Dataset Information

The effect of mobile personalised texting versus non-personalised texting on the caries risk of underprivileged adults: a randomised control trial.

ABSTRACT:

Background

In the Republic of Ireland (RoI), fluoridation has been effective and efficient for caries prevention at population level, regardless of income status; however, at individual level it still has limitations. This study aimed to compare personalised versus non-personalised text messaging on 'chance of avoiding new cavities' with the Cariogram, a computer-based caries risk assessment (CRA) model, in an economically disadvantaged adult population in the RoI.

Methods

The intervention was via a CRA summary letter plus 24 weekly personalised mobile-phone short text messages (text messages) based on the individual's CRA, compared with a non-personalised approach via a non-personalised letter and a predetermined, fixed set of 24 weekly text messages. The study was designed as a two-arm parallel-group, single-blinded (assessor), randomised controlled study in County Cork, RoI. The primary outcome was a comparison of 'chance of avoiding new cavities' calculated by the Cariogram with clinical examination, interview, CRT® (Ivoclar Vivadent, Liechtenstein) and three-day food diary between the two groups at follow-up. We combined stratified randomisation with blocked randomisation for 171 participants who completed baseline. Of them, 111 completed follow-up and were analysed (56 and 55 from the personalised and non-personalised groups, respectively). Due to protocol violations, both intent-to-treat (ITT) and per-protocol analyses were conducted.

Results

The ITT analysis did not show a personalised intervention effect on 'chance of avoiding new cavities'. Of the secondary outcome measures, only the stimulated saliva flow factor showed a personalised intervention effect, p?=?0.036, OR?=?0.3 (95% CI?=?0.1, 0.9). The per-protocol analysis with 21 personalised and 33 non-personalised participants within two-message deviations showed no significant effect on 'chance of avoiding new cavities'.

Conclusions

The null hypothesis in regard to the primary outcome for both ITT and per-protocol analyses was not rejected; however, as the minimal clinically important difference was included in the 95% CI for the per-protocol analysis, replication studies will be worth conducting to explore the potential of mobile devices for individual caries risk reduction.

Trial registration

University Hospital Medical Information Network Clinical Trials Registry ( UMIN000027253 ) on 10 May 2017. The study was retrospectively registered.

SUBMITTER: Nishi M

PROVIDER: S-EPMC6417196 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The effect of mobile personalised texting versus non-personalised texting on the caries risk of underprivileged adults: a randomised control trial.

Nishi Makiko M Kelleher Virginia V Cronin Michael M Allen Finbarr F

BMC oral health 20190312 1

<h4>Background</h4>In the Republic of Ireland (RoI), fluoridation has been effective and efficient for caries prevention at population level, regardless of income status; however, at individual level it still has limitations. This study aimed to compare personalised versus non-personalised text messaging on 'chance of avoiding new cavities' with the Cariogram, a computer-based caries risk assessment (CRA) model, in an economically disadvantaged adult population in the RoI.<h4>Methods</h4>The int ...[more]

PMID: 30866895

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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:INTRODUCTION:The challenges of global ageing and the growing burden of chronic diseases require innovative interventions acting on health determinants like social participation. Many older adults do not have equitable opportunities to achieve full social participation, and interventions might underempower their personal and environmental resources and only reach a minority. To optimise current practices, the Accompagnement-citoyen Personnalisé d'Intégration Communautaire (APIC), an intervention demonstrated as being feasible and having positive impacts, needs further evaluation. METHODS AND ANALYSIS:A pragmatic multicentre, prospective, two-armed, randomised controlled trial will evaluate: (1) the short-term and long-term effects of the APIC on older adults' health, social participation, life satisfaction and healthcare services utilisation and (2) its cost-effectiveness. A total of 376 participants restricted in at least one instrumental activity of daily living and living in three large cities in the province of Quebec, Canada, will be randomly assigned to the experimental or control group using a centralised computer-generated random number sequence procedure. The experimental group will receive weekly 3-hour personalised stimulation sessions given by a trained volunteer over the first 12 months. Sessions will encourage empowerment, gradual mobilisation of personal and environmental resources and community integration. The control group will receive the publicly funded universal healthcare services available to all Quebecers. Over 2 years (baseline and 12, 18 and 24 months later), self-administered questionnaires will assess physical and mental health (primary outcome; version 2 of the 36-item Short-Form Health Survey, converted to SF-6D utility scores for quality-adjusted life years), social participation (Social Participation Scale) and life satisfaction (Life Satisfaction Index-Z). Healthcare services utilisation will be recorded and costs of each intervention calculated. ETHICS AND DISSEMINATION:The Research Ethics Committee of the CIUSSS Estrie - CHUS has approved the study (MP-31-2018-2424). An informed consent form will be read and signed by all study participants. Findings will be published and presented at conferences. TRIAL REGISTRATION NUMBER:NCT03161860; Pre-results.

Project description:PurposeTo assess the impact of personalised physician learning (PPL) interventions using simulated learning cases on control of hypertension and dyslipidaemia in primary care settings.MethodsA total of 132 primary care physicians, 4568 eligible patients with uncontrolled hypertension, and 15 392 eligible patients with uncontrolled dyslipidaemia were cluster-randomised to one of three conditions: (a) no intervention, (b) PPL-electronic medical record (EMR) intervention in which 12 PPL cases were assigned to each physician based on observed patterns of care in the EMR in the previous year, or (c) PPL-ASSESS intervention in which 12 PPL cases were assigned to each physician based on their performance on four standardised assessment cases. General and generalised linear mixed models were used to account for clustering and to model differences in patient outcomes in the study arms.ResultsAmong patients with uncontrolled hypertension at baseline, 49.1%, 46.6% and 47.3% (p=0.43) achieved blood pressure (BP) targets at follow-up. Among patients with uncontrolled dyslipidaemia at baseline, 37.5%, 37.3% and 38.1% (p=0.72) achieved low density lipoprotein cholesterol targets at follow-up in PPL-EMR, PPL-ASSESS and the control group, respectively. Although systolic (BP) (p<0.001) and lipid (p<0.001) values significantly improved during the study, the group-by-time interaction term showed no differential change in systolic BP values (p=0.51) or lipid values (p=0.61) among the three study arms. No difference in intervention effect was noted when comparing the PPL-EMR with the PPL-ASSESS intervention (p=0.47).ConclusionsThe two PPL interventions tested in this study did not lead to improved control of hypertension or dyslipidaemia in primary care clinics during a mean 14-month follow-up period. This null result may have been due in part to substantial overall improvement in BP and lipid control at the study sites during the study.Trial registration numberNCT00903071.

Project description:BackgroundImproving retention within randomised controlled trials is important. The effectiveness of different strategies can be assessed using a Study Within A Trial (SWAT). Previous research has shown personalised text message reminders improve clinic attendance rates; however, the results are mixed on improving postal questionnaire return. This SWAT aims to assess whether personalised text message reminders improve completion rates for scheduled telephone follow-ups.MethodsThis SWAT is a two-arm, multi-centre randomised controlled trial with equal allocation. The host trial was the Melatonin for Anxiety prior to General anaesthesia In Children trial (ISRCTN 18296119), where the child's caregiver was to answer a scheduled telephone follow-up 14 days post-surgery; participants for the SWAT were therefore the caregiver. Text messages were sent 24-48 h before the scheduled call and the personalised version contained the first name of the caregiver which was omitted in the non-personalised version. The primary outcome was questionnaire completion rate, defined as the proportion of caregivers successfully contacted, and completed any of the questionnaires, over the telephone within the follow-up window (day 14 + 7 days).ResultsThe SWAT included 100 of the 110 (91%) participants randomised into the host trial. Randomisation within the SWAT was equal between non-personalised (n = 50) and personalised (n = 50) interventions. The overall questionnaire response rate was 73% with a difference between the two interventions of 68% in the non-personalised text message arm and 78% in the personalised text message arm. The adjusted absolute risk difference was 7.1% (95% confidence interval = -10.2%, 24.4%). There was no difference in either the time to response or the number of contact attempts between the two interventions.ConclusionsThere is some evidence that personalised text messages could be effective at increasing response rates when data is collected via telephone and in a population of caregivers for paediatric trial participants. However, similar SWATs have shown mixed results. Given the low-cost and low risks associated with personalising text message reminders, this SWAT could be implemented easily in other RCTs scheduling telephone follow-up appointments.Trial registrationISRCTN 18296119 , SWAT 35 (MRC Northern Ireland Network for Trials Methodology Network).

Dataset Information

The effect of mobile personalised texting versus non-personalised texting on the caries risk of underprivileged adults: a randomised control trial.

Background

Methods

Results

Conclusions

Trial registration

Publications

The effect of mobile personalised texting versus non-personalised texting on the caries risk of underprivileged adults: a randomised control trial.

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