Implementing a Self-Management Intervention for People with a Chronic Compensable Musculoskeletal Injury in a Workers Compensation Context: A Process Evaluation

Abstract Background Process evaluations have become a valued component, alongside clinical trials, of the wider evaluation of complex health interventions. They support understanding of implementation, and fidelity, related to the intervention and provide valuable insights into what is effective in a practical setting by examining the context in which interventions are implemented. The TOPSY study consists of a large multi-centre randomised controlled trial comparing the effectiveness of pessary self-management with clinic-based care in improving women’s condition-specific quality of life, and a nested process evaluation. The process evaluation aims to examine and maximise recruitment to the trial, describe intervention fidelity and explore participants’ and healthcare professionals’ experiences. Methods The trial will recruit 330 women from approximately 17 UK centres. The process evaluation uses a mixed-methods approach. Semi-structured interviews will be conducted with randomised women (18 per randomised group/n = 36), women who declined trial participation but agreed to interview (non-randomised women) (n = 20) and healthcare professionals recruiting to the trial (n ~ 17) and delivering self-management and clinic-based care (n ~ 17). The six internal pilot centres will be asked to record two to three recruitment discussions each (total n = 12–18). All participating centres will be asked to record one or two self-management teaching appointments (n = 30) and self-management 2-week follow-up telephone calls (n = 30). Process data (quantitative and qualitative) will be gathered in participant completed trial questionnaires. Interviews will be analysed thematically and recordings using an analytic grid to identify fidelity to the intervention. Quantitative analysis will be predefined within the process evaluation analysis plan. Discussion The wide variety of pessary care delivered across the UK for women with pelvic organ prolapse presents specific localised contexts in which the TOPSY interventions will be implemented. Understanding this contextual variance is central to understanding how and in what circumstances pessary self-management can be implemented (should it be effective). The inclusion of non-randomised women provides an innovative way of collecting indispensable information about eligible women who decline trial participation, allowing broader contextualisation and considerations of generalisability of trial findings. Methodological insights from examination of recruitment processes and mechanisms have the potential to inform recruitment mechanisms and future recruitment strategies and study designs. Trial registration ISRCTN62510577. Registered on 6 October 2017.

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Process evaluation of a multi-component self-management intervention for adults with epilepsy (ZMILE study)

Epilepsy & Behavior ◽

10.1016/j.yebeh.2017.05.023 ◽

2017 ◽

Vol 73 ◽

pp. 64-70 ◽

Cited By ~ 6

Author(s):

Loes A.M. Leenen ◽

Ben F.M. Wijnen ◽

Jolanda C.M. van Haastregt ◽

Reina J.A. de Kinderen ◽

Silvia M.A.A. Evers ◽

...

Keyword(s):

Process Evaluation ◽

Self Management ◽

Management Intervention

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A Randomized Trial of Self-Management Intervention for Chronic Fatigue Syndrome in Primary Care

PsycEXTRA Dataset ◽

10.1037/e656742011-001 ◽

2011 ◽

Author(s):

Fred Friedberg

Keyword(s):

Primary Care ◽

Chronic Fatigue Syndrome ◽

Randomized Trial ◽

Chronic Fatigue ◽

Self Management ◽

Management Intervention ◽

Fatigue Syndrome

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The SEA CHANGE Study: A Self Management Intervention for Head and Neck Cancer Survivors

Case Medical Research ◽

10.31525/ct1-nct04051697 ◽

2019 ◽

Author(s):

Keyword(s):

Head And Neck Cancer ◽

Cancer Survivors ◽

Head And Neck ◽

Neck Cancer ◽

Self Management ◽

Management Intervention

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Feasibility of an mHealth self-management intervention for children and adolescents with sickle cell disease and their families

Translational Behavioral Medicine ◽

10.1093/tbm/ibaa132 ◽

2021 ◽

Author(s):

Shannon Phillips ◽

Julie Kanter ◽

Martina Mueller ◽

Amy Gulledge ◽

Kenneth Ruggiero ◽

...

Keyword(s):

Sickle Cell Disease ◽

Sickle Cell ◽

Rating Scale ◽

Management Strategies ◽

Self Management ◽

Cell Disease ◽

Vessel Occlusion ◽

Feasibility Assessment ◽

Management Intervention ◽

Scale Scores

Abstract Sickle cell disease (SCD) is an inherited hemoglobinopathy that leads to blood vessel occlusion and multiorgan complications, including pain, that may be experienced daily. Symptom management often begins at home, and tools are needed to support self-management strategies that can be implemented by children with SCD and families. The purpose of this study was to assess the feasibility of the mHealth self-management intervention (application) Voice Crisis Alert V2 for children with SCD and families. Feasibility assessment was guided by the Reach, Efficacy, Adoption, Implementation, and Maintenance framework. Data were collected with 60 dyads (children with SCD/caregivers) at four time points. Self-management data were collected via application use, and postintervention interviews were conducted. Analyses included descriptive statistics and constant comparison with directed content analysis. Recruitment was completed in 28 weeks, with 82% retention at end-of-intervention. Mobile Application Rating Scale scores and interview data indicated high satisfaction. From baseline to mid-intervention, 94% of dyads used the application (75% of total use); 45% used the application from mid-intervention to the end-of-intervention. Dyads made 2,384 actions in the application; the most commonly used features were recording health history and recording and tracking symptoms. Few reported issues with the application; most issues occurred early in the study and were corrected. After the intervention period was completed, 37% continued to use the application. Feasibility was confirmed by meeting recruitment and retention goals, high adoption of the application, and high reported satisfaction with the application. Challenges with sustained use were encountered, and areas for improvement were identified.

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TEXT4myBACK – The development process of a self-management intervention delivered via text message for low back pain

Archives of Rehabilitation Research and Clinical Translation ◽

10.1016/j.arrct.2021.100128 ◽

2021 ◽

pp. 100128

Author(s):

Carolina G. Fritsch ◽

Paulo H. Ferreira ◽

Joanna L Prior ◽

Giovana Vesentini ◽

Patricia Schlotfeldt ◽

...

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Development Process ◽

Text Message ◽

Self Management ◽

Low Back ◽

Management Intervention

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The effectiveness of nurse-led self-management support program for people with chronic kidney disease stage 3-4 (CKD-NLSM): Study protocol for a randomized controlled trial

Science Progress ◽

10.1177/00368504211026159 ◽

2021 ◽

Vol 104 (2) ◽

pp. 003685042110261

Author(s):

Al Sawad Ayat Ali ◽

Soo Kun Lim ◽

Li Yoong Tang ◽

Aneesa Abdul Rashid ◽

Boon-How Chew

Keyword(s):

Kidney Disease ◽

Controlled Trial ◽

Self Management ◽

Control Group ◽

Management Support ◽

Disease Knowledge ◽

Management Intervention ◽

Randomized Controlled ◽

Ckd Stage ◽

Management Behaviors

The complexity of chronic kidney disease (CKD) and its treatments have made self-management behaviors inevitably challenging. However, supplementing education with self-management skills may improve numerous health outcomes in people with nondialysis CKD. This study protocol describes a randomized controlled trial (RCT) aimed to evaluate the effects of a nurse-led self-management support program as an intervention for kidney disease knowledge and CKD self-management behaviors among people with pre-dialysis CKD. In Phase 1, people with CKD stage 3–4 and their family members are involved in co-designing, development and pilot testing of a theory-based self-management intervention. In Phase 2, we perform a cross-cultural adaptation of the Kidney Disease Knowledge Survey, CKD Self-Management and Self-efficacy for Managing Chronic Disease questionnaires. In Phase 3, a parallel RCT will be conducted to evaluate the intervention where 154 participants with CKD stage 3–4 will be randomly assigned to either the intervention ( n = 77) or control group ( n = 77). The intervention group will receive 6-week self-management program from a nurse-coach in addition to standard usual care, while the control group will receive only standard usual care. Outcome measures include kidney disease knowledge, CKD self-management behavior, self-efficacy, quality of life, blood pressure control and adherence to CKD diet as indicated by 24-h urine urea nitrogen, 24-h urine sodium and net endogenous acid production. Data will be collected at baseline and 12-week post-baseline. The between- and within-group intervention effects will be estimated using the Generalized Estimating Equations. The self-management intervention offers strategies to delay CKD progression and to encourage motivation to better self-manage at home. This study integrates self-management education and psychosocial support with culturally relevant scenarios, and evaluates important self-reported and objective outcomes. Clinical Trials Registration: www.ClinicalTrials.gov , identifier: NCT03974646.

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