Abstract

BackgroundAttrition is problematic in trials, and may be exacerbated in longer studies, telehealth trials and participants with depression – three features of The Healthlines Study. Advance notification, including a photograph and using action-oriented email subject lines might increase response rates, but require further investigation. We examined the effectiveness of these interventions in three embedded Healthlines studies.MethodsBased in different trial sites, participants with depression were alternately allocated to be pre-called or not ahead of the 8-month follow-up questionnaire (Study 1), randomized to receive a research team photograph or not with their 12-month questionnaire (Study 2), and randomized to receive an action-oriented (‘ACTION REQUIRED’) or standard (‘Questionnaire reminder’) 12-month email reminder (Study 3). Participants could complete online or postal questionnaires, and received up to five questionnaire reminders. The primary outcome was completion of the Patient Health Questionnaire (PHQ-9). Secondary outcome measures were the number of reminders and time to questionnaire completion.ResultsOf a total of 609 Healthlines depression participants, 190, 251 and 231 participants were included in Studies 1–3 (intervention: 95, 126 and 115), respectively. Outcome completion was ≥90 % across studies, with no differences between trial arms (Study 1: OR 0.38, 95 % CI 0.07–2.10; Study 2: OR 0.84, 95 % CI 0.26–2.66; Study 3: OR 0.53 95 % CI 0.19–1.49). Pre-called participants were less likely to require a reminder (48.4 % vs 62.1 %, OR 0.41, 95 % CI 0.21–0.78), required fewer reminders (adjusted difference in means −0.67, 95 % CI −1.13 to −0.20), and completed follow-up quicker (median 8 vs 15 days, HR 1.35, 95 % CI 1.00–1.82) than control subjects. There were no significant between-group differences in Studies 2 or 3.ConclusionsEventual response rates in this trial were high, with no further improvement from these interventions. While the photograph and email interventions were ineffective, pre-calling participants reduced time to completion. This strategy might be helpful when the timing of study completion is important. Researchers perceived a substantial benefit from the reduction in reminders with pre-calling, despite no overall decrease in net effort after accounting for pre-notification.Trial registrationCurrent Clinical Trials ISRCTN14172341Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1234-3) contains supplementary material, which is available to authorized users.

Highlights

  • Attrition is problematic in trials, and may be exacerbated in longer studies, telehealth trials and participants with depression – three features of The Healthlines Study

  • The trials were approved by the National Research Ethics Service Committee South West – Frenchay (Reference 12/ SW/0009), participants gave written informed consent, and the depression trial is registered with Current Controlled Trials (ISRCTN14172341; registered, 26 June 2012)

  • Study 1: pre-call study To mitigate response rate concerns, the pre-call intervention was devised and introduced partway through the 8-month follow-up. After excluding those participants who had already had their 8-month follow-up by this point (n = 114) or had withdrawn from the main host trial (n = 14), 190 of the 318 Healthlines Study depression participants from the Bristol study centre were alternately allocated to the pre-call study between September 2013 and March 2014

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Summary

Introduction

Attrition is problematic in trials, and may be exacerbated in longer studies, telehealth trials and participants with depression – three features of The Healthlines Study. 3–4 months into the start of the 8-month follow-up in the depression trial, it was apparent that the response rate (approximately 60–70 %) was falling below the 4-month rate for the equivalent time period (approximately 85 %), but below the trial protocol target of 80 %. This downward trend was not evident in the cardiovascular disease trial, and so three simple interventions were introduced to try to improve response rates amongst the depression group alone

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