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Randomized Controlled Trial
. 2019 Jan;36(1):52-61.
doi: 10.1111/dme.13840. Epub 2018 Nov 7.

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

A S Adams  1 , J A Schmittdiel  1 , A Altschuler  1 , E A Bayliss  2   3 , R Neugebauer  1 , L Ma  1 , W Dyer  1 , J Clark  1 , B Cook  1 , D Willyoung  1 , M Jaffe  4 , J D Young  5 , E Kim  5 , J M Boggs  2 , L A Prosser  6 , E Wittenberg  7 , B Callaghan  8 , M Shainline  2 , R M Hippler  1 , R W Grant  1
Affiliations
Randomized Controlled Trial

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

A S Adams et al. Diabet Med. 2019 Jan.

Abstract

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 to July 2016) within a large healthcare system. We randomized 1834 primary care physicians and prospectively recruited from their lists 1270 individuals with neuropathy who were newly prescribed medications for their symptoms. Intervention participants received automated telephone-based symptom and side effect monitoring with physician feedback over 6 months. The control group received usual care plus three 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 communication between individuals with neuropathy and their primary care provider over 12 months. Interviewers collecting outcome data were blinded to intervention assignment.

Results: Some 1252 participants completed the baseline measures [mean age (sd): 67 (11.7), 53% female, 57% white, 8% Asian, 13% black, 20% Hispanic]. In total, 1179 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 (95% CI -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 were not effective at improving quality of life or symptoms for people with symptomatic diabetic peripheral neuropathy.

Trial registration: ClinicalTrials.gov (NCT02056431).

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Conflict of interest statement

Conflicts of Interest Disclosures

The authors report no conflicts of interest and that the results of this paper have not been previously published. A brief abstract of the study findings is available on the PCORI webpage at pcori.org/Adams071.

Figures

Figure 1:
Figure 1:. Clinical Trial Flowchart
Reasons for ineligibility (patients could have more than one): patient did not recall being prescribed a new medication (193), had no symptoms (152), denied having diabetes (2), had only a rotary phone and unable to receive IVR calls (1), was on the no contact registry (1), was no longer a KP member (16), was prescribed a study drug for a condition other than DPN (290), was unable to communicate in English or Spanish (1), or was unreachable or unavailable during the length of the study (3).
Figure 2:
Figure 2:
Description of Study Arms
See this image and copyright information in PMC

References

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