Self-management open online trials in health [SMOOTH] an analysis of existing online trials [Protocol]

BACKGROUND: The use of public engagement and self-management in online clinical trials is growing with benefits, boundaries and minimal methodological guidance. This analysis explores whether running self-recruited online trials can provide trustworthy and useful answers to research questions. AIM: To systematically explore existing self-recruited online randomized controlled trials of self-management interventions and analyze the trials to assess their strengths and weaknesses, the quality of trials reporting and to report how participants were involved in the research process. METHODS: The Online Randomized Controlled Trials of Health Information Database (ORCHID) will be used as a sampling framework to identify a subset of self-management self-recruited interventions. The trials will be used to explore the qualities of self-recruited online randomized controlled trials and to evaluate how useful they are for obtaining trustworthy answers to questions about health self-management and citizen research involvement. This research employs participatory action research where researchers and participants work as collaborators. SUMMARY: This analysis can provide an overall view of effective methods for online trials and to provide insights into integration for online trials development as early as the protocol planning stage.

Download Full-text

Digital Self-Management Support Tools in the Care Plan of Patients With Cancer: Review of Randomized Controlled Trials

Journal of Medical Internet Research ◽

10.2196/20861 ◽

2021 ◽

Vol 23 (6) ◽

pp. e20861

Author(s):

Danielle JM Adriaans ◽

Angelique TM Dierick-van Daele ◽

Marc Johannes Hubertus Maria van Bakel ◽

Grard AP Nieuwenhuijzen ◽

Joep AW Teijink ◽

...

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Randomized Controlled Trials ◽

Self Management ◽

Controlled Trials ◽

Management Support ◽

Patients With Cancer ◽

Randomized Controlled ◽

Support Tools

Background Digital self-management support tools (DSMSTs)—electronic devices or monitoring systems to monitor or improve health status—have become increasingly important in cancer care. Objective The aim of this review is to analyze published randomized clinical trials to assess the effectiveness of DSMSTs on physical and psychosocial symptoms or other supportive care needs in adult patients with cancer. Methods Five databases were searched from January 2013 to January 2020. English or Dutch language randomized controlled trials comparing DSMSTs with no intervention, usual care, alternative interventions, or a combination and including patients aged ≥18 years with pathologically proven cancer in the active treatment or survivorship phases were included. The results were summarized qualitatively. Results A total of 19 publications describing 3 types of DSMSTs were included. Although the content, duration, and frequency of interventions varied considerably across studies, the commonly used elements included an assessment component, tailored symptom self-management support, an information section, a communication section, and a diary. Significant positive effects were observed on quality of life in 6 (out of 10) studies, on anxiety in 1 (out of 5) study and depression in 2 (out of 8) studies, on symptom distress in 5 (out of 7) studies, on physical activity in 4 (out of 6) studies, on dietary behavior in 1 (out of 4) study, and on fatigue in 2 (out of 5) studies. Moreover, significant negative effects were observed on anxiety in 1 (out of 5) study and depression in 1 (out of 8) study. Most interventions were web-based interventions; 2 studies used mobile apps, and 1 study used a game as a DSMST. The overall quality of the studies was found to be good, with 13 out of 19 studies classified as high quality. Conclusions This review suggests that DSMSTs have a beneficial effect on the quality of life. For effects on other patient outcomes (eg, anxiety and depression, symptom distress, physical activity, dietary behavior, and fatigue), the evidence is inconsistent and limited or no effect is suggested. Future research should focus on specific tumor types, study different types of interventions separately, and assess the effects of specific interventions at different stages of disease progression.

Download Full-text

Efficacy of web-based self-management interventions for depressive symptoms: a meta-analysis of randomized controlled trials

BMC Psychiatry ◽

10.1186/s12888-021-03396-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Yue Pang ◽

Xin Zhang ◽

Ruitong Gao ◽

Linqi Xu ◽

Meidi Shen ◽

...

Keyword(s):

Depressive Symptoms ◽

Randomized Controlled Trials ◽

Meta Analysis ◽

Self Management ◽

Control Group ◽

Controlled Trials ◽

Cochrane Central Register ◽

Web Based ◽

Randomized Controlled ◽

Management Interventions

Abstract Background The incidence of depression is increasing worldwide. Depression can lead to poor physical health and even suicide. However, in high-income countries, only about 50% of the people with depression receive appropriate therapy, and the detection rate of depression in low- and middle-income countries is relatively lower. Web-based self-management enables remote treatment and solves the problem of insufficient psychological treatment resources. Many past studies have evaluated the effectiveness of web-based self-management of depression, but there has been no synthesis of evidence. Therefore, this study conducted a meta-analysis of the effectiveness of web-based self-management for depressive symptoms. Method Six electronic databases (Cochrane Central Register of Controlled Trials, PubMed, Web of Science, Embase, CINAHL, and PsycINFO) were searched in September 2020. All literature referring to the effects of web-based self-management on depression were shortlisted by performing the medical subject headings (MeSH) search combined with a text word search. Results A total of 18 eligible randomized controlled trials were identified, and the results from 3055 participants were consolidated. The web-based self-management group exhibited a greater reduction in depressive symptoms than the control group (g = − 0.46; 95% CI: 0.62,0.30), and there was no evidence of publication bias. Subgroup analysis revealed that patients with moderate-to-severe depression benefited from web-based self-management interventions. In terms of interventions, those based on cognitive behavioral therapy (CBT) were highly effective. We noted that the longer the intervention time, the better was the improvement in the status of depression. Furthermore, it was established that participants who communicated with therapists and showed greater adherence to the intervention experienced significant improvement in their symptoms. The results of the intervention group were better than those of the waiting-list, treatment-as-usual, and online psychoeducation groups. Conclusions Web-based self-management is a promising therapy for depression. Future research should aim to refine these aspects of the intervention to achieve a beneficial impact.

Download Full-text

Digital Self-Management Support Tools in the Care Plan of Patients With Cancer: Review of Randomized Controlled Trials (Preprint)

10.2196/preprints.20861 ◽

2020 ◽

Author(s):

Danielle JM Adriaans ◽

Angelique TM Dierick-van Daele ◽

Marc Johannes Hubertus Maria van Bakel ◽

Grard AP Nieuwenhuijzen ◽

Joep AW Teijink ◽

...

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Randomized Controlled Trials ◽

Self Management ◽

Controlled Trials ◽

Management Support ◽

Patients With Cancer ◽

Randomized Controlled ◽

Support Tools

BACKGROUND Digital self-management support tools (DSMSTs)—electronic devices or monitoring systems to monitor or improve health status—have become increasingly important in cancer care. OBJECTIVE The aim of this review is to analyze published randomized clinical trials to assess the effectiveness of DSMSTs on physical and psychosocial symptoms or other supportive care needs in adult patients with cancer. METHODS Five databases were searched from January 2013 to January 2020. English or Dutch language randomized controlled trials comparing DSMSTs with no intervention, usual care, alternative interventions, or a combination and including patients aged ≥18 years with pathologically proven cancer in the active treatment or survivorship phases were included. The results were summarized qualitatively. RESULTS A total of 19 publications describing 3 types of DSMSTs were included. Although the content, duration, and frequency of interventions varied considerably across studies, the commonly used elements included an assessment component, tailored symptom self-management support, an information section, a communication section, and a diary. Significant positive effects were observed on quality of life in 6 (out of 10) studies, on anxiety in 1 (out of 5) study and depression in 2 (out of 8) studies, on symptom distress in 5 (out of 7) studies, on physical activity in 4 (out of 6) studies, on dietary behavior in 1 (out of 4) study, and on fatigue in 2 (out of 5) studies. Moreover, significant negative effects were observed on anxiety in 1 (out of 5) study and depression in 1 (out of 8) study. Most interventions were web-based interventions; 2 studies used mobile apps, and 1 study used a game as a DSMST. The overall quality of the studies was found to be good, with 13 out of 19 studies classified as <i>high quality</i>. CONCLUSIONS This review suggests that DSMSTs have a beneficial effect on the quality of life. For effects on other patient outcomes (eg, anxiety and depression, symptom distress, physical activity, dietary behavior, and fatigue), the evidence is inconsistent and limited or no effect is suggested. Future research should focus on specific tumor types, study different types of interventions separately, and assess the effects of specific interventions at different stages of disease progression.

Download Full-text