Study Design and Protocol of a Randomized Controlled Trial of the Efficacy of a Smartphone-Based Therapy of Migraine (SMARTGEM)

Gonçalves, Ana Sofia Oliveira; Laumeier, Inga; Hofacker, Maxi Dana; Raffaelli, Bianca; Burow, Philipp; Dahlem, Markus; Heintz, Simon; Jürgens, Tim P.; Naegel, Steffen; Rimmele, Florian; Scholler, Simon; Kurth, Tobias; Reuter, Uwe; Neeb, Lars

doi:10.3389/fneur.2022.912288

Cited by 3 publications

(1 citation statement)

References 39 publications

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“…Das multizentrische, aus Berlin stammende Projekt SMARTGEM versuchte über die App M-Sense über eine digitale Kopfschmerzdokumentation und Identifikation von persönlichen Triggerfaktoren in Kombination mit einem moderierten Patientenforum, Edukationsmodulen, Angeboten für nicht-medikamentöse Therapien wie Entspannungsverfahren oder verhaltenstherapeutischen Übungen, und einer telemedizinischen Vernetzung von Kopfschmerzambulanzen und den niedergelassenen Bereich einen Therapieeffekt zu bewirken. Die Kontrollgruppe erhielt lediglich ein digitales Kopfschmerztagebuch über eine eingeschränkte Version der M-Sense-App [9]. Die zwischenzeitlich im DiGA-Verzeichnis gelistete App wurde jedoch auf Antrag des Herstellers aus dem DiGA-Verzeichnis zurückgezogen und steht nicht mehr zur Verfügung [10].…”

Section: Kopfschmerzkalender Digital Führenunclassified

Digitalisierung in der Migränetherapie

Lindner,

Holle-Lee,

Scheffler

2024

Fortschr Neurol Psychiatr

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ZusammenfassungDigitalisierung ist ein viel verwendetes Schlagwort in der Medizin und hat auch die Migräne und ihre Therapie erreicht. Digitalisierung soll allerdings kein Selbstzweck sein, sondern die Behandlung von Patienten verbessern und die Arbeit von Behandlern erleichtern. Dieser Artikel beschäftigt sich mit den Bereichen der Migränemedizin, wo dies heute schon so ist bzw. zukünftig so sein kann.

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Section: Kopfschmerzkalender Digital Führenunclassified

Digitalisierung in der Migränetherapie

Lindner,

Holle-Lee,

Scheffler

2024

Fortschr Neurol Psychiatr

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Feasibility and Usability of a Mobile App–Based Interactive Care Plan for Migraine in a Community Neurology Practice: Development and Pilot Implementation Study

Young,

Ridgeway,

Haddad

et al. 2023

JMIR Form Res

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Background Migraine is a common and major cause of disability, poor quality of life, and high health care use. Access to evidence-based migraine care is limited and projected to worsen. Novel mobile health app–based tools may effectively deliver migraine patient education to support self-management, facilitate remote monitoring and treatment, and improve access to care. The risk that such an intervention may increase the care team workload is a potential implementation barrier. Objective This study aims to describe a novel electronic health record–integrated mobile app–based Migraine Interactive Care Plan (MICP) and evaluate its feasibility, usability, and impact on care teams in a community neurology practice. Methods Consecutive enrollees between September 1, 2020, and February 16, 2022, were assessed in a single-arm observational study of usability, defined by 74.3% (127/171) completing ≥1 assigned task. Task response rates, rate and type of care team escalations, and patient-reported outcomes were summarized. Patients were prospectively recruited and randomly assigned to routine care with or without the MICP from September 1, 2020, to September 1, 2021. Feasibility was defined by equal to or fewer downstream face-to-face visits, telephone contacts, and electronic messages in the MICP cohort. The Wilcoxon rank-sum test was used to compare continuous variables, and the chi-square test was used for categorical variables for those with at least 3 months of follow-up. Results A total of 171 patients were enrolled, and of these, 127 (74.3%) patients completed ≥1 MICP-assigned task. Mean escalations per patient per month was 0.9 (SD 0.37; range 0-1.7). Patient-confirmed understanding of the educational materials ranged from 26.6% (45/169) to 56.2% (95/169). Initial mean headache days per week was 4.54 (SD 2.06) days and declined to 2.86 (SD 1.87) days at week 26. The percentage of patients reporting favorable satisfaction increased from a baseline of 35% (20/57) to 83% (15/18; response rate of 42/136, 30.9% to 28/68, 41%) over the first 6 months. A total of 121 patients with MICP were compared with 62 patients in the control group. No differences were observed in the rate of telephone contacts or electronic messages. Fewer face-to-face visits were observed in the MICP cohort (13/121, 10.7%) compared with controls (26/62, 42%; P<.001). Conclusions We describe the successful implementation of an electronic health record–integrated mobile app–based care plan for migraine in a community neurology practice. We observed fewer downstream face-to-face visits without increasing telephone calls, medication refills, or electronic messages. Our findings suggest that the MICP has the potential to improve patient access without increasing care team workload and the need for patient input from diverse populations to improve and sustain patient engagement. Additional studies are needed to assess its impact in primary care.

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Feasibility and Usability of a Mobile App–Based Interactive Care Plan for Migraine in a Community Neurology Practice: Development and Pilot Implementation Study (Preprint)

Young¹,

Ridgeway²,

Haddad³

et al. 2023

Preprint

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BACKGROUND Migraine is a common major cause of disability, poor quality of life, and high health care utilization. Access to evidence-based migraine care is limited and projected to worsen. Novel health care delivery models including mHealth app-based tools may mitigate these challenges. OBJECTIVE We developed an electronic health record (EHR) integrated mobile app-based migraine interactive care plan (MICP) to remotely monitor, deliver education and facilitate care team communication for patients with migraine. This multi-method study describes the MICP and pilot evaluation of its feasibility, usability, and impact on care teams in a community neurology practice. METHODS Consecutive enrollees between 9/1/2020 and 2/16/2022 were assessed in a single arm observational study. Usability was defined by ≥ 75% of patients completing ≥ 1 assigned task. Task response rates, rate and type of care team escalations, and patient reported clinical outcomes were summarized. Feasibility was defined by equal-to or fewer downstream face-to-face visits, telephone contacts, and electronic messages. From 9/1/2020 to 9/1/21 eligible patients were prospectively recruited and randomly assigned to routine care with or without the MICP. Demographic data and occurrence of face-to-face visits, telephone contacts, electronic messages were extracted from the EHR. The Wilcoxon ranked summed test was used to compare continuous variables and the Chi-square test for categorical variables for those with at least 3 months of follow-up. RESULTS A total of 171 patients enrolled and 127 (74.3%) completed ≥ 1 MICP assigned task. Mean escalations per patient per month was 0.9 (SD 0.37; range 0-1.7). Patient confirmed understanding of educational materials ranged from 26.7% to 56.3%. Initial mean headache days per week was 4.54 days (SD 2.06) and trended down to 2.86 days (SD 1.87) at week 26. Baseline mean total MIDAS score was 110 (SD 107; range 3-452) with a response rate of 59% (n=100/170). The percentage of patients reporting favorable satisfaction increased from a baseline of 35% to 59% (response rate of 30-41%) over the first 6 months. A total of 121 with MICP were compared to 62 patients in the control group. No differences were observed in the rate of telephone contacts or electronic messages. Fewer face-to-face visits were observed in the MICP cohort (n=13/121, 10.7%) compared to controls (n=26/62, 42%; P < .001). CONCLUSIONS We describe successful implementation of an EHR integrated mobile app-based interactive care plan for migraine in a community neurology practice. Our findings suggest that the MICP holds potential for improving patient access and reducing healthcare utilization without increasing care team work. Additional studies are needed to assess the impact on utilization and outcomes in other settings such as primary care. Our findings also suggest the need for direct patient input from diverse populations to improve the MICP and sustain patient-engagement.

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Study Design and Protocol of a Randomized Controlled Trial of the Efficacy of a Smartphone-Based Therapy of Migraine (SMARTGEM)

Cited by 3 publications

References 39 publications

Digitalisierung in der Migränetherapie

Digitalisierung in der Migränetherapie

Feasibility and Usability of a Mobile App–Based Interactive Care Plan for Migraine in a Community Neurology Practice: Development and Pilot Implementation Study

Feasibility and Usability of a Mobile App–Based Interactive Care Plan for Migraine in a Community Neurology Practice: Development and Pilot Implementation Study (Preprint)

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