NCT02543723

Telehealth-based Strategies to Increase Oral Chemotherapeutic Agent Medication Adherence

Completed NA Results posted Last updated 22 July 2021

What this trial tests

NA trial testing Nurse Coach Intervention in Medication Adherence in 128 participants. Completed in 31 December 2020.

Timeline

15 November 2015

Primary endpoint
30 March 2020

31 December 2020

Quick facts

Lead sponsor	East Carolina University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	128
Start date	15 November 2015
Primary completion	30 March 2020
Estimated completion	31 December 2020
Sites	1 location across United States

Drugs / interventions tested

• Nurse Coach Intervention

Conditions studied

• Medication Adherence — all drugs for Medication Adherence →

Sponsor

East Carolina University

Who can join

18 and older, any sex, with Medication Adherence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Medication Adherence at Baseline and 6-month Follow-up Period Primary · Baseline and at 6 months

The participant's cancer medication adherence was taken at baseline and within a 6-month follow-up period. We measured the participant's self-efficacy with medication adherence increase with their OCAs using the SEAMS scale. SEAMS Scale: 21 items scale, ranges from 21-63, higher scores indicate higher level of self-efficacy for medication adherence.

Group	Value	95% CI
Nurse Coach Intervention	59.4	± 5.18
Control	55.95	± 9.34

Health Literacy at Baseline and 6-month Follow-up Period Secondary · Baseline and at 6 months

We measured the participant's cancer health literacy at baseline and at 6 months via the CHLT-30. The CHLT-30 measures cancer health literacy along a continuum with 0-30 representing the number of correct answers provided to the items. Continuous scores provided by the CHLT-30 do not allow to determine who has limited health literacy or put people in a category, with higher scores indicating a higher degree of cancer health literacy.

Group	Value	95% CI
Nurse Coach Intervention	22.95	± 4.62
Control	23.32	± 8.36

Sponsor's own description

Oral chemotherapeutic agents (OCAs) are increasingly being used as an alternative to traditional intravenous chemotherapy, and factors promoting this trend include increased survival times requiring long-term therapy, acceptability among patients, convenience, and cost savings due to reduced hospital time. Although OCAs are commonly preferred by patients, adherence to these medications vary. Suboptimal medication adherence leads to loss of treatment efficacy, increased toxicity, and increased health care costs. Thus, it is critical to develop and test interventions that effectively improve adherence to OCAs. Although the medication adherence literature has been criticized for methodological issues, some components of interventions have had promising results on adherence such as electronic monitored adherence feedback, cognitive-education, nurse-based interventions, and technology-based or telehealth strategies. The investigators propose to unify components of these effective approaches in a novel way to assess the efficacy and feasibility of two telehealth-based strategies (electronic medication-event monitoring with feedback and tailored nurse coaching which includes cognitive-education) in an effort increase OCA adherence among cancer patients who are at high-risk for non-adherence in rural eastern North Carolina.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Telemedicine and the assessment of clinician time: a scoping review.
   Kidholm K, Jensen LK, Johansson M, Montori VM. · · 2023 · cited 16× · PMID 38099431 · DOI 10.1017/s0266462323002830