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

Details

• Alternative Title:
  Diabet Med
• Personal Author:
  Adams, Alyce S. ; Schmittdiel, Julie A. ; Altschuler, Andrea ; Bayliss, Elizabeth A. ; Neugebauer, Romain ; Ma, Lin ; Dyer, Wendy ; Clark, Joel ; Cook, Bonieta ; Willyoung, David ; Jaffe, Marc ; Young, Joseph D. ; Kim, Eileen ; Boggs, Jennifer M. ; Prosser, Lisa ; Wittenberg, Eve ; Callaghan, Brian ; Shainline, Michael ; Hippler, Rosa M. ; Grant, Richard W.
• 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)
  
  
• Subjects:
  Aged Cluster Analysis Diabetic Neuropathies Female Humans Male Middle Aged Monitoring, Physiologic Outcome Assessment, Health Care Practice Patterns, Physicians' Primary Health Care Quality Of Life

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• Keywords:
  Automated Monitoring Diabetes Peripheral Neuropathy
• Source:
  Diabet Med. 36(1):52-61
• Pubmed ID:
  30343489
• Pubmed Central ID:
  PMC7236318
• Document Type:
  Journal Article
• Funding:
  K23 NS079417/NS/NINDS NIH HHSUnited States/ ; R01 HL117939/HL/NHLBI NIH HHSUnited States/ ; U58 DP002641/DP/NCCDPHP CDC HHSUnited States/ ; R01 DK099108/DK/NIDDK NIH HHSUnited States/ ; R01DK099108/National Institute for Diabetes, Digestive and Kidney DiseasesInternational/ ; P30 DK092924/DK/NIDDK NIH HHSUnited States/ ; K24DK109144/National Institute for Diabetes, Digestive and Kidney DiseasesInternational/
• Volume:
  36
• Issue:
  1
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:5024cef984d3d21300e53396163e0a616184ecf56629330b4332f270d441c6b4
• Download URL:
  https://stacks.cdc.gov/view/cdc/88162/cdc_88162_DS1.pdf
• File Type:
  [PDF - 356.43 KB ]