Participant Adherence Research Articles

Exploring how researchers consider nutrition trial design and participant adherence: a theory-based analysis

IntroductionNutrition trials are important for informing dietary and clinical guidelines. Central to the success of these trials is participant adherence to dietary behaviors. However, trials commonly experience poor adherence. This study seeks to understand if and how researchers consider supporting participant adherence to dietary behaviors and their relationship to using behavior change science when designing trials.MethodsA mapping exercise was undertaken to create matrices that describe the landscape of current nutrition trials. A total of 12 researchers participated in semi-structured, one-on-one interviews. Transcripts were analyzed using (i) the theoretical domains framework (TDF) to identify themes in current practice and beliefs, and (ii) the capability, opportunity, motivation, and behavior model to identify barriers and enablers to using behavior change science in the design of nutrition trials.ResultsTwenty-two belief statements were identified across all 14 TDF domains and were conceptualized as 5 key themes with respect to designing nutrition trials to improve participant adherence: (i) what was done, (ii) how it was done, (iii) why it was done, (iv) adherence challenges, and (v) conflicting beliefs. Regarding using behavior change science when designing trials, some researchers felt this would be beneficial but lacked the knowledge and skills to do so, while others were skeptical of its value over the current experience-based practice.DiscussionResearchers are motivated to encourage participant adherence to dietary behaviors, and, consciously and subconsciously, implement a range of strategies through non-systematic methods in their trials. Future publications would benefit from the explicit documentation of levels of adherence to dietary behaviors and strategies implemented to improve adherence.

Initial participant perspectives about participating in an online, semi-supervised, cirrhosis-specific nutrition and exercise intervention.

In chronic diseases, there have been issues with low levels of participant adherence and retention during well-supported lifestyle behaviour change interventional studies. Theoretically informed, the objective was to explore the types of challenges participants are experiencing to inform future designs. We conducted an exploratory descriptive study in an adult cirrhosis population after the first 4-6 weeks of a 12-week semi-supervised nutrition and exercise online program. Participants in the parent feasibility study, assessing the nutrition and exercise intervention (Heal-Me), were eligible for this nested study. Heal-Me is a multimodal program that is tailorable to a participant's abilities through regular interaction with the study's registered dietician and exercise specialist. Interviews (~60 min) with participants were recorded then analysed descriptively, guided by the capability, opportunity and motivational behaviour change model. The 20 participants preferred the expert-led group online nutrition and exercise classes over independent activities such as protein tracking and the exercise videos. Social gamification (e.g., weekly polls on favourite things like movies or sports teams) contributed to the group experience. All except one person required program tailoring to address preferences, abilities and new onset health events. Findings led to the inclusion of 4 behaviour change techniques to the initial 17, whereas 2 others were expanded. While program tailoring, awareness of cirrhosis nutrition and regular interactions with staff influenced participant retention and adherence in the first 4-6 weeks of the online program.

Personalized Smartphone-Enabled Assessment of Blood Pressure and Its Treatment During the SARS-CoV-2 COVID-19 Pandemic in Patients From the CURE-19 Study: Longitudinal Observational Study.

The use of digital interventions by patients for remote monitoring and management of health and disease is increasing. This observational study examined the feasibility, use, and safety of a digital smartphone app for routine monitoring of blood pressure (BP), medication, and symptoms of COVID-19 during the COVID-19 pandemic. The objective of this study was to deploy and test electronic data recording using a smartphone app developed for routine monitoring of BP in patients with primary hypertension. We tested the app for ease of data entry in BP management and tracking symptoms of new-onset COVID-19 to determine if participants found this app approach useful and sustainable. This remote, decentralized, 12-week, prospective, observational study was conducted in a community setting within the United States. Participants were approached and recruited from affiliated sites where they were enrolled in an ongoing remote decentralized study (CURE-19) of participants experiencing the COVID-19 pandemic. Potential participants were asked to complete a digital screener to determine eligibility and given informed consent forms to read and consent to using the Curebase digital platform. Following enrollment, participants downloaded the digital app to their smartphones for all data collection. Participants recorded daily BP, associated medication use, and emergent symptoms associated with SARS-CoV-2 infection. In addition, usability (adherence, acceptability, and user experience) was assessed using standard survey questions. Adverse events were collected based on participant self-report. Compliance and engagement were determined from user data entry rates. Feasibility and participant feedback were assessed upon study completion using the User Experience Questionnaire. Of the 389 participants who enrolled in and completed the study, 380 (98%) participants downloaded and entered BP routines in week 1. App engagement remained high; 239 (62.9%) of the 380 participants remained in the study for the full 12-week observation period, and 201 (84.1%) of the 239 participants entered full BP routines into the digital app 80% or more of the time. The smartphone app scored an overall positive evaluation as assessed by the User Experience Questionnaire and was benchmarked as "excellent" for domains of perspicuity, efficiency, and dependability and "above average" for domains of attractiveness and stimulation. Highly adherent participants with hypertension demonstrated well-controlled BP, with no significant changes in average systolic or diastolic BP between week 1 and week 12 (all P>.05). Participants were able to record BP medications and symptoms of SARS-CoV-2 infection. No adverse events attributable to the use of the smartphone app were reported during the observational period. The high retention, engagement and acceptability and positive feedback in this study demonstrates that routine monitoring of BP and medications using a smartphone app is feasible for patients with hypertension in a community setting. Remote monitoring of BP and data collection could be coupled with hypertensive medication in a combination product (drug+digital) for precision management of hypertension.

Evaluating the feasibility of “Friends in Nature,” a complex nature-based social intervention to address loneliness and quality of life in six cities worldwide

BackgroundLoneliness, a major public health concern, could be alleviated through social interventions with nature contact as a primary component. “Friends in Nature” is a complex nature-based social intervention designed to be implemented as part of “Reimagining Environments for Connection and Engagement: Testing Actions for Social Prescribing in Natural Spaces" (RECETAS). This project aims to alleviate loneliness and promote health-related quality of life in six different geographic areas worldwide. Feasibility studies are crucial to assess the viability of complex interventions and study procedures before conducting definitive studies. This paper aims to describe the design, implementation, and evaluation of the six-related feasibility studies on the “Friends in Nature” intervention. These studies specifically evaluate feasibility of recruitment and study procedures, intervention implementation, and data collection and distribution.MethodsWe defined a comprehensive set of indicators to assess the feasibility of “Friends in Nature.” For the first domain, recruitment procedures were assessed to determine their adequacy, while attrition rates were examined to assess participant retention. For the second domain, the implementation of interventions was evaluated, along with the study design’s ability to adapt to unexpected situations and participant adherence to the intervention. Finally, for the third domain, completion rates and the acceptability of the study activities were also analyzed. The feasibility of using specific scales to assess loneliness and well-being was also explored.ResultsThe feasibility indicators defined for this study were useful to assess the feasibility of “Friends in Nature.” Recruitment procedures were generally found to be adequate, and the number of dropouts was low. Interventions were implemented with minor adjustments, and facilitators played a vital role in the well-functioning of the interventions. Although some unexpected situations occurred during the study, adaptations were made, and participants were generally satisfied with the activities proposed. Scales used to assess loneliness and quality of life showed potential for measuring the effects of nature-based social prescribing in the full trial.ConclusionThis paper offers valuable insights into the design and execution of feasibility studies for complex interventions like “Friends in Nature.” Findings from these assessments explore the feasibility of “Friends in Nature” and will inform the main RECETAS studies, which are designed to strengthen the evidence base to support the use of nature-based social prescribing to reduce loneliness and promote quality of life.Trial registrationBarcelona trial: NCT05488496, Prague trial: NCT05522140, and Helsinki trial: NCT05507684.

Effectiveness and cost-effectiveness of guided self-help for depression for autistic adults: the Autism Depression Trial (ADEPT-2) – protocol for a multicentre, randomised controlled trial of a remotely delivered low-intensity intervention

IntroductionDepression is three to four times more prevalent in autistic people and is related to reduced quality of life. There is a need for empirically supported psychological interventions for depression...

Use of the Time-Based Experience Sampling Method in Older Adults

Abstract: Older adults represent an increasing proportion of the world’s population and are an important target group for psychological research. The experience sampling method (ESM) has the potential to generate unique insights into the daily lives of older adults, but its application also brings challenges. We provide a systematic review of studies applying time-based ESM (tb-ESM) with participants of 65 years and older in their natural environment, focusing on the studies’ specific (1) (sub)populations and contexts, (2) tb-ESM designs, and (3) rate of study adherence. We searched Medline, Web of Science, Cinahl, Psychology Database, and OSF preprints for eligible reports published from 2007 onwards. After screening 549 records, 54 reports on 31 unique studies were included in the narrative synthesis. Most studies sampled healthy community-dwelling older adults and applied semi-randomized signal schedules. Mobile assessments were much more common than in an earlier review with studies published before 2007 and could be implemented successfully. Recommendations for future tb-ESM studies in older adults are made regarding training and follow-up, custom signal modalities and schedules, and adapted response recording methods. Future aging tb-ESM studies should be mindful of the inclusion of more diverse samples and the evaluation of participant adherence and burden.

Abstract A064: Lung cancer screening adherence among participants in DETECT-A, the first prospective interventional trial of a multi-cancer early detection (MCED) blood test

Abstract Background: Lung cancer is the leading cause of cancer death in the US. Adherence to guideline- recommended low-dose computed tomography screening is poor and late-stage diagnosis is common. MCED tests may improve early cancer detection if adherence to guideline- recommended single cancer screening is maintained. The DETECT-A study evaluated an MCED test in 9,911 women in Geisinger Health System (GHS), age 65-75, without personal cancer history. This analysis evaluates lung cancer screening adherence among DETECT-A participants to determine if adherence changed significantly following receipt of an MCED test. Methods: Monthly screening eligibility and adherence data (2013 USPSTF criteria) were available from September 2016 - May 2020 for DETECT-A participants and screening-eligible women in GHS who met DETECT-A eligibility criteria but did not participate in DETECT-A. A control group was constructed by randomly selecting GHS non-participants at a 7:1 ratio and assigning index months that matched the distribution of consent months for DETECT-A participants. All analyzed participants had ≥24 consecutive months of adherence data centered around the consent/index month. The proportion adherent at consent/index month and the end of active study participation at 12 months were calculated descriptively. Changes in adherence over time, as well as group comparisons, were assessed using a mixed effects logistic regression model. Results: DETECT-A participants (n=364) and controls (n=2,548) had similar age, race, and ethnicity distributions. The population was predominantly white (>98%) and non-Hispanic (>90%). The odds of adherence at 12 months were significantly higher than at consent/index for both DETECT-A participants (OR: 3.20 [1.04 -9.80], p=0.042) and controls (OR: 2.02 [1.23- 3.33], p=0.006). The increase in odds of adherence between consent/index and 12 months was not significantly different between the groups (OR: 1.58 [0.47-5.31], p=0.461). DETECT-A participant adherence was 28.0% (23.4%-32.6%) in the consent month and increased to 38.5% (33.5-43.5%) at 12 months. Among the 102 DETECT-A participants adherent in the consent month, 70 (68.6%) were also adherent at 12 months. Control adherence was 16.0% (14.6%-17.4%) in the index month and increased to 20.2% (18.7%-21.8%) at 12 months. Among 408 controls adherent in the index month, 257 (63.0%) were also adherent at 12 months. Conclusions: DETECT-A participation did not negatively affect lung cancer screening adherence among this subset of participants. Screening adherence increased over time in both DETECT-A participants and controls; most DETECT-A participants adherent in the study consent month were also adherent 12 months later. Effectiveness of GHS screening programs, DETECT-A participant self-selection, and DETECT-A educational efforts promoting screening may have contributed to these observations. Citation Format: Adam H. Buchanan, Anne Marie Lennon, Paul Z. Elias, Amy M. Lehman, Yongqiang Zhang, Darl D. Flake II, Eric S. Wagner, Seema P. Rego, Omair A. Choudhry, Nickolas Papadopoulos, Tomasz M. Beer. Lung cancer screening adherence among participants in DETECT-A, the first prospective interventional trial of a multi-cancer early detection (MCED) blood test [abstract]. In: Proceedings of the AACR Special Conference: Liquid Biopsy: From Discovery to Clinical Implementation; 2024 Nov 13-16; San Diego, CA. Philadelphia (PA): AACR; Clin Cancer Res 2024;30(21_Suppl):Abstract nr A064.

Deployment of the Icope program in oncogeriatrics

The World Health Organization recommends the use of the Integrated Care for Older People program to prevent the onset of dependency and enable seniors to age as they wish. In oncogeriatrics, it can be offered before or after the therapeutic project to any autonomous patient in order to monitor their intrinsic capacity. The experience of the Toulouse University Hospital shows the value of this follow-up in oncogeriatrics and the adherence of participants.

Lessons to learn from pilot studies in clinical trials: The example of a trauma‐focused treatment for female survivors of intimate partner violence

AbstractBackgroundResearch on pilot studies is scarce, despite their importance for the development of effective clinical trials. There is a lack of work addressing the process, limitations and strategies derived from these studies. This gap is even more evident in research studying targeted populations, such as victims of intimate partner violence (IPV), who present specific difficulties, such as high dropout rates, or require the application of challenging treatments, such as trauma‐focussed exposure therapy.AimThis paper describes a pilot study (PS) implemented as a preliminary step in the development of a clinical trial (CT), in which a trauma‐focussed treatment for survivors of IPV with post‐traumatic symptomatology was applied. The problems identified in the PS and the solutions that were implemented in the CT are described. Additionally, comparisons between the PS and CT with respect to participant adherence to treatment and satisfaction, as perceived by the participants and the therapist, are analysed.ResultsResults indicate that satisfaction with the treatment was high in both studies; dropouts showed a significant decrease in the CT (25% in CT vs. 75% in the PS; p = .028), while group cohesion increased.ConclusionsIt is concluded that conducting pilot studies allows adapting treatments to the study population, which seems to increase the quality of clinical trials, subsequently improving the evidence of psychological interventions.

Effects of Standard Tai Chi on Exercise Capacity and Mental Health in Exercise-Deprived Overweight/Obese Adults and Assessment of Participant Adherence.

To explore the effects of Tai Chi on body mass index (BMI), exercise capacity, and mental health of overweight/obese adults, and investigate factors influencing adherence to enhance adherence of Tai Chi as a sustainable exercise method. A randomized, controlled, exploratory clinical trial was conducted paired with a qualitative study of adherence management. A total of 20 overweight/obese participants were randomly assigned to a standard Tai Chi group (experimental) and a simplified Tai Chi group (control) for an 8-week intervention, 10 patients in each group, with a 12-month follow-up. BMI was calculated and exercise capacity including an isokinetic muscle strength and balance ability test were evaluated. Mental health was assessed using the General Well-Being Schedule (GWB), Pittsburgh Sleep Quality Index (PSQI), and Coping Self Efficacy Scale (CSES) at baseline, 4th week, and 8th week, respectively. The qualitative research included open-interviews with Tai Chi practitioners and semi-structured interviews with subjects. The intervention was conducted in Haidian Park, Beijing, China from October 6, 2022, to January 1, 2023, without dropouts. After an 8-week intervention, the participants in the experimental group exhibited a significant decrease in BMI (P<0.05). Both groups demonstrated significant improvements in exercise capacity (P<0.05). The experimental group exhibited a significant enhancement in the GWB, PSQI and CSES (P<0.05). Only GWB had significant difference in the control group (P<0.05). The experimental group surpassed the control group in GWB and CSES (P<0.05). The adherence rate was 87.5% in the experimental group and 57.9% in the control group after 8 weeks intervention. Analysis on adherence identified 15 themes, the top 3 themes mentioned were as follows: mind-body effects, online and on-site guidance, training schedule (for subjects); mind-body effects, difficulties in practicing, and understanding of Tai Chi (for practitioners). Both interventions were effective in improving exercise capacity. Tai Chi, integrating both physical and mental conditioning, reduced weight, improved exercise capacity and mental happiness, and increased adherence, providing a sustainable exercise program (ChiCTR2200063599).

Video Game-Based Trunk Exercises for Rehabilitation in Chronic Stroke Survivors: A Mixed-Methods Feasibility Study.

Aim: To assess the feasibility of video game-based trunk exercises using the Valedo® system in a chronic stroke population. Method: Ten chronic stroke survivors (eight males and two females, mean age 63 ± 15 years) were asked to complete 18 intervention sessions, each lasting 45 min., over 6-8 weeks. Feasibility was evaluated quantitatively using the Psychosocial Impact of Assistive Devices Scale (PIADS) as well as through recruitment, retention, adherence, and safety measures. Qualitative data on feasibility were collected through post-intervention semi-structured interviews. Descriptive analysis was used to summarize participant characteristics, recruitment, retention, and adherence. Qualitative data were analyzed using thematic analysis of the interviews. Results: Twelve stroke survivors were recruited from Southampton (United Kingdom) and Riyadh (Kingdom of Saudi Arabia), with two participants dropping out after the baseline assessment session. The remaining ten participants completed the study with a mean adherence of 96.11% to the planned sessions. No serious adverse effects were reported, however, four participants did experience trunk muscle tightness and fatigue. Post-intervention interviews revealed that participants encountered some physical and cognitive challenges while playing the Valedo video games. However, they felt that the implementation of trunk exercises using video games was safe, as the exercises were performed in a secure environment and in safe positions. Conclusions: The findings suggest that the Valedo system is feasible for delivering trunk exercises to chronic stroke survivors. Several factors should be considered when implementing this type of intervention in the future.

Feasibility of a 10-week community-based mobile health rehabilitation program using the WalkWithMe application in late sub-acute and chronic stroke survivors in a low resource setting: A pilot study

ABSTRACT Physical functioning can be increased in people with stroke by using a mobile health application. This study aimed to investigate the feasibility of a 10-week community-based program using the WalkWithMe (WWM) application in people with late sub-acute and chronic stroke in Benin. An interventional pilot study with mixed methods research design was used examining the application of an unsupervised individualized mobile Health (mHealth) instructed training program. Main outcome included the application usage, safety, adherence, perceived enjoyment, mHealth quality, patient experiences and pre-post efficacy measures. Nine adults, five males, median age of 60 years and time since stroke of 12 months participated in this study. For most participants adherence with the application was over 70%. However, some usability problems were observed due to incorrect understanding and use by participants and technical problems. The application was very fun, stimulating and enjoyable. Significant improvements were found with median (pre/post measures) of locomotors skill (1.4/3.4); impairments (38/40), Barthel Index (85/95), activity limitation (2.1/3.1), and quality of life (194/218). A trend towards significant improvement was found with 6 minutes walking test (181/220, p = 0.06). The WWM application is perceived as a potential approach to increase physical activity and functioning among people with stroke in Benin.

Impact of family engagement on client participation in coordinated specialty care for first episodes of psychosis

BackgroundCoordinated specialty care (CSC) programs for first episodes of psychosis are increasingly offered in the United States. A component of CSC programs is active family engagement in treatment, though research on the impact of this engagement is limited. This study examined the characteristics of families engaged compared to families not engaged in treatment, and the impact of family engagement on client participation and medication adherence over the first 6 months of treatment.MethodsUsing data from the Early Psychosis Intervention Network (EPINET) research hub in Minnesota (EPI-MINN), we compared two groups of individuals: clients who had a family member(s) engaged in their treatment vs. clients who did not. Family engagement was defined as any treatment services provided to a family member(s) by CSC clinical staff. The groups were compared on intake demographic variables, duration of untreated psychosis (DUP), hospitalizations, symptom severity, and functioning. A comparison of the total number of treatment visits during the first 6 months of treatment was tested using both nonparametric (Mann Whitney U) and parametric (ANCOVA) tests. Group comparisons on self ratings of “intent to attend visits,” “intent to complete the program,” and medication adherence were tested with ANCOVA and Chi-Square.ResultsFamily-engaged clients were younger, with less years of education, and more often White; clients without family engagement were more often Black. Family engagement was positively associated with increased total number of visits for all interventions with the exceptions of client peer support and case management visits. Family engagement increased clients’ self-reported intent to attend visits, though not intention to complete the program, which was moderately to markedly high in both groups. No differences were noted with medication adherence, with high rates of adherence across the entire study sample.ConclusionsOverall, results of the study support the benefits of family engagement in CSC on client participation, though future research is needed to understand why Black families are less engaged and what treatment adaptations are needed to reduce these racial differences. The results also support the value of CSC programs for medication adherence, a critical factor in symptom reduction and mental health recovery.

Measuring Environmental and Behavioral Drivers of Chronic Diseases Using Smartphone-Based Digital Phenotyping: Intensive Longitudinal Observational mHealth Substudy Embedded in 2 Prospective Cohorts of Adults.

Previous studies investigating environmental and behavioral drivers of chronic disease have often had limited temporal and spatial data coverage. Smartphone-based digital phenotyping mitigates the limitations of these studies by using intensive data collection schemes that take advantage of the widespread use of smartphones while allowing for less burdensome data collection and longer follow-up periods. In addition, smartphone apps can be programmed to conduct daily or intraday surveys on health behaviors and psychological well-being. The aim of this study was to investigate the feasibility and scalability of embedding smartphone-based digital phenotyping in large epidemiological cohorts by examining participant adherence to a smartphone-based data collection protocol in 2 ongoing nationwide prospective cohort studies. Participants (N=2394) of the Beiwe Substudy of the Nurses' Health Study 3 and Growing Up Today Study were followed over 1 year. During this time, they completed questionnaires every 10 days delivered via the Beiwe smartphone app covering topics such as emotions, stress and enjoyment, physical activity, access to green spaces, pets, diet (vegetables, meats, beverages, nuts and dairy, and fruits), sleep, and sitting. These questionnaires aimed to measure participants' key health behaviors to combine them with objectively assessed high-resolution GPS and accelerometer data provided by participants during the same period. Between July 2021 and June 2023, we received 11.1 TB of GPS and accelerometer data from 2394 participants and 23,682 survey responses. The average follow-up time for each participant was 214 (SD 148) days. During this period, participants provided an average of 14.8 (SD 5.9) valid hours of GPS data and 13.2 (SD 4.8) valid hours of accelerometer data. Using a 10-hour cutoff, we found that 51.46% (1232/2394) and 53.23% (1274/2394) of participants had >50% of valid data collection days for GPS and accelerometer data, respectively. In addition, each participant submitted an average of 10 (SD 11) surveys during the same period, with a mean response rate of 36% across all surveys (SD 17%; median 41%). After initial processing of GPS and accelerometer data, we also found that participants spent an average of 14.6 (SD 7.5) hours per day at home and 1.6 (SD 1.6) hours per day on trips. We also recorded an average of 1046 (SD 1029) steps per day. In this study, smartphone-based digital phenotyping was used to collect intensive longitudinal data on lifestyle and behavioral factors in 2 well-established prospective cohorts. Our assessment of adherence to smartphone-based data collection protocols over 1 year suggests that adherence in our study was either higher or similar to most previous studies with shorter follow-up periods and smaller sample sizes. Our efforts resulted in a large dataset on health behaviors that can be linked to spatial datasets to examine environmental and behavioral drivers of chronic disease.

Participant Personal Characteristics and Adherence to Oral Capsules: A Secondary Analysis of a Randomized Placebo-Controlled Trial of Antenatal Probiotics.

Adherence to study interventions is critical to the conduct of randomized controlled trials (RCTs). The relationships between participant characteristics and intervention adherence are understudied in pregnant populations. The purpose of this study was to conduct a secondary analysis of adherence to study capsules in a double-masked, placebo-controlled RCT of a probiotic intervention to reduce antenatal Group B Streptococcus colonization, in relationship to participant characteristics. We analyzed the relationship between capsule adherence rates and demographic characteristics among 81 RCT participants. Categorical variables were reported using counts and percentages, and continuous variables were expressed as means along with their standard deviations. For the univariate analyses, we compared demographic variables with adherence scores. A multivariate linear regression model was used to identify predictors of adherence. Average adherence was similar for control and probiotic group participants (P =.86) Univariate analysis showed that average adherence increased directly with age, education, and income. Participants who were partnered or living with others had higher average adherence compared with those who were single and living alone. Asian and White participants had the highest and Black participants had the lowest average, and there was no difference based on Hispanic ethnicity. Adjusting for all the variables in the regression, participants who identified as Black were significantly less likely to adhere to capsules than White participants, and those who were married or living with partners were more likely to adhere than the single participants. Diverse participants are critically important to RCTs. This secondary analysis provides evidence that participant characteristics and the social determinants of health play an important role in adherence to self-administered interventions in RCTs, although more research is needed. Our findings suggest that intentional consideration of RCT participant characteristics may allow for the development and tailoring of strategies to enhance intervention adherence. The study was registered on ClinicalTrials.gov (NCT03696953) on January 10, 2018.

Adoption, Implementation, and Maintenance of Evidence-Based Falls Prevention Programs.

We evaluate the implementation of evidence-based falls prevention programs (EBFPPs) of the Administration for Community Living (ACL) Grantees by (1) describing adoption; (2) evaluating implementation through participant adherence; and (3) describing program maintenance. Secondary data analysis of a national data repository included forty-four ACL grantees spanning 31 states who were funded between September 2014 and December 2019 and provided information on over 80,000 older adult participants. Descriptive statistics including frequencies, percentages, and means were used to describe adoption, implementation (adherence), and maintenance of EBFPPs. Senior centers were the most common organizations to adopt EBFPPs. Most programs were maintained at their respective organizational site through repeat offerings, with several programs (60%) being offered greater than 10 times. Information regarding adoption, implementation, and maintenance of EBFPPs is valuable in identifying the best programs suited for different organizations and their clientele, which can inform policy for scaling and sustaining EBFPPs across the nation.

Treatment fidelity in clinical trials.

In the context of clinical trials, treatment fidelity (TF) has traditionally referred to the extent to which an intervention or treatment is implemented by the clinicians as intended by the researchers who designed the trial. Updated definitions of TF have included an appropriate design of the intervention that was performed in a way that is known to be therapeutically beneficial. This requires careful attention to three key components: (1) protocol and dosage adherence, (2) quality of delivery, and (3) participant adherence. In this viewpoint, we describe several cases in which TF was lacking in clinical trials and give opportunities to improve the deficits encountered in those trials. We feel that along with quality, risk of bias, and certainty of evidence, TF should be considered an essential element of the veracity of clinical trial.

Adverse Events During a 12-month Multi-Site and Dose-Response Aerobic Exercise Intervention.

This study aimed to assess the incidence of adverse events (AE) in older adults participating in a year-long exercise intervention, investigating potential dose-response relationships between exercise intensity and AE frequency, and identifying demographic factors associated with AE risk. A total of 648 older adults were randomized into one of three exercise groups: low-intensity stretching and toning (S&T), 150 minutes of aerobic exercise per week (150Ex), or 225 minutes of aerobic exercise per week (225Ex). Adverse events were tracked during the intervention, with event rates calculated based on participant adherence and time in the study. Generalized linear models were employed to compare AE incidence across groups. Post hoc comparisons were used to calculate incidence rate ratios (IRRs) for AE between groups, adjusting for multiple comparisons. Overall, 306 AE were reported, with 44% related to the intervention. No significant dose-response relationship was observed for all-cause AE between groups. However, intervention-related AE were more frequent in the aerobic exercise groups. Participants in the 150Ex group had a 77% higher rate of intervention-related AE compared to the S&T group, and the 225Ex group had an 88% higher rate. Higher adherence was associated with fewer all-cause AE, and greater comorbid burden was associated with more AE. While aerobic exercise increased the risk of intervention-related AE, the overall risk remained low. Higher adherence to the exercise regimen was associated with fewer AE. These findings suggest aerobic exercise is generally safe in older adults, with the benefits outweighing the risks.

Relevance of therapist feedback in the context of group‑based exercise programs in medical rehabilitation – Results from a qualitative study with patients and exercise therapists

Background Although group-based exercise programs account for nearly half of exercise therapy services provided in German medical rehabilitation facilities, information regarding the application and effects of therapist feedback in this setting is sparse. Therefore, the aim of this qualitative study was to develop an understanding of the relevance of therapist feedback in the context of group-based exercise programs from the patients’ and therapists’ perspective. Methods Semi-structured interviews were conducted with five rehabilitation patients as well as five exercise therapists with work experience in group-based exercise therapy. Data were analysed using structuring content analysis. Results Three types of therapist feedback with respective modalities and characteristics were identified. Besides corrective feedback to support the patients’ exercise instruction, motivational feedback and performance feedback were used to aid the strengthening of psychological resources. Although therapist feedback constituted an important component of patient-therapist-interaction, evidence suggesting a facilitation of coping strategies, participation or long-term physical activity adherence was sparse. Conclusions While therapist feedback in group-based exercise programs likely aids the recovery of physical and psychological functions, its potential to promote the long-term goals of exercise therapy in medical rehabilitation appears to be underutilised.

Value of Engagement in Digital Health Technology Research: Evidence Across 6 Unique Cohort Studies.

Wearable digital health technologies and mobile apps (personal digital health technologies [DHTs]) hold great promise for transforming health research and care. However, engagement in personal DHT research is poor. The objective of this paper is to describe how participant engagement techniques and different study designs affect participant adherence, retention, and overall engagement in research involving personal DHTs. Quantitative and qualitative analysis of engagement factors are reported across 6 unique personal DHT research studies that adopted aspects of a participant-centric design. Study populations included (1) frontline health care workers; (2) a conception, pregnant, and postpartum population; (3) individuals with Crohn disease; (4) individuals with pancreatic cancer; (5) individuals with central nervous system tumors; and (6) families with a Li-Fraumeni syndrome affected member. All included studies involved the use of a study smartphone app that collected both daily and intermittent passive and active tasks, as well as using multiple wearable devices including smartwatches, smart rings, and smart scales. All studies included a variety of participant-centric engagement strategies centered on working with participants as co-designers and regular check-in phone calls to provide support over study participation. Overall retention, probability of staying in the study, and median adherence to study activities are reported. The median proportion of participants retained in the study across the 6 studies was 77.2% (IQR 72.6%-88%). The probability of staying in the study stayed above 80% for all studies during the first month of study participation and stayed above 50% for the entire active study period across all studies. Median adherence to study activities varied by study population. Severely ill cancer populations and postpartum mothers showed the lowest adherence to personal DHT research tasks, largely the result of physical, mental, and situational barriers. Except for the cancer and postpartum populations, median adherences for the Oura smart ring, Garmin, and Apple smartwatches were over 80% and 90%, respectively. Median adherence to the scheduled check-in calls was high across all but one cohort (50%, IQR 20%-75%: low-engagement cohort). Median adherence to study-related activities in this low-engagement cohort was lower than in all other included studies. Participant-centric engagement strategies aid in participant retention and maintain good adherence in some populations. Primary barriers to engagement were participant burden (task fatigue and inconvenience), physical, mental, and situational barriers (unable to complete tasks), and low perceived benefit (lack of understanding of the value of personal DHTs). More population-specific tailoring of personal DHT designs is needed so that these new tools can be perceived as personally valuable to the end user.