Trial reportTrials2016
Recruiting to Clinical Trials on the Telephone - a randomized controlled trial.
Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02570061 (Recruiting to Clinical Trials on the Telephone), which is not on this map. Cited by 8 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Recruiting to Clinical Trials on the Telephone
Who cites it
8 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Strategies to improve recruitment to randomised trials.The Cochrane database of systematic reviews · 2026Pooled it
- Pooled it
- Strategies to improve recruitment to randomised trials.The Cochrane database of systematic reviews · 2018Pooled it
- Patient engagement and shared decision-making in trial recruitment intervention studies: a systematic review.Research involvement and engagement · 2025Review
- Describing the content of trial recruitment interventions using the TIDieR reporting checklist: a systematic methodology review.BMC medical research methodology · 2024Article
- AYA-UNITE: Lessons Learned on Intervention Development Promoting Social and Physical Health of Adolescent/Young Adult Cancer Survivors.Journal of adolescent and young adult oncology · 2023Article
- Developing an intervention to optimise the outcome of cardiac surgery in people with diabetes: the OCTOPuS pilot study.Pilot and feasibility studies · 2021Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInformed consent is an essential element of clinical research. Obtaining consent, however, may be challenging. The use of the telephone for giving information and obtaining consent may be practical but little formal research has been done.
methodsWe examined the use of the telephone for the purpose of informing expectant mothers about The Danish Calmette Study; a randomized clinical trial assessing neonatal Bacille Calmette-Guérin vaccination. Expectant mothers received an invitation letter with a Participant Information Sheet about The Danish Calmette Study, the present trial, and a Consent Form. Two to 4 weeks later we contacted the mothers to discuss potential participation in the present trial. At this initial telephone contact, and after consent from the mothers, we randomized expectant mothers to receive the verbal information about The Danish Calmette Study by telephone, or at a face-to-face consultation. The primary outcome was a communication score, consisting of comprehension of information about The Danish Calmette Study and satisfaction with the information process. The outcome was measured using a questionnaire 2 days after the information was provided, and 2.5 months after the birth of the child.
resultsThe communication score obtained 2 days after information was given was significantly reduced in the telephone group, effect size -0.74 (95% confidence interval (CI), -1.11 to -0.36). The effect sizes of the subscores were -0.87 (95% CI, -1.25 to -0.49) for satisfaction and -0.22 (95% CI, -0.58 to 0.14) for comprehension. The effect sizes were slightly reduced when assessed 2.5 months after the birth.
conclusionThe communication score was reduced in the telephone group. This was due to a reduction in satisfaction, while no difference in the comprehension could be found in comparison to the control group. This may be ethically acceptable as both groups had high satisfaction scores.
trial registrationClinicalTrials.gov, registered on 5 October 2015 with trial registration number NCT02570061 .
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.