Five Lessons Learned From Randomized Controlled Trials on Mobile Health Interventions: Consensus Procedure on Practical Recommendations for Sustainable Research

Pach, Daniel; Rogge, Alizé A; Wang, Jiani; Witt, Claudia M.

doi:10.2196/20630

Cited by 5 publications

(5 citation statements)

References 22 publications

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“…Mobile applications are readily developed and can provide accurate data to track participant engagement and progress, but more formal testing is needed. 64 Surprisingly, the majority of remotely delivered movement CIH (i.e., yoga, qigong , Pilates, Tai Chi, massage, hypnosis) used CD/DVDs as opposed to the more adaptable mobile application. CD/DVDs may be the VHR of choice for these CIH as they may be played on a television screen that is largely visible even when in varied positions required for a movement practice.…”

Section: Discussionmentioning

confidence: 99%

Delivery of Complementary and Integrative Health Using Virtual Health Resources: A Scoping Review

Haun

Alman

Jean-Baptiste

et al. 2022

Journal of Integrative and Complementary Medicine

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Introduction: Complementary and integrative health (CIH) modalities promote overall health and well-being and can be beneficial for individuals with a range of conditions. Traditionally, CIH has been delivered in person. COVID-19 created a need to identify sustainable remote delivery options to assure access to CIH while practicing public health recommendations. This scoping review maps the opportunities and challenges to remotely delivered CIH. Materials and methods: A scoping review was conducted between June 2020 and October 2020 using the following search engines: PubMed, Academic Search Premier, PsycINFO, CINAHL, Cochrane Reviews, and the Cochrane Clinical Trial Collections. Search results investigating remote CIH delivery were restricted to articles written in English, published after 1990. Results: Of the 10,884 articles identified, after review for content and methods, 330 articles were included. Most articles were randomized controlled trials ( n = 170), applied mindfulness ( n = 203), and targeted mental and behavioral health conditions ( n = 182). Interventions were primarily delivered through mobile applications ( n = 151) and web-based platforms ( n = 86). Most commonly reported barriers were adherence ( n = 24), resource requirements (e.g., time and space) ( n = 23), and technology-related issues ( n = 21). Although most studies did not report facilitators ( n = 217), most commonly reported facilitators were social and technologic supports, accessibility, usability, perceptions, and rewards. Participant outcomes measured were broad and included movement ( n = 88), stress ( n = 68), and pain ( n = 54). Intervention characteristic outcomes most often measured were satisfaction and usability ( n = 5). Conclusions: This scoping literature review identified many articles addressing remote delivery of CIH, but few reporting on the implementation of remotely delivered CIH. Findings suggest remotely delivered CIH, specifically mindfulness and meditation-based modalities, is a viable treatment option for a diverse range of health conditions. Feasibility studies and larger sample sizes are recommended to strengthen the scientific evidence.

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Section: Discussionmentioning

confidence: 99%

Delivery of Complementary and Integrative Health Using Virtual Health Resources: A Scoping Review

Haun

Alman

Jean-Baptiste

et al. 2022

Journal of Integrative and Complementary Medicine

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“…Other barriers may be at the design level. Poor acceptability due to low ease of use, high design complexity and design mismatch with the real-world context of the end users are some challenges reported for mHealth interventions [ 13 , 40 , 41 ]. Agile software development and user centred design have been demonstrated as useful approaches to improve acceptability of mHealth platforms in recent implementation research literature [ 40 , 42 – 44 ].…”

Section: Discussionmentioning

confidence: 99%

Operational challenges in the pre-intervention phase of a mental health trial in rural India: reflections from SMART Mental Health

Mukherjee

Daniel²,

Kaur³

et al. 2022

Int J Ment Health Syst

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Background Availability of mental health services in low- and middle-income countries is largely concentrated in tertiary care with limited resources and scarcity of trained professionals at the primary care level. SMART Mental Health is a strategy that combines a community anti-stigma campaign with a primary health care workforce strengthening initiative, using electronic decision support with the goal of better identifying and supporting people with common mental disorders in India. Methods We describe the challenges faced and lessons learnt during the pre-intervention phase of SMART Mental Health cluster Randomised Controlled Trial. Pre-intervention phase includes preliminary activities for setting-up the trial and research activities prior to delivery of the intervention. Field notes from project site visit, project team meetings and detailed follow-up discussions with members of the project team were used to document operational challenges and strategies adopted to overcome them. The socio-ecological model was used as the analytical framework to organise the findings. Results Key challenges included delays in government approvals, addressing community health worker needs, and building trust in the community. These were addressed through continuous communication, leveraging support of relevant stakeholders, and addressing concerns of community health workers and community. Issues related to use of digital platform for data collection were addressed by a dedicated technical support team. The COVID-19 pandemic and political unrest led to significant and unexpected challenges requiring important adaptations to successfully implement the project. Conclusion Setting up of this trial has posed challenges at a combination of community, health system and broader socio-political levels. Successful mitigating strategies to overcome these challenges must be innovative, timely and flexibly delivered according to local context. Systematic ongoing documentation of field-level challenges and subsequent adaptations can help optimise implementation processes and support high quality trials. Trial registration: The trial is registered with Clinical Trials Registry India (CTRI/2018/08/015355). Registered on 16th August 2018. http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=23254&EncHid=&userName=CTRI/2018/08/015355

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“… 67 However, it is indispensable to take into account limitations, barriers and needs of the target population to better adapt devices and interventions. 68 , 69 One of the main barriers to older people using mobile technology and devices should be as simple as possible and if applicable, easy to wear. 68 Motivational behavior change techniques should be used to improve engagement with interventions 69 and therefore efficacy.…”

Section: Discussionmentioning

confidence: 99%

“… 68 , 69 One of the main barriers to older people using mobile technology and devices should be as simple as possible and if applicable, easy to wear. 68 Motivational behavior change techniques should be used to improve engagement with interventions 69 and therefore efficacy. Moreover, to improve engagement and digital literacy, a session to explain how to use study device with trained-staff is recommended.…”

Section: Discussionmentioning

confidence: 99%

Telephone and Smartphone-Based Interventions for Cognitive and Cardio-Metabolic Health in Middle-Aged and Older Adults: A Systematic Review

Andre¹,

Giulioli²,

Piau³

et al. 2022

CIA

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Dementia and cardio-metabolic diseases share many risk factors. Management of these risk factors could contribute to successful aging, including the prevention of cardio-metabolic disease and dementia. The increasing use of smartphones offers an opportunity for remote preventive interventions. We provided a systematic review of telephone and smartphone-based interventions targeting the prevention of cognitive decline, dementia cardio-metabolic diseases or their risk factors among adults aged over 50 years. Patients and Methods: We searched Pubmed and the International Clinical Trials Registry Platform for experimental studies. We used the Cochrane risk-of-bias tool (Version 2) for randomized trials or TREND (Transparent Reporting of Evaluations with Nonrandomized Designs) checklists to assess study quality for completed studies. Results: We analyzed 21 completed (3 for cognition, 18 for cardio-metabolic outcomes) and 50 ongoing studies (23 for cognition, 27 for cardio-metabolic outcomes). Smartphone interventions were used in 26 studies (3 completed, 23 ongoing). Other interventions involved telephone vocal support and text messaging. Few studies were at low risk of bias. There were heterogeneous cognitive and cardio-metabolic outcomes. The highest quality studies found no significant effects on cognition, and inconsistent results for HbA1c, blood pressure or physical activity. The lower quality-studies found effects on global cognition, working memory, memory and language and inconsistent results for clinical, biological or behavioral cardio-metabolic outcomes. Conclusion and Implications:Despite the large number of commercially available mobile health applications, the magnitude of the scientific evidence base remains very limited. Based on published studies, the added value of telephone and smartphone tools for the prevention of cardio-metabolic diseases, cognitive decline or dementia is currently uncertain, but, there are several ongoing studies expected to be completed in the coming years.

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Five Lessons Learned From Randomized Controlled Trials on Mobile Health Interventions: Consensus Procedure on Practical Recommendations for Sustainable Research

Cited by 5 publications

References 22 publications

Delivery of Complementary and Integrative Health Using Virtual Health Resources: A Scoping Review

Delivery of Complementary and Integrative Health Using Virtual Health Resources: A Scoping Review

Operational challenges in the pre-intervention phase of a mental health trial in rural India: reflections from SMART Mental Health

Telephone and Smartphone-Based Interventions for Cognitive and Cardio-Metabolic Health in Middle-Aged and Older Adults: A Systematic Review

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