NCT02056431

Brief Summary

Painful diabetic peripheral neuropathy (DPN) affects more than 5.5 million people with diabetes. People with painful DPN have trouble sleeping, participating in social events, and conducting daily activities such as going to the store. Several prescription medications are available for the treatment of DPN symptoms, but none work perfectly and all have side effects that may be difficult for some patients. When patients report their symptoms and side effects to their doctor, they provide the doctor with important information to help them make adjustments to treatment that will help with symptoms and that the patient can tolerate in terms of side effects. In some cases, doctors may encourage patients to make these changes on their own at home based on their experience with therapy. However, patients may have a long time between visits to their doctor and may have trouble describing their symptoms to their doctor during a brief 10 to 15 minute visit. This clinical trial explores the possibility of computerized telephone calls to patients (Interactive Voice Response, IVR, technology) to gather information about treatment experiences that can then be reported to the doctor or used to guide patients to make changes in how they take the medication. It addresses the following question: Can routinely asking patients about their experiences with medications and using that information to encourage clinically appropriate titration improve patient quality of life? The investigators hypothesize that systematic collection and feedback of information about DPN treatment preferences and experience from newly treated patients to their primary care physician will facilitate treatment changes that improve patient outcomes

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 12, 2018

Completed
Last Updated

June 28, 2018

Status Verified

May 1, 2018

Enrollment Period

1.8 years

First QC Date

January 31, 2014

Results QC Date

October 31, 2016

Last Update Submit

May 16, 2018

Conditions

Diabetic Peripheral Neuropathy

Keywords

DiabetesNeuropathyPatient-Reported Outcomes

Outcome Measures

Primary Outcomes (1)

  • Change in Patient Quality of Life at Baseline and 8 Months

    The primary outcome measure is change in quality of life from baseline at eight months following study entry. We calculated the EuroQOL (EQ-5D) from the Global Health Scale, a 10-item Patient-Reported Outcomes Measurement Information System measure developed and validated in patients with neuropathy as part of the Quality of Life in Neurological Disorders Measures. The range for EQ-5D is 0-1, with "0" being the worst and "1" being the best.

    Baseline and 8 months

Secondary Outcomes (1)

  • Number of Participants With Minimally Effective Dose in 12 Months

    12 months

Study Arms (2)

IVR Intervention Group

EXPERIMENTAL

Participants will receive 3 interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) to collect information on medication use, side effects, rating of side effects, and pain symptoms to be fed back to their physicians.

Behavioral: IVR Intervention Group

IVR Control Group

NO INTERVENTION

Participants will receive 3 non-interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) containing general messages regarding diabetic education.

Interventions

IVR Intervention GroupBEHAVIORAL

Participants will receive 3 interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) to collect information on medication use, side effects, rating of side effects, and pain symptoms to be fed back to their physicians.

IVR Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients newly prescribed medication to treat diabetic peripheral neuropathy symptoms.

You may not qualify if:

  • Patients with any evidence of use of diabetic peripheral neuropathy study medications.
  • Patients with evidence of gestational diabetes (ICD-9: 648.8) due to variation in treatment and monitoring for women who are pregnant.
  • Patients who simultaneously received a new diagnosis for depression or seizure conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Research Kaiser Permanente

Oakland, California, 94612, United States

Location

Related Publications (2)

  • Adams AS, Bayliss EA, Schmittdiel JA, Altschuler A, Dyer W, Neugebauer R, Jaffe M, Young JD, Kim E, Grant RW; Diabetes Telephone Study Team. The Diabetes Telephone Study: Design and challenges of a pragmatic cluster randomized trial to improve diabetic peripheral neuropathy treatment. Clin Trials. 2016 Jun;13(3):286-93. doi: 10.1177/1740774516631530. Epub 2016 Mar 31.

    PMID: 27034455RESULT

  • Adams AS, Schmittdiel JA, Altschuler A, Bayliss EA, Neugebauer R, Ma L, Dyer W, Clark J, Cook B, Willyoung D, Jaffe M, Young JD, Kim E, Boggs JM, Prosser LA, Wittenberg E, Callaghan B, Shainline M, Hippler RM, Grant RW. 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. Diabet Med. 2019 Jan;36(1):52-61. doi: 10.1111/dme.13840. Epub 2018 Nov 7.

    PMID: 30343489DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Dr. Alyce S. Adams
Organization
Kaiser Permanente Division of Research
Alyce.S.Adams@kp.org
510-891-5921

Study Officials

  • Alyce S. Adams, PhD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2014

First Posted

February 6, 2014

Study Start

October 1, 2014

Primary Completion

July 1, 2016

Study Completion

September 1, 2016

Last Updated

June 28, 2018

Results First Posted

February 12, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)