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Does a video clip enhance recruitment into a parenting trial? Learnings from a study within a trial.

ABSTRACT: BACKGROUND:Reaching recruitment targets in randomised controlled trials is a challenge. Media tools are increasingly used to engage participants, yet there is a paucity of research into the use of video to optimise recruitment. We therefore tested whether adding a participant information video clip to a standard participant information sheet improved recruitment into a parenting trial. METHODS:One hundred seven participants were randomised to receive either a participant information sheet (n?=?51) or an informational video clip (n?=?56) as part of an email contact following a screening phase. All participants went on to receive the information sheet as part of the existing consent procedure. RESULTS:The video condition did not increase the odds of recruitment into the trial, such that those in the video condition were significantly less likely to participate in the main trial (OR?=?0.253, CI?=?0.104-0.618, p?=?0.003). CONCLUSION:The introduction of a video clip into the recruitment stages of a parenting trial did not lead to an improvement in recruitment; however, the small sample size precludes definitive inferences. We offer reflections on challenges encountered in implementing the SWAT and suggestions for other researchers seeking to embed recruitment SWATs into similar trials. TRIAL REGISTRATION:Current controlled trials ISRCTN 58327365 . Registered on 19 March 2015. SWAT REGISTRATION:SWAT 106; Effects of a video clip on recruitment into a randomised trial. Registered on 20 December 2016.

SUBMITTER: Mattock HC

PROVIDER: S-EPMC7558733 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Does a video clip enhance recruitment into a parenting trial? Learnings from a study within a trial.

Mattock Holly C HC Ryan Rachael R O'Farrelly Christine C Babalis Daphne D Ramchandani Paul G PG

Trials 20201015 1

<h4>Background</h4>Reaching recruitment targets in randomised controlled trials is a challenge. Media tools are increasingly used to engage participants, yet there is a paucity of research into the use of video to optimise recruitment. We therefore tested whether adding a participant information video clip to a standard participant information sheet improved recruitment into a parenting trial.<h4>Methods</h4>One hundred seven participants were randomised to receive either a participant informati ...[more]

PMID: 33059763

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Project description:BACKGROUND/AIMS:In this study, we compared two research consent techniques: a standardized video plus usual consent and usual consent alone. METHODS:Individuals who completed 24-month outcomes (completers) in the Operations and Pelvic Muscle Training in the Management of Apical Support Loss study were invited to participate in an extended, longitudinal follow-up study (extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss). Potential participants who were (1) able to provide consent and (2) not in long-term care facilities were randomized 1:1 to a standardized video detailing the importance of long-term follow-up studies of pelvic floor disorders followed by the usual institutional consent process versus the usual consent process alone. Randomization, stratified by site, used randomly permuted blocks. The primary outcome was the proportion of participants who enrolled in the extended study and completed data collection events 5?years after surgery. Secondary outcomes included the proportion enrolled in the extended study, completion of follow-up at each study year, completion of data collection points, completion of in-person visits, and completion of quality of life calls. Motivation and barriers to enrollment (study-level and personal-level) and satisfaction with the study consent process were measured by questionnaire prior to recruitment into extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss. Groups were compared using an intention-to-treat principle, using unadjusted Student's t-test (continuous) and chi-square or Fisher's exact (categorical) test. A sample size of 340 (170/group) was estimated to detect a 15% difference in enrollment and study completion between groups with p?<?0.05. RESULTS:Of the 327 Operations and Pelvic Muscle Training in the Management of Apical Support Loss completers, 305 were randomized to the consent process study (153 video vs 152 no video). Groups were similar in demographics, surgical treatment, and outcomes. The overall rate of extended study enrollment was high, without significant differences between groups (video 92.8% vs no video 94.1%, p?=?0.65). There were no significant differences in the primary outcome (video 79.1% vs no video 75.7%, p?=?0.47) or in any secondary outcomes. Being "very satisfied" overall with study information (97.7% vs 88.5%, p?=?0.01); "strong agreement" for feeling informed about the study (81.3% vs 70.8%, p?=?0.06), understanding the study purpose (83.6% vs 71.0%, p?=?0.02), nature and extent (82.8% vs 70.2%, p?=?0.02), and potential societal benefits (82.8% vs 67.9%, p?=?0.01); and research coordinator/study nurse relationship being "very important" (72.7% vs 63.4%, p?=?0.03) were better in the video compared to the no video consent group. CONCLUSION:The extended study had high enrollment; most participants completed most study tasks during the 3-year observational extension, regardless of the use of video to augment research consent. The video was associated with a higher proportion of participants reporting improved study understanding and relationship with study personnel.

Project description:BackgroundRecruitment into clinical trials is challenging and there is a lack of evidence on effective recruitment strategies. Personalisation of invitation letters is a potentially pragmatic and feasible way of increasing recruitment rates at a low-cost. However, there is a lack of evidence concerning the effect of personalising of study invitation letters on recruitment rates.MethodsWe undertook a Study Within A Trial (SWAT) to investigate the effect of personalised versus non-personalised study invitation letters on recruitment rates into the host feasibility trial ENGAGE, a feasibility study of an internet-administered, guided, Low Intensity Cognitive-Behavioural Therapy based self-help intervention for parents of children previously treated for cancer. An intervention group (n = 254) received a personalised study invitation letter and the control group (n = 255) received a non-personalised study invitation letter. The primary outcome was the proportion of participants in the intervention group and the control group enrolled into the ENGAGE host feasibility trial. Secondary outcomes relating to the recruitment and screening process, and retention were examined. Differences in proportions between groups for the primary and secondary outcomes were estimated using logistic regression.ResultsOf the 509 potential participants, 56 (11.0%) were enrolled into the ENGAGE host feasibility trial: personalised: 30/254 (11.8%) and non-personalised: 26/255 (10.2%). No statistically significant effect on personalisation of enrolment was found (OR 1.18, 95% CI 0.68-2.06). No statistically significant differences were found for any secondary outcome.ConclusionsPersonalisation of study invitations had no effect on recruitment. However, given the small study sample size in the present SWAT, and lack of similar embedded recruitment RCTs to enable a meta-analysis, additional SWATs to examine the personalisation of study invitation letters are warranted.Trial registrationISRCTN57233429 ; ISRCTN18404129 ; SWAT 112, Northern Ireland Hub for Trials Methodology Research SWAT repository (2018 OCT 1 1231) ( https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/FileStore/Filetoupload,939618,en.pdf ).

Project description:BACKGROUND:This study aimed to investigate the effect of integrating a video intervention "Movie Models" within the Feel4Diabetes-study on specific parenting practices and related parental self-efficacy regarding children's physical activity, screen-time and eating behaviour in vulnerable families (i.e. families living in low socioeconomic municipalities and at risk for developing type 2 diabetes). Additionally, there was examination of how the intervention was perceived by the parents. METHODS:Within randomly selected low socioeconomic municipalities in Belgium, families were recruited through primary schools. Families at risk for developing type 2 diabetes were identified using the FINDRISC questionnaire (n = 457). Afterwards, the municipalities were randomly assigned to the intervention or control condition. At risk families assigned to the intervention group were invited to participate in six Feel4Diabetes counselling sessions in which families were encouraged to adopt a healthier lifestyle. The "Movie Models" videos were integrated within two sessions by using a face-to-face group discussion approach. Parenting-related factors were assessed before and after the integration of the videos, using a questionnaire. After integrating the videos, some extra evaluation questions were assessed. In total, 126 families were included in a per protocol evaluation and Repeated Measures ANOVAs were conducted to evaluate the potential intervention effects. RESULTS:Some favourable intervention effects were found on parenting practices and related parental self-efficacy regarding children's eating behaviours, however almost no effects were found on parenting-related factors regarding children's physical activity and screen-time. In total, 60.0% of the participants indicated that they applied tips regarding parenting practices and 52.0% indicated that discussions with other participants regarding the videos were useful for them. CONCLUSION:The integration of "Movie Models" within the Feel4Diabetes-study was effective in improving some parenting-related factors regarding children's health behaviours, however most parenting-related factors could not be improved. The implementation of "Movie Models" as a face-to-face group discussion approach was relatively well received and may be a promising way to improve parenting-related factors in vulnerable families. TRIAL REGISTRATION:ClinicalTrials.gov NCT02278809.

Project description:BackgroundThe Structured E-Parenting Support (STEPS) app provides support for parents of children with elevated hyperactivity, impulsivity, inattention, and conduct problems who are awaiting clinical assessment. STEPS will be evaluated in a randomized controlled trial (RCT) within the Online Parent Training for the Initial Management of ADHD Referrals (OPTIMA) research program in the United Kingdom. Phase 1 of the OPTIMA tested the feasibility of participants' recruitment and the app's usability.ObjectiveThis study aimed to adapt a digital routine clinical monitoring system, myHealthE, for research purposes to facilitate waitlist recruitment; test using remote methods to screen and identify participants quickly and systematically; pilot the acceptability of the recruitment and assessment protocol; and explore the usability of STEPS.MethodsmyHealthE was adapted to screen patients' data. Parents' and clinicians' feedback on myHealthE was collected, and information governance reviews were conducted in clinical services planning to host the RCT. Potential participants for the observational feasibility study were identified from new referrals using myHealthE and non-myHealthE methods. Descriptive statistics were used to summarize the demographic and outcome variables. We estimated whether the recruitment rate would meet the planned RCT sample size requirement (n=352). In addition to the feasibility study participants, another group of parents was recruited to assess the STEPS usability. They completed the adapted System Usability Scale and responded to open-ended questions about the app, which were coded using the Enlight quality construct template.ResultsOverall, 124 potential participants were identified as eligible: 121 (97.6%) via myHealthE and 3 (2.4%) via non-myHealthE methods. In total, 107 parents were contacted, and 48 (44.9%) consented and were asked if, hypothetically, they would be willing to participate in the OPTIMA RCT. Of the 28 feasibility study participants who provided demographic data, 21 (75%) identified as White. Their children had an average age of 8.4 (SD 1.7) years and 65% (31/48) were male. During the primary recruitment period (June to July 2021) when 45 participants had consented, 38 (84%) participants agreed hypothetically to take part in the RCT (rate of 19/mo, 95% CI 13.5-26.1), meeting the stop-go criterion of 18 participants per month to proceed with the RCT. All parents were satisfied or very satisfied with the study procedures. Parents (n=12) recruited to assess STEPS' usability described it as easy to navigate and use and as having an attractive combination of colors and visual design. They described the content as useful, pitched at the right level, and sensitively presented. Suggested improvements included adding captions to videos or making the recorded reflections editable.ConclusionsRemote recruitment and study procedures for testing a parenting intervention app are feasible and acceptable for parents. The parents felt that STEPS was a useful and easy-to-use digital parenting support tool.International registered report identifier (irrid)RR2-10.1186/s40814-021-00959-0.

Project description:BACKGROUND:Many randomised controlled trials (RCTs) fail to meet their recruitment goals in time. Trialists are advised to include study recruitment strategies within their trials. EFFECTS is a Swedish, academic-led RCT of fluoxetine for stroke recovery. The trial's primary objective is to investigate whether 20 mg fluoxetine daily compared with placebo for 6 months after an acute stroke improves the patient's functional outcome. The first patient was included on 20 October 2014 and, as of 31 August 2017, EFFECTS has included 810 of planned 1500 individuals. EFFECTS currently has 32 active centres. The primary objective of the ERUTECC (Enhancing Recruitment Using Teleconference and Commitment Contract) study is to investigate whether a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% at 60 days post intervention, compared with 60 days pre-intervention, in an ongoing RCT. METHODS:ERUTECC is a randomised, stepped-wedge cluster trial embedded in EFFECTS. The plan is to start ERUTECC with a running-in period of September 2017. The first intervention is due in October 2017, and the study will continue for 12 months. We are planning to intervene at all active centres in EFFECTS, except the five top recruiting centres (n = 27). The rationale for not intervening at the top recruiting centres is that we believe they have reached their full potential and the intervention would be too weak for them. The hypothesis of this study is that a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% 60 days post intervention, compared to 60 days pre-intervention, in an ongoing RCT. DISCUSSION:EFFECTS is a large, pragmatic RCT of stroke in Sweden. Results from the embedded ERUTECC study could probably be generalised to high-income Western countries, and is relevant to trial management and could improve trial management in the future. It might also be useful in clinical settings outside the field of stroke. TRIAL REGISTRATIONS:The ERUTECC study was registered in the Northern Ireland Hub for Trials Methodology Research Studies Within a Trial repository ( SWAT58 ) on 30 April 2017. ClinicalTrials.gov, ID: NCT02683213 . Retrospectively registered on 2 February 2016.

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Does a video clip enhance recruitment into a parenting trial? Learnings from a study within a trial.

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Does a video clip enhance recruitment into a parenting trial? Learnings from a study within a trial.

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