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Assessing loss to follow-up in the MObile Technology for Improved Family Planning (MOTIF) randomised controlled trial.

ABSTRACT: Loss to follow-up (LTFU) in clinical trials is an important source of bias that can affect statistical power and generalisability of findings. The aim of this paper is to assess factors associated with LTFU in the MObile Technology for Improved Family Planning (MOTIF) trial in Cambodia and compare how the result might have varied using different analytical methods.Follow-up in the MOTIF trial was 86% at 4 months and 66% at 12 months. For the primary analysis, we undertook a complete case analysis, similar to the approach used in similar trials of interventions delivered by mobile phone to increase contraception use. We conducted an exploratory analysis and found that factors associated with LTFU were young age, lower socio-economic status, not planning to use post-abortion contraception, availability of phone credit and not providing additional contact numbers. We then undertook two analyses to estimate the effect of the intervention on the primary outcome at 4 and 12 months for comparison with the complete case analysis. First, we undertook multiple imputation, and second we conducted an analysis treating all participants' LTFU as non-users of contraception.Using multiple imputation, we found that the risk ratio was slightly increased at 4 months and slightly decreased at 12 months compared with the complete case analysis. When counting all participants' LTFU as non-users of contraception, we observed that, compared with the complete case analysis, the risk ratio was slightly decreased at 4 months and slightly increased at 12 months. Despite the changes in the risk ratio, use of the different analytical methods did not result in an effect using the complete case analysis becoming statistically significant or vice versa.Future studies assessing contraception use might anticipate increased attrition amongst younger participants, those of lower socio-economic status or those who do not provide additional contact details. Attrition could be reduced by collecting as many contact details as possible, by providing incentives and possibly by enhanced counselling to groups at higher risk of LTFU on recruitment. Multiple imputation should be considered in addition to complete case analysis if LTFU not missing at random is expected or observed.ClinicalTrials.gov, NCT01823861 . Registered on 30 March 2013.

SUBMITTER: Smith C

PROVIDER: S-EPMC5709838 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Assessing loss to follow-up in the MObile Technology for Improved Family Planning (MOTIF) randomised controlled trial.

Smith Chris C Jarvis Christopher C Free Caroline C

Trials 20171201 1

<h4>Background</h4>Loss to follow-up (LTFU) in clinical trials is an important source of bias that can affect statistical power and generalisability of findings. The aim of this paper is to assess factors associated with LTFU in the MObile Technology for Improved Family Planning (MOTIF) trial in Cambodia and compare how the result might have varied using different analytical methods.<h4>Methods</h4>Follow-up in the MOTIF trial was 86% at 4 months and 66% at 12 months. For the primary analysis, w ...[more]

PMID: 29191231

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Project description:Providing women with contraceptive methods following abortion is important to reduce repeat abortion rates, yet evidence for effective post-abortion family planning interventions are limited. This protocol outlines the evaluation of a mobile phone-based intervention using voice messages to support post-abortion family planning in Cambodia.A single blind randomised controlled trial of 500 participants. Clients aged 18 or over, attending for abortion at four Marie Stopes International clinics in Cambodia, owning a mobile phone and not wishing to have a child at the current time are randomised to the mobile phone-based intervention or control (standard care) with a 1:1 allocation ratio.The intervention comprises a series of six automated voice messages to remind clients about available family planning methods and provide a conduit for additional support. Clients can respond to message prompts to request a phone call from a counsellor, or alternatively to state they have no problems. Clients requesting to talk to a counsellor, or who do not respond to the message prompts, receive a call from a Marie Stopes International Cambodia counsellor who provides individualised advice and support regarding family planning. The duration of the intervention is 3 months. The control group receive existing standard of care without the additional mobile phone-based support.We hypothesise that the intervention will remind clients about contraceptive methods available, identify problems with side effects early and provide support, and therefore increase use of post-abortion family planning, while reducing discontinuation and unsafe method switching.Participants are assessed at baseline and at 4 months. The primary outcome measure is use of an effective modern contraceptive method at 4 months post abortion. Secondary outcome measures include contraception use, pregnancy and repeat abortion over the 4-month post-abortion period.Risk ratios will be used as the measure of effect of the intervention on the outcomes, and these will be estimated with 95% confidence intervals. All analyses will be based on the 'intention to treat' principle.This study will provide evidence on the effectiveness of a mobile phone-based intervention using voice messages to support contraception use in a population with limited literacy. Findings could be generalisable to similar populations in different settings.ClinicalTrials.gov Identifier: NCT01823861.

Project description:BACKGROUND:A variety of different approaches to measuring contraceptive use have been used or proposed, either to assess current use or adherence over time, using subjective or objective measures. This paper reports an overview of approaches to measuring adherence to the oral contraceptive, intra-uterine device, sub-dermal implant, and injectable and describes how we assessed contraception use in the MObile Technology for Improved Family Planning (MOTIF) trial in Cambodia. MAIN BODY:We summarise and discuss advantages and disadvantages of different subjective and objective approaches to measuring adherence to the oral contraceptive, intra-uterine device, sub-dermal implant, and injectable such as self-reports, clinic records, electronic monitoring devices, clinical examination and biomarkers. For the MOTIF trial, we did not consider it feasible to measure objective contraception use as many participants lived a long distance from the clinic and we were concerned whether it was appropriate to ask women to return to clinic for a physical examination simply to verify self-report information already provided. We aimed to assess the validity of the four-month data with 50 participants, calculating the sensitivity and specificity of self-reported data compared with objective measurement. For the 46 valid measurements obtained, the sensitivity and specificity was 100% for self-reported contraception use compared to objective measurement but this study had some limitations. To assess reliability of self-report data we compared calendar data collected on effective contraception use at months 1-4 post-abortion, collected separately at four and 12 months. Agreement ranged from 80 to 84% with a kappa statistic ranging from 0·59 to 0·67 indicating fair to good agreement. CONCLUSION:There is no perfect method of assessing contraception use and researchers designing future studies should give consideration of what to measure, for example current use or detailed patterns of use over time, and remain mindful of what will be feasible and acceptable to the study population. Although self-reported data on contraception use are considered less reliable, and prone to social desirability bias, it is often the standard approach for contraception research and provides data comparable to previous studies. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT01823861 . Registered: March 30, 2013.

Project description:IntroductionMen who are overweight or obese in the rural Midwestern USA are an unrepresented, at-risk group exhibiting rising rates of cardiovascular disease, poor access to preventive care and poor lifestyle behaviours that contribute to sedentary lifestyle and unhealthy diet. Self-monitoring of eating and activity has demonstrated efficacy for weight loss. Use of mobile technologies for self-monitoring eating and activity may address rural men's access disparities to preventive health resources and support weight loss. Our pilot trial will assess the feasibility and acceptability of two mobile applications for weight loss in rural men to inform a future, full-scale trial.Methods and analysisA 6-month randomised controlled trial with contextual evaluation will randomise 80 men using a 1:1 ratio to either a Mobile Technology Plus (MT+) intervention or a basic Mobile Technology (MT) intervention in rural, midlife men (aged 40-69 years). The MT+ intervention consists of a smartphone self-monitoring application enhanced with discussion group (Lose-It premium), short message service text-based support and Wi-Fi scale. The MT group will receive only a self-monitoring application (Lose-It basic). Feasibility and acceptability will be evaluated using number of men recruited and retained, and evaluative focus group feedback. We seek to determine point estimates and variability of outcome measures of weight loss (kg and % body weight) and improved dietary and physical activity behaviours (Behavioral Risk Factor Surveillance System (BRFSS) physical activity and fruit and vegetable consumption surveys, data from Lose-It! application (kcal/day, steps/day)). Community capacity will be assessed using standard best practice methods. Descriptive content analysis will evaluate intervention acceptability and contextual sensitivity.Ethics and disseminationThis protocol was approved by the University of Nebraska Medical Center Institutional Review Board (IRB# 594-17-EP). Dissemination of findings will occur through ClinicalTrials.gov and publish pilot data to inform the design of a larger clinical trial.Trial registration numberNCT03329079; preresults. Protocol V.10, study completion date 31 August 2020. Roles and responsibilities funder: NIH/NINR Health Disparities Section 1R15NR017522-01.

Project description:BACKGROUND:In 2013, the Organ Procurement and Transplantation Network began requiring transplant centers in the United States to collect and report postdonation living kidney donor follow-up data at 6 months, 1 year, and 2 years. Despite this requirement, <50% of transplant centers have been able to collect and report the required data. Previous work identified a number of barriers to living kidney donor follow-up, including logistical and administrative barriers for transplant centers and cost and functional barriers for donors. Novel smartphone-based mobile health (mHealth) technologies might reduce the burden of living kidney donor follow-up for centers and donors. However, the attitudes and perceptions toward the incorporation of mHealth into postdonation care among living kidney donors are unknown. Understanding donor attitudes and perceptions will be vital to the creation of a patient-oriented mHealth system to improve living donor follow-up in the United States. OBJECTIVE:The goal of this study was to assess living kidney donor attitudes and perceptions associated with the use of mHealth for follow-up. METHODS:We developed and administered a cross-sectional 14-question survey to 100 living kidney donors at our transplant center. All participants were part of an ongoing longitudinal study of long-term outcomes in living kidney donors. The survey included questions on smartphone use, current health maintenance behaviors, accessibility to health information, and attitudes toward using mHealth for living kidney donor follow-up. RESULTS:Of the 100 participants surveyed, 94 owned a smartphone (35 Android, 58 iPhone, 1 Blackberry), 37 had accessed their electronic medical record on their smartphone, and 38 had tracked their exercise and physical activity on their smartphone. While 77% (72/93) of participants who owned a smartphone and had asked a medical question in the last year placed the most trust with their doctors, nurses, or other health care professionals regarding answering a health-related question, 52% (48/93) most often accessed health information elsewhere. Overall, 79% (74/94) of smartphone-owning participants perceived accessing living kidney donor information and resources on their smartphone as useful. Additionally, 80% (75/94) perceived completing some living kidney donor follow-up via mHealth as useful. There were no significant differences in median age (60 vs 59 years; P=.65), median years since donation (10 vs 12 years; P=.45), gender (36/75, 36%, vs 37/75, 37%, male; P=.57), or race (70/75, 93%, vs 18/19, 95%, white; P=.34) between those who perceived mHealth as useful for living kidney donor follow-up and those who did not, respectively. CONCLUSIONS:Overall, smartphone ownership was high (94/100, 94.0%), and 79% (74/94) of surveyed smartphone-owning donors felt that it would be useful to complete their required follow-up with an mHealth tool, with no significant differences by age, sex, or race. These results suggest that patients would benefit from an mHealth tool to perform living donor follow-up.

Dataset Information

Assessing loss to follow-up in the MObile Technology for Improved Family Planning (MOTIF) randomised controlled trial.

Publications

Assessing loss to follow-up in the MObile Technology for Improved Family Planning (MOTIF) randomised controlled trial.

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