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JAMA Intern Med. 2018 Oct 1;178(10):1368-1377. doi: 10.1001/jamainternmed.2018.3981.

Effect of Mobile Device-Supported Single-Patient Multi-crossover Trials on Treatment of Chronic Musculoskeletal Pain: A Randomized Clinical Trial.

Author information

1
Department of Internal Medicine, University of California, Davis, Sacramento.
2
Center for Health Care Policy and Research, University of California, Davis, Sacramento.
3
Department of Biostatistics and Center for Evidence Synthesis in Health, Brown University School of Public Health, Providence, Rhode Island.
4
Veterans Affairs Northern California Health Care System, Sacramento Medical Center, Mather.
5
Department of Psychiatry, University of California, San Diego, San Diego.
6
Betty Irene Moore School of Nursing, University of California, Davis, Sacramento.
7
Division of General Internal Medicine & Health Services Research, Department of Medicine, University of California, Los Angeles, Los Angeles.
8
Department of Psychiatry, Columbia University, New York, New York.
9
Department of Clinical Informatics, University of California, Davis Medical Center, Sacramento.
10
Department of Family and Community Medicine, University of California, Davis, Sacramento.
11
Division of Environmental Health Sciences, University of Minnesota School of Public Health, Minneapolis.
12
Open mHealth, New York, New York.
13
Department of General Internal Medicine, University of California, San Francisco, San Francisco.

Abstract

Importance:

Individually designed single-patient multi-crossover (n-of-1) trials can facilitate tailoring of treatments directed at various conditions, including chronic musculoskeletal pain (CMSP) but are potentially burdensome, which may limit uptake in research and practice.

Objectives:

To determine whether patients randomized to participate in an n-of-1 trial supported by a mobile health (mHealth) app would experience less pain and improved global health, adherence, satisfaction, and shared decision making compared with patients assigned to usual care.

Design, Setting, and Participants:

This randomized clinical trial compared participation in an individualized, mHealth-supported n-of-1 trial vs usual care. The participating 215 patients had CMSP for at least 6 weeks, had a smartphone or tablet with a data plan, were enrolled in northern California from July 2014 through July 2016, and were followed for up to 1 year by 48 clinicians in academic, community, Veterans Affairs, and military settings.

Interventions:

Intervention patients met with their clinicians and used a desktop interface to select treatments and trial parameters for an n-of-1 trial comparing 2 pain-management regimens. The mHealth app provided reminders to take designated treatments on assigned days and to upload responses to daily questions on pain and treatment-associated adverse effects. Control patients received care as usual.

Main Outcomes and Measures:

The primary outcome was change in the PROMIS (Patient-Reported Outcomes Measurement Information System) pain-related interference 8-item short-form scale (full scale range, 41-78) from baseline to 6 months. Secondary outcomes included patient-reported pain intensity, overall health, analgesic adherence, trust in clinician, satisfaction with care, medication-related shared decision making, and, for the n-of-1 group only, participant engagement and experience.

Results:

Among 215 patients (108 randomized to the n-of-1 intervention and 107 to control), 102 (47%) were women, and the mean (SD) age was 55.5 (11.1) years. At the 6-month follow-up, pain interference was reduced in both groups, though there was no difference between the intervention and control groups (-1.36 points; 95% CI, -2.91 to 0.19 points; P = .09). There were no advantages in secondary outcomes for intervention patients vs control patients except for higher medication-related shared decision making at 6 months (between-group difference, 11.9 points; 95% CI, 2.6-21.2 points; P = .01). Among patients assigned to the n-of-1 group, 88% (n = 86) affirmed that the mHealth app could help people like them manage their pain.

Conclusions and Relevance:

In this population of patients with CMSP, mHealth-supported n-of-1 trials were feasible and associated with a satisfactory user experience, but n-of-1 trial participation did not significantly improve pain interference at 6 months vs usual care.

Trial Registration:

ClinicalTrials.gov identifier: NCT02116621.

PMID:
30193253
PMCID:
PMC6233756
[Available on 2019-09-04]
DOI:
10.1001/jamainternmed.2018.3981
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