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Automated Symptom and Treatment Side Effect Monitoring for Improved Quality of Life among Adults with Diabetic Peripheral Neuropathy in Primary Care: A Pragmatic, Cluster, Randomized, Controlled Trial
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1 2019
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Source: Diabet Med. 36(1):52-61
Details:
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Alternative Title:Diabet Med
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Personal Author:
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Description:Aims:
To evaluate the effectiveness of automated symptom and side effect monitoring on quality of life among individuals with symptomatic diabetic peripheral neuropathy.
Methods:
We conducted a pragmatic, cluster randomized controlled trial (July 2014 through July 2016) within a large health care system. We randomized 1,834 primary care physicians and prospectively recruited 1,270 of their patients newly prescribed medications to treat neuropathy symptoms. Intervention participants received automated telephone-based symptom and side effect monitoring with physician feedback over six months. The control group received usual care plus 3 non-interactive diabetes educational calls. Our primary outcomes were quality of life (EQ-5D) and select symptoms (e.g., pain) measured 4-8 weeks after starting medication and again 8 months after baseline. Process outcomes included receiving a clinically effective dose and patient-provider communication over 12 months. Interviewers collecting outcome data were blinded to intervention assignment.
Results:
1,252 participants completed baseline [mean age [st. dev.]: 67 [11.7], 53% female, 57% white, 8% Asian, 13% black, 20% Hispanic]. 1,179 participants (93%) completed follow up (619 control, 560 intervention). Quality of life scores [intervention: 0.658[0.094]; control: 0.653[0.092]] and symptom severity were similar at baseline. The intervention had no effect on primary [EQ-5D: −0.002 (−0.01, 0.01), p=0.623; pain: 0.295 (−0.75, 1.34), p=0.579; sleep disruption: 0.342 (−0.18, 0.86), p=0.196; lower extremity functioning: −0.079 (−1.27, 1.11), p=0.896; depression: −0.462 (−1.24, 0.32); p=0.247] or process outcomes.
Conclusions:
Automated telephone monitoring and feedback alone was not effective at improving patient quality of life or symptoms for individuals with symptomatic diabetic peripheral neuropathy.
Trial Registration:
ClinicalTrials.gov (NCT02056431)
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Pubmed ID:30343489
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Pubmed Central ID:PMC7236318
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Volume:36
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Issue:1
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