Project Concept Review
Council Date: June 7, 2019
Program Officer: Lanay M. Mudd, Ph.D.
To achieve the National Center for Complementary and Integrative Health (NCCIH) mission of defining the usefulness and safety of complementary and integrative health interventions and their roles in preventing disease, improving health, and managing symptoms, NCCIH supports clinical trial research to develop and test the safety, efficacy, and effectiveness of these approaches. Funding opportunities are available to collect feasibility and acceptability data, refine an intervention and determine multisite feasibility, and conduct appropriately powered multisite efficacy or effectiveness trials.
Increasingly, researchers are incorporating mHealth technologies to remotely deliver interventions, including mindfulness, deep breathing, progressive muscle relaxation, and other complementary and integrative health interventions. These mHealth and remotely delivered interventions may utilize app-based approaches, video delivery, web-based platforms, wearable devices and new technologies. The rapid expansion of mHealth technologies makes it possible to transmit participant data digitally from remote areas to centrally based researchers and interventionists, deliver feedback, and capture all interactions in a database. The use of mHealth and remotely delivered interventions has the potential to increase the reach of complementary and integrative health interventions, and many commercially available approaches already exist. However, rigorously designed research is needed to test the usefulness and safety of these approaches.
NCCIH currently requires multiple clinical sites and an independent data coordinating center for large-scale clinical trials to enhance rigor and improve the generalizability of findings through our NCCIH-specific clinical trial funding opportunities. However, such an approach is not needed for remotely delivered mHealth interventions as a single site could conduct nationwide recruitment. In addition, research on mHealth and remotely delivered interventions could not be considered through parent R-mechanisms as NCCIH only allows mechanistic clinical trials to be considered for funding through these mechanisms. Therefore, NCCIH currently does not have a way of supporting research on mHealth and remotely delivered interventions.
Purpose of Proposed Program
The purpose of the proposed initiative is to support research to test and/or compare mHealth tools/technologies and fully remotely delivered complementary and integrative health interventions. Supported research utilizing these methods of delivery would also align with NCCIH’s Strategic Plan, in particular, Objective 2: Improve Care for Hard-to-Manage Symptoms and Objective 3: Foster Health Promotion and Disease Prevention. This initiative also aligns with an NCCIH top Scientific Priority to support clinical trials using innovative study designs.
The objectives to be met by this initiative are well aligned with NCCIH’s Strategic Plan and include, but are not limited to, the following:
- Support rigorous research testing mHealth tools/technologies and remotely delivered complementary and integrative health interventions
- Generate generalizable and easily scalable results on mHealth and remotely delivered complementary and integrative health interventions
- Promote research that extends the reach of complementary and integrative health interventions by using mHealth tools/technologies.