Dataset Information

A supportive text message intervention for individuals living with endometriosis (EndoSMS): Randomized controlled pilot and feasibility trial.

ABSTRACT:

Introduction

As a high symptom burden chronic condition, endometriosis is associated with diminished quality of life (QoL) and psychological distress. The EndoSMS text message intervention was developed to inform and support individuals living with endometriosis. The primary aim of this study is to assess the acceptability, feasibility and preliminary efficacy of EndoSMS, to improve endometriosis-specific QoL and reduce psychological distress in a randomised controlled trial, compared with care as usual. We will additionally assess the impact of EndoSMS on self-efficacy for managing endometriosis.

Methodology

A two-arm parallel pilot randomised controlled trial with waitlist control was conducted. Baseline assessments included QoL, psychological distress, self-efficacy, demographic and medical variables. Following baseline survey completion, participants were randomised to either the Intervention (EndoSMS: 3-months of text messaging) or Control condition. At 3-month follow-up, all participants completed an online survey reassessing outcomes, and Intervention participants provided quantitative and qualitative user feedback on EndoSMS.

Results

Data collection commenced on 18 November 2021 and was completed on 30 March 2022. Descriptive statistics will be used to analyse feasibility and acceptability of the intervention. Preliminary efficacy analyses will be conducted using linear mixed models for QoL, psychological distress and self-efficacy outcomes. Subgroup analyses will also be conducted for typically underserved populations (e.g., rural/regional).

Conclusion

This pilot will provide acceptability, feasibility and preliminary efficacy evidence for the impact of a supportive text messaging program for endometriosis. It will contribute to understanding how to optimally support individuals in living with and managing their endometriosis.

Trial registration

Australian New Zealand Clinical Trials Registry.

SUBMITTER: Sherman KA

PROVIDER: S-EPMC9989515 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Publications

A supportive text message intervention for individuals living with endometriosis (EndoSMS): Randomized controlled pilot and feasibility trial.

Sherman Kerry A KA Pehlivan Melissa J MJ Redfern Julie J Armour Mike M Dear Blake B Singleton Anna A Duckworth Tanya T Ciccia Donna D Cooper Michael M Hawkey Alex A Parry Kelly A KA Gandhi Esther E

Contemporary clinical trials communications 20230218

<h4>Introduction</h4>As a high symptom burden chronic condition, endometriosis is associated with diminished quality of life (QoL) and psychological distress. The EndoSMS text message intervention was developed to inform and support individuals living with endometriosis. The primary aim of this study is to assess the acceptability, feasibility and preliminary efficacy of EndoSMS, to improve endometriosis-specific QoL and reduce psychological distress in a randomised controlled trial, compared wi ...[more]

PMID: 36895681

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Project description:BackgroundEndometriosis, which affects 1 in 10 people assigned female at birth, is a chronic systemic inflammatory disease with a high symptom burden and adverse socioemotional impacts. There is a need for an accessible, cost-effective, and low-burden intervention to support individuals in managing their endometriosis condition.ObjectiveThis study aimed to co-design and evaluate the acceptability, readability, and quality of a bank of supportive SMS text messages (EndoSMS) for individuals with endometriosis.MethodsIn phase 1 of this mixed method design, 17 consumer representatives (individuals with endometriosis) participated across three 3-hour web-based (Zoom, Zoom Video Communications, Inc) focus groups. The transcripts were encoded and analyzed thematically. In phase 2, consumer representatives (n=14) and health care professionals (n=9) quantitatively rated the acceptability, readability, and appropriateness of the developed text messages in a web-based survey. All the participants initially completed a background survey assessing sociodemographic and medical factors.ResultsConsumer representatives demonstrated diverse sociodemographic characteristics (Mage=33.29), varying in location (metropolitan vs rural or regional), employment, and relationship and educational statuses. Participants reached a consensus regarding the delivery of 4 SMS text messages per week, delivered randomly throughout the week and in one direction (ie, no reply), with customization for the time of day and use of personal names. Seven main areas of unmet need for which participants required assistance were identified, which subsequently became the topic areas for the developed SMS text messages: emotional health, social support, looking after and caring for your body, patient empowerment, interpersonal issues, general endometriosis information, and physical health. Through a web-based survey, 371 co-designed SMS text messages were highly rated by consumers and health care professionals as clear, useful, and appropriate for individuals with endometriosis. Readability indices (Flesch-Kincaid scale) indicated that the SMS text messages were accessible to individuals with a minimum of 7th grade high school education.ConclusionsOn the basis of the needs and preferences of a diverse consumer representative group, we co-designed EndoSMS, a supportive SMS text message program for individuals with endometriosis. The initial evaluation of the SMS text messages by consumer representatives and health professionals suggested the high acceptability and suitability of the developed SMS text messages. Future studies should further evaluate the acceptability and effectiveness of EndoSMS in a broader population of individuals with endometriosis.

Project description:BACKGROUND:Little is known about the feasibility and acceptability of tailored text message based weight loss programs for English and Spanish-language speakers. OBJECTIVE:This pilot study evaluated the feasibility, acceptability, and estimated impact of a tailored text message based weight loss program for English and Spanish-language speakers. The purpose of this pilot study was to inform the development of a full-scale randomized trial. METHODS:There were 20 overweight or obese participants (mean age 40.10, SD 8.05; 8/20, 40% male; 9/20, 45% Spanish-speakers) that were recruited in San Diego, California, from March to May 2011 and evaluated in a one-group pre/post clinical trial. For 8 weeks, participants received and responded to 3-5 text messages daily sent from a fully automated text messaging system. They also received printed weight loss materials and brief 10-15 minute weekly counseling calls. To estimate the impact of the program, the primary outcome was weight (kg) measured during face-to-face measurement visits by trained research staff. Pre and post differences in weight were analyzed with a one-way repeated measures analysis of variance. Differences by language preference at both time points were analyzed with t tests. Body mass index and weight management behaviors also were examined. Feasibility and acceptability were determined by recruitment success, adherence (ie, percentage of replies to interactive text messages and attrition), and participant satisfaction. RESULTS:Participants who completed the final assessment (N=18) decreased body weight by 1.85 kg (F1,17=10.80, P=.004, CI? 0.66-3.03, ?(2)=0.39). At both time points, there were no differences in weight by language preference. Participants responded to 88.04% (986/1120) of interactive text messages, attrition rate was 10% (2/20), and 94% (19/20) of participants reported satisfaction with the program. CONCLUSIONS:This fully automated text message based weight program was feasible with English and Spanish-speakers and may have promoted modest weight loss over an 8-week period. TRIAL REGISTRATION:Clinicaltrials.gov NCT01171586; http://clinicaltrials.gov/ct2/show/NCT01171586 (Archived by WebCite at http://www.webcitation.org/6Ksr6dl7n).

Project description:ObjectiveTo evaluate the feasibility of a randomized controlled pilot study with lifestyle-promoting text messages as a treatment for hypertension in primary care.DesignRandomized controlled pilot trial.SettingThree primary health care centers in southern Sweden.SubjectsSixty patients aged 40-80 years with hypertension were included.Main outcome measuresFeasibility of the pilot study, i.e. recruitment rate, dropout rate and eligibility criteria. Secondary outcomes were change in blood pressure and other cardiovascular risk factors.MethodsThirty participants were randomized to the intervention group with four lifestyle-promoting text messages sent every week for six months. The control group received usual care. The baseline and follow-up visits for all 60 patients included measurements of blood pressure, anthropometrics, blood tests and a self-reported questionnaire.ResultsAll feasibility criteria (recruitment rate (≥55%), dropout rate (≤15%) and eligibility (60 eligible patients during the four-month inclusion period) for the pilot study were fulfilled. This means that a larger study with a similar design may be conducted. After six months, there were no significant improvements in cardiovascular risk factors. However, we found favorable trends for all secondary outcomes in the intervention group as compared to the control group.ConclusionLifestyle modification in patients with hypertension is important to reduce cardiovascular risk. However, primary healthcare has limited resources to work with modifying lifestyle habits. This is the first pilot study to test the feasibility of text message-based lifestyle intervention in patients with hypertension in Swedish primary healthcare. Whether significant improvement in cardiovascular risk factors may be achieved in a larger study population remains to be evaluated. Key points This pilot randomized controlled trial (RCT) is the first study to evaluate the feasibility of text message-based lifestyle advice to patients with hypertension in Swedish primary healthcare. •All feasibility criteria for the pilot study were fulfilled. This outcome means that a larger study with a similar design may be conducted. •The study was not powered to find significant changes in cardiovascular risk factors. Nevertheless, after six months we found favorable trends for all secondary outcomes in the intervention group compared to control. •If a future larger study can show significant results, this intervention could serve as a useful tool in everyday primary healthcare.

Project description:BackgroundMost people living with HIV (PLWH) reside in middle- and low-income countries with limited access to health services. Thus, cost-effective interventions that can reach a large number of PLWH are urgently needed.ObjectiveThe objective of our study was to assess the feasibility and acceptability of an mHealth intervention among PLWH in China.MethodsBased on previous formative research, we designed an mHealth intervention program that included sending weekly reminders to participants via text messages (short message service, SMS) and articles on HIV self-management three times a week via a popular social media app WeChat. A total of 62 PLWH recruited from an HIV outpatient clinic were randomly assigned to intervention or control group. The intervention lasted for 3 months, and all participants were assessed for their medication adherence, presence of depression, quality of life (QoL), and CD4 (cluster of differentiation 4) counts. Upon completing the intervention, we interviewed 31 participants to further assess the feasibility and acceptability of the study.ResultsAt baseline, the intervention and control groups did not differ in terms of demographic characteristics or any of the major outcome measures. About 85% (53/62) of the participants completed the intervention, and they provided valuable feedback on the design and content of the intervention. Participants preferred WeChat as the platform for receiving information and interactive communication for ease of access. Furthermore, they made specific recommendations about building trust, interactive features, and personalized feedback. In the follow-up assessment, the intervention and control groups did not differ in terms of major outcome measures.ConclusionsThis pilot study represents one of the first efforts to develop a text messaging (SMS)- and WeChat-based intervention that focused on improving the medication adherence and QoL of PLWH in China. Our data indicates that an mHealth intervention is feasible and acceptable to this population. The data collected through this pilot study will inform the future designs and implementations of mHealth interventions in this vulnerable population. We recommend more innovative mHealth interventions with rigorous designs for the PLWH in middle- and low-income countries.Trial registrationChinese Clinical Trial Registry ChiCTR1800017987; http://www.chictr.org.cn/showprojen.aspx?proj=30448 (Archived by WebCite at http://www.webcitation.org/71zC7Pdzs).Registered report ientifierRR1-10.2196/.

Project description:IntroductionDespite the high burden of tobacco use in India, users do not have access to adequate help. This pilot trial aimed to evaluate the feasibility and acceptability of a text messaging intervention for tobacco cessation, generate preliminary estimates of its impact, and fine-tune procedures for a definitive trial.Aims and methodsParallel two-arm single blind individually randomized controlled pilot trial with nested qualitative study. Participants included adult current tobacco users (smoked and smokeless). Eligible and consenting participants were randomized to receive either (1) text messaging intervention (ToQuit) which covered specific content areas such as psychoeducation about consequences of tobacco use and benefits of quitting and tobacco avoidance strategies or (2) information about tobacco cessation helplines such as the helpline number and the languages in which tobacco cessation support was available (control). Feasibility data included screening and consent rates, treatment dropouts, and outcome ascertainment. The primary abstinence outcome was self-reported abstinence from tobacco in the past seven days at 3 months post-randomization. In-depth interviews were conducted with a subsample of participants primarily to collect acceptability data. The primary abstinence analysis used a chi-squared test and logistic regression (complete case), and qualitative data was analyzed using thematic analysis.ResultsNinety-eight participants were randomized into the two trial arms; 77 (79%) completed outcome evaluation. No between-arm differences in abstinence were found though findings favored the intervention (7-day abstinence: ToQuit 23%, control 19%; adjusted odds ratio 1.23, 95% confidence interval 0.38, 3.97). Participants appreciated the language, comprehensibility, and relevance of the messages; and reported overall satisfaction with and positive impact from the intervention on their lives.ConclusionsThe findings indicate the acceptability and feasibility of ToQuit and if found effective, it could be a potentially scalable first-line response to tobacco use in low-resource settings.ImplicationsOur pilot randomized control trial provides sufficient findings supporting the acceptability and feasibility of an intervention for tobacco cessation which is suitable for a context which has a shortage of healthcare workers and for individuals who use smoked or smokeless tobacco. This is critical on a background of limited contextually relevant interventions for a problem with a high burden in low- and middle-income countries such as India.

Dataset Information

A supportive text message intervention for individuals living with endometriosis (EndoSMS): Randomized controlled pilot and feasibility trial.

Introduction

Methodology

Results

Conclusion

Trial registration

Publications

A supportive text message intervention for individuals living with endometriosis (EndoSMS): Randomized controlled pilot and feasibility trial.

Similar Datasets

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