intervention that directly increased their access to fresh produce (via produce allocations) increased their reported fruit and vegetable consumption. Though participants’ cooking frequency did not change, interviewees reported increased variety, cooking confidence and family participation in cooking.

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Breast cancer application protocol: a randomised controlled trial to evaluate a self-management app for breast cancer survivors

BMJ Open ◽

10.1136/bmjopen-2019-034655 ◽

2020 ◽

Vol 10 (7) ◽

pp. e034655

Author(s):

Andy S K Cheng ◽

Xiangyu Liu ◽

Peter H F Ng ◽

Cindy T T Kwok ◽

Yingchun Zeng ◽

...

Keyword(s):

Breast Cancer ◽

Breast Cancer Survivors ◽

Controlled Trial ◽

Intervention Group ◽

Readiness For Change ◽

Self Management ◽

Controlled Study ◽

Control Group ◽

Problem Solving Skills ◽

Randomised Controlled

IntroductionThe eHealth technologies that are being designed for chronic disease constitute a global trend towards health assessment and self-management. However, most of these approaches tend to focus on a single symptom or problem rather than on the multiple problems that are characteristic of many of these chronic illnesses. The aim of this study is to examine the effectiveness of and adherence to a self-management application (app) that identifies multiple problem areas related to surviving breast cancer as the targeted chronic illness.Methods and analysisThis is a randomised controlled study. Eligible participants will be allocated randomly into either an intervention group or a control group at a 1:1 ratio. The intervention group will be assigned to the self-management app (‘Be-with-You’), while the control group will use a general health app (‘Sham’ app). The primary outcomes will include the differences between the two groups in their health literacy, problem-solving skills and self-management skills. The secondary outcomes will include group differences in self-efficacy, readiness for change and health-related quality of life. All of these outcomes will be measured at baseline and at 4 weeks and 12 weeks after intervention. In addition, usability of these two mobile apps will be measured at 4 weeks and 12 weeks after intervention. The planned sample size is 476.Ethics and disseminationThe Human Subjects Ethics Sub-committee of The Hong Kong Polytechnic University approved the study (HSEARS20190922001, 24 September 2019). Dissemination of findings will occur at the local, national and international levels.Trial registration numberChiCTR1900026244.

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Nursing appointment and cardiometabolic control of diabetics: a randomized clinical trial

Revista Brasileira de Enfermagem ◽

10.1590/0034-7167-2016-0352 ◽

2017 ◽

Vol 70 (3) ◽

pp. 468-474 ◽

Cited By ~ 1

Author(s):

Elen Ferraz Teston ◽

Guilherme Oliveira de Arruda ◽

Catarina Aparecida Sales ◽

Deise Serafim ◽

Sonia Silva Marcon

Keyword(s):

Low Cost ◽

Controlled Trial ◽

Control Group ◽

Structured Interviews ◽

Phone Calls ◽

Significant Difference ◽

Before And After ◽

And Control ◽

Cardiometabolic Profile

ABSTRACT Objective: to verify the effect of nursing appointment on cardiometabolic profile of people with Diabetes Mellitus type 2. Method: randomized controlled trial, developed with 134 individuals chosen for two groups: intervention and control. The intervention consisted of three nursing appointments alternated bimonthly, with two phone calls, over five months. The control group received usual care offered by the Health Unit. Data were collected through semi-structured interviews before and after the intervention, in addition to conducting laboratory tests. Results: after the intervention, a significant difference was shown in the amount of glycated hemoglobin (p = 0.006) and in the systolic blood pressure (p = 0.031), which were higher in the control group. Conclusion: besides being low-cost and easy to develop on the monitoring routine of people with diabetes, the intervention performed influenced positively the biochemical profile.

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Contextual Influences Experienced by Queensland Midwives: A Qualitative Study Focusing on Alcohol and Other Substance Use During Pregnancy

International Journal of Childbirth ◽

10.1891/2156-5287.9.2.80 ◽

2019 ◽

Vol 9 (2) ◽

pp. 80-91 ◽

Cited By ~ 1

Author(s):

Rosie Whitehead ◽

Frances O'Callaghan ◽

Jenny Gamble ◽

Natasha Reid

Keyword(s):

Maternity Care ◽

Critical Realism ◽

Contextual Factors ◽

Implementation Strategies ◽

System Level ◽

Organizational Level ◽

Structured Interviews ◽

Building Relationships ◽

Patient Level ◽

Communication Time

PURPOSETo understand the experiences and contextual factors that influence the ability of midwives to provide appropriate support to women regarding alcohol and other drug (AOD)e use during pregnancy, in the Queensland context.DESIGNUsing a qualitative approach underpinned by critical realism, we explored the experiences of eleven midwives using semi-structured interviews. Thematic analysis was utilized, which was inductive and deductive, as it aimed to explicate different contextual factors at play, based on the experiences of the current sample of midwives.MAJOR FINDINGSExperiences of midwives in the current study were influenced by five overarching contextual factors: (a) patient-level factors (complexities experienced by women and lack of knowledge regarding maternity care options); (b) provider/patient-level factors (importance of midwives building relationships with women and importance of continuity of care); (c) provider-level factors (importance of taking a supportive approach, midwife confidence, engagement in AOD screening, variable attitudes and knowledge); (d) organizational-level factors (lack of support and training, concerns regarding communication, time constraints and organizations that limited midwife involvement); (e) broader system-level factors (lack of effective services and inconsistent messages regarding AOD use during pregnancy).CONCLUSIONSThe current study has highlighted a range of practice areas and potential implementation strategies across a number of contextual levels that could be beneficial in the Queensland context to improve maternity care provision for women who are experiencing AOD use challenges during pregnancy.

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Perceived study-induced influence on the control group in a randomized controlled trial evaluating a complex intervention to promote psychosocial well-being after stroke: a process evaluation

Trials ◽

10.1186/s13063-021-05765-w ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Margrete Mangset ◽

Gabriele Kitzmüller ◽

Anne S. Evju ◽

Sanne Angel ◽

Lena Aadal ◽

...

Keyword(s):

Usual Care ◽

Controlled Trial ◽

Complex Interventions ◽

Well Being ◽

Safety Net ◽

Adjustment Process ◽

Control Group ◽

Structured Interviews ◽

Rehabilitation Research ◽

Main Challenge

Abstract Background A commonly applied control condition in trials evaluating complex interventions in rehabilitation research is “usual care.” The main challenge is to ensure that the control group receives genuine usual care as delivered in everyday clinical practice. The assessment interviews and dialogues with the data collectors may influence the control group participants’ reflections on their condition and adjustments. This represents a threat to the internal validity of the trial. Thus, the aim of this study was to explore the perceived study-induced influence of assessment interviews on the adjustment of the members of a control group in a randomized clinical trial. The aim of the trial was to test a dialogue-based psychosocial intervention aiming at promoting the psychosocial well-being and adjustment of stroke survivors. Methods Fifteen participants in the control group of a multicenter stroke rehabilitation trial participated in narrative semi-structured interviews. Ricoeur’s interpretation theory guided the analysis. Results The perceived study-induced influence of the assessment interviews on the adjustment process of members of the control group varied considerably. The results demonstrated that the assessment interviews facilitated some participants’ feelings of control and their ability to cope. Other participants’ statements indicate that they relied on their existing personal capacity to cope and adjust and that the assessment interviews did not make any difference either on their coping ability or on their process of adjustment. Five themes were identified that described the perceived study-induced influence of the assessment interviews in the control group. The themes illustrated that the assessments served as a safety net, enhanced awareness and understanding, encouraged seeking support, allowed the opportunity to vent disappointment, or did not make any difference either way. Conclusions RCT assessment interviews may influence the adjustment process and represent a serious problem in measuring interventions over time in trials of complex interventions in rehabilitation research. To uphold rigor and stringency, the usual care control conditions should be thoroughly assessed and described. Informing participants only about the treatment they were allocated to receive might counteract the potential to dilute the difference between the two arms of the trial. Trial registration ClinicalTrials.gov NCT02338869. Registered on October 4, 2014

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Does a simple web-based intervention facilitate the articulation of patients’ unvoiced agenda for a consultation with their diabetologists? A qualitative study

BMJ Open ◽

10.1136/bmjopen-2018-026588 ◽

2019 ◽

Vol 9 (6) ◽

pp. e026588 ◽

Cited By ~ 1

Author(s):

Julia Frost ◽

Andy Gibson ◽

Obioha Ukoumunne ◽

Bijay Vaidya ◽

Nicky Britten

Keyword(s):

Decision Making ◽

Qualitative Study ◽

Shared Decision Making ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Shared Decision ◽

Structured Interviews ◽

Web Based ◽

Patients With Diabetes

ObjectiveTo explore whether a preconsultation web-based intervention enables patients with diabetes to articulate their agenda in a consultation in the hospital outpatient clinic with their diabetologist.Methods and designA qualitative study embedded in a pragmatic pilot randomised controlled trial.SettingTwo city outpatient departments in England.Participants25 patients attending a follow-up consultation and 6 diabetologists.InterventionThe PACE-D, a web-based tool adapted for patients with diabetes to use before their consultation to generate an agenda of topics to discuss with their diabetologist.Data collection25 participants had their consultation with their diabetologist audio-recorded: 12 in the control arm and 13 in the intervention arm; 12 of the latter also had their PACE-D intervention session and a consultation recorded. Semi-structured interviews with 6 diabetologists, and 12 patients (6 in the intervention group and 6 in the control group).AnalysisThematic discourse analysis undertaken with patient representatives trained in qualitative data analysis techniques.ResultsWe identified four consultation types: diabetologist facilitated; patient identified; consultant facilitated and patient initiated and patient ignored. We also identified three critical aspects that explained the production and utilisation of the agenda form: existing consultative style; orientation to the use of the intervention and impact on the consultation. Where patients and diabetologists have a shared preference for a consultant-led or patient-led consultation, the intervention augments effective communication and shared decision making. However, where preferences diverge (eg, there is a mismatch in patients' and diabetologists' preferences and orientations), the intervention does not improve the potential for shared decision making.ConclusionA simple web-based intervention facilitates the articulation of patients’ unvoiced agenda for a consultation with their diabetologist, but only when pre-existing consultation styles and orientations already favour shared decision making. More needs to be done to translate patient empowerment in the consultation setting into genuine self-efficacy.Trial registration numberISRCTN75070242.

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ADOPTION PROCESSES FOR EDM, EDI AND BIM TECHNOLOGIES IN THE CONSTRUCTION INDUSTRY

Journal of Civil Engineering and Management ◽

10.3846/13923730.2013.801888 ◽

2014 ◽

Vol 19 (Supplement_1) ◽

pp. S172-S187 ◽

Cited By ~ 13

Author(s):

Olle Samuelson ◽

Bo-Christer Björk

Keyword(s):

Construction Industry ◽

Integrated Design ◽

3D Models ◽

Organizational Level ◽

Survey Study ◽

Adoption Process ◽

It Adoption ◽

Structured Interviews ◽

Individual Level ◽

Adoption Theory

Three strategically important uses of IT in the construction industry are management of project documents on webservers (EDM), electronic handling of orders and invoices between companies (EDI) and use of 3D models including non-geometrical attributes for integrated design and construction (BIM). The purpose of this work is to study factors that affect the decisions to implement these techniques as well as the actual adoption process. In a longitudinal survey study in the Swedish Construction Industry, the extent of use of these techniques was measured in 1998, 2000 and 2007. This paper presents a follow-up to the quantitative studies, where semi-structured interviews have been used, in a qualitative approach. The theoretical basis for the studies was informed by frameworks from IT-adoption theory. The results showed that decisions to implement these technologies are made on three different levels: individual level, company organizational level, and project organizational level. Different patterns in adoption can be explained by where decisions are mainly taken. EDM is driven from the project level, EDI mainly from the company level, and BIM is driven by individuals. The study points out that decision for implementing BIM should be taken on a higher strategic level in order to deliver intended benefits.

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A Web-Based Multidomain Lifestyle Intervention for Older Adults: The eMIND Randomized Controlled Trial

Journal of Prevention of Alzheimer's Disease ◽

10.14283/jpad.2020.70 ◽

2020 ◽

pp. 1-9 ◽

Cited By ~ 1

Author(s):

P. de Souto Barreto ◽

K. Pothier ◽

G. Soriano ◽

M. Lussier ◽

L. Bherer ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Training ◽

Controlled Trial ◽

Intervention Group ◽

Community Dwelling ◽

Control Group ◽

Structured Interviews ◽

Subjective Memory ◽

Web Based ◽

Randomized Controlled

Importance/Objective: To describe the feasibility and acceptability of a 6-month web-based multidomain lifestyle training intervention for community-dwelling older people and to test the effects of the intervention on both function- and lifestyle-related outcomes. Design: 6-month, parallel-group, randomized controlled trial (RCT). Setting: Toulouse area, South-West, France. Participants: Community-dwelling men and women, ≥ 65 years-old, presenting subjective memory complaint, without dementia. Intervention: The web-based multidomain intervention group (MIG) received a tablet to access the multidomain platform and a wrist-worn accelerometer measuring step counts; the control group (CG) received only the wrist-worn accelerometer. The multidomain platform was composed of nutritional advices, personalized exercise training, and cognitive training. Main outcomes and measures: Feasibility, defined as the proportion of people connecting to ≥75% of the prescribed sessions, and acceptability, investigated through content analysis from recorded semi-structured interviews. Secondary outcomes included clinical (eg, cognitive function, mobility, health-related quality of life (HRQOL)) and lifestyle (eg, step count, food intake) measurements. Results: Among the 120 subjects (74.2 ±5.6 years-old; 57.5% women), 109 completed the study (n=54, MIG; n=55, CG). 58 MIG subjects connected to the multidomain platform at least once; among them, adherers of ≥75% of sessions varied across multidomain components: 37 people (63.8% of 58 participants) for cognitive training, 35 (60.3%) for nutrition, and three (5.2%) for exercise; these three persons adhered to all multidomain components. Participants considered study procedures and multidomain content in a positive way; the most cited weaknesses were related to exercise: too easy, repetitive, and slow progression. Compared to controls, the intervention had a positive effect on HRQOL; no significant effects were observed across the other clinical and lifestyle outcomes. Conclusions and Relevance: Providing multidomain lifestyle training through a web-platform is feasible and well-accepted, but the training should be challenging enough and adequately progress according to participants’ capabilities to increase adherence. Recommendations for a larger on-line multidomain lifestyle training RCT are provided.

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Goal Attainment and Treatment Compliance in a Cognitive-Behavioral Telephone Intervention for Family Caregivers of Persons with Dementia

GeroPsych ◽

10.1024/1662-9647/a000043 ◽

2011 ◽

Vol 24 (3) ◽

pp. 115-125 ◽

Cited By ~ 18

Author(s):

Gabriele Wilz ◽

Denise Schinköthe ◽

Renate Soellner

Keyword(s):

Family Caregivers ◽

Mentally Ill ◽

Goal Attainment ◽

Outcome Measurement ◽

Controlled Trial ◽

Treatment Success ◽

Treatment Compliance ◽

Control Group ◽

Telephone Intervention ◽

Effective Interventions

Introduction: The evaluation of effective interventions is still needed to prevent family caregivers of persons with dementia from becoming physically or mentally ill. However, in most existing intervention studies, primary outcomes are not well matched to the treatment goals. Method: A randomized controlled trial (N = 229) was conducted to compare a treatment group (CBT), a treated control group, and an untreated control group. In theses analyses we focused on the primary outcome measurement (GAS) as a perceived treatment success as well as treatment compliance and participants’ evaluation. Results: Results showed that 30.1% achieved complete goal attainment, 39.8% partial goal attainment, and 24.1% declared no change (overachievement 2.4%; deterioration 3.6%). Discussion: The intervention can be considered to have been successful.

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Promoting the Community's Ability to Detect and Respond to Suicide Risk Through an Online Bystander Intervention Model-Informed Tool

Crisis ◽

10.1027/0227-5910/a000708 ◽

2020 ◽

pp. 1-7

Author(s):

Karien Hill ◽

Shawn Somerset ◽

Ralf Schwarzer ◽

Carina Chan

Keyword(s):

Suicide Prevention ◽

Suicide Risk ◽

Controlled Trial ◽

Intervention Group ◽

Bystander Intervention ◽

Self Report ◽

Innovative Technology ◽

Control Group ◽

Intervention Model ◽

Standard Material

Abstract. Background: The public health sector has advocated for more innovative, technology-based, suicide prevention education for the community, to improve their ability to detect and respond to suicide risk. Emerging evidence suggests addressing the bystander effect through the Bystander Intervention Model (BIM) in education material may have potential for suicide prevention. Aims: The current study aimed to assess whether BIM-informed tools can lead to improved readiness, confidence and intent in the community to detect and respond to suicide risk in others. Method: A sample of 281 adults recruited from the community participated in a randomized controlled trial comprising a factsheet designed according to the BIM (intervention group) and a standard factsheet about suicide and mental health (control group). Participants' self-reported detecting and responding to suicide risk readiness, confidence, and intent when presented with a suicidal peer was tested pre- and postintervention and compared across time and between groups. Results: The intervention group had significantly higher levels of detecting and responding to suicide risk readiness, confidence, and intent than the control group at postintervention (all p < .001) with moderate-to-large effect sizes. Limitations: The study was limited by a homogenous sample, too low numbers at follow-up to report, and self-report data only. Conclusion: This study demonstrates BIM-informed suicide prevention training may enhance the community's intervention readiness, confidence, and intent better than current standard material. Further testing in this area is recommended. While results were statistically significant, clinical significance requires further exploration.

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