The Atrial Fibrillation Health Literacy Information Technology Trial: Pilot Trial of a Mobile Health App for Atrial Fibrillation

Background Atrial fibrillation (AF) is a common arrhythmia that adversely affects health-related quality of life (HRQoL). We conducted a pilot trial of individuals with AF using a smartphone to provide a relational agent as well as rhythm monitoring. We employed our pilot to measure acceptability and adherence and to assess its effectiveness in improving HRQoL and adherence. Objective This study aims to measure acceptability and adherence and to assess its effectiveness to improve HRQoL and adherence. Methods Participants were recruited from ambulatory clinics and randomized to a 30-day intervention or usual care. We collected baseline characteristics and conducted baseline and 30-day assessments of HRQoL using the Atrial Fibrillation Effect on Quality of Life (AFEQT) measure and self-reported adherence to anticoagulation. The intervention consisted of a smartphone-based relational agent, which simulates face-to-face counseling and delivered content on AF education, adherence, and symptom monitoring with prompted rhythm monitoring. We compared differences in AFEQT and adherence at 30 days, adjusted for baseline values. We quantified participants’ use and acceptability of the intervention. Results A total of 120 participants were recruited and randomized (59 to control and 61 to intervention) to the pilot trial (mean age 72.1 years, SD 9.10; 62/120, 51.7% women). The control group had a 95% follow-up, and the intervention group had a 93% follow-up. The intervention group demonstrated significantly higher improvement in total AFEQT scores (adjusted mean difference 4.5; 95% CI 0.6-8.3; P=.03) and in daily activity (adjusted mean difference 7.1; 95% CI 1.8-12.4; P=.009) compared with the control between baseline and 30 days. The intervention group showed significantly improved self-reported adherence to anticoagulation therapy at 30 days (intervention 3.5%; control 23.2%; adjusted difference 16.6%; 95% CI 2.8%-30.4%; P<.001). Qualitative assessments of acceptability identified that participants found the relational agent useful, informative, and trustworthy. Conclusions Individuals randomized to a 30-day smartphone intervention with a relational agent and rhythm monitoring showed significant improvement in HRQoL and adherence. Participants had favorable acceptability of the intervention with both objective use and qualitative assessments of acceptability.

Covert administration of medication in food: a worthwhile moral gamble?

The covert administration of medication occurs with incapacitated patients without their knowledge, involving some form of deliberate deception in disguising or hiding the medication. Covert medication in food is a relatively common practice globally, including in institutional and homecare contexts. Until recently, it has received little attention in the bioethics literature, and there are few laws or rules governing the practice. In this paper, we discuss significant, but often overlooked, ethical issues related to covert medication in food. We emphasise the variety of ways in which eating has ethical importance, highlighting what is at risk if covert administration of medication in food is discovered. For example, losing trust in feeders and food due to covert medication may risk important opportunities for identity maintenance in contexts where identity is already unstable. Since therapeutic relationships may be jeopardised by a patient’s discovery that caregivers had secretly put medications in their food, this practice can result in an ongoing deception loop. While there may be circumstances in which covert medication is ethically justified, given a lack of suitable alternatives, we argue that in any particular case this practice should be continually re-evaluated in light of the building moral costs to the relational agent over time.

The Atrial Fibrillation Health Literacy Information Technology Trial: Pilot Trial of a Mobile Health App for Atrial Fibrillation (Preprint)

BACKGROUND Atrial fibrillation (AF) is a common arrhythmia that adversely affects health-related quality of life (HRQoL). We conducted a pilot trial of individuals with AF using a smartphone to provide a relational agent as well as rhythm monitoring. We employed our pilot to measure acceptability and adherence and to assess its effectiveness in improving HRQoL and adherence. OBJECTIVE This study aims to measure acceptability and adherence and to assess its effectiveness to improve HRQoL and adherence. METHODS Participants were recruited from ambulatory clinics and randomized to a 30-day intervention or usual care. We collected baseline characteristics and conducted baseline and 30-day assessments of HRQoL using the Atrial Fibrillation Effect on Quality of Life (AFEQT) measure and self-reported adherence to anticoagulation. The intervention consisted of a smartphone-based relational agent, which simulates face-to-face counseling and delivered content on AF education, adherence, and symptom monitoring with prompted rhythm monitoring. We compared differences in AFEQT and adherence at 30 days, adjusted for baseline values. We quantified participants’ use and acceptability of the intervention. RESULTS A total of 120 participants were recruited and randomized (59 to control and 61 to intervention) to the pilot trial (mean age 72.1 years, SD 9.10; 62/120, 51.7% women). The control group had a 95% follow-up, and the intervention group had a 93% follow-up. The intervention group demonstrated significantly higher improvement in total AFEQT scores (adjusted mean difference 4.5; 95% CI 0.6-8.3; <i>P</i>=.03) and in daily activity (adjusted mean difference 7.1; 95% CI 1.8-12.4; <i>P</i>=.009) compared with the control between baseline and 30 days. The intervention group showed significantly improved self-reported adherence to anticoagulation therapy at 30 days (intervention 3.5%; control 23.2%; adjusted difference 16.6%; 95% CI 2.8%-30.4%; <i>P</i>&lt;.001). Qualitative assessments of acceptability identified that participants found the relational agent useful, informative, and trustworthy. CONCLUSIONS Individuals randomized to a 30-day smartphone intervention with a relational agent and rhythm monitoring showed significant improvement in HRQoL and adherence. Participants had favorable acceptability of the intervention with both objective use and qualitative assessments of acceptability.

Using Relational Agents to Promote Family Communication Around Type 1 Diabetes Self-Management in the Diabetes Family Teamwork Online Intervention: Longitudinal Pilot Study

Background Family conflict can reduce adolescent adherence to type 1 diabetes management tasks. The Family Teamwork in-person intervention was shown to be efficacious in reducing conflict and low adherence to diabetes-related tasks. Its reach and potential impact, however, were limited by the need to deliver the intervention sessions in person. Relational agents (ie, computerized versions of humans) have been shown to appeal to diverse audiences and may be an acceptable replacement for a human in technology-based behavior change interventions. Objective The purpose of this paper is to present the results of a pilot study assessing feasibility and acceptability of Diabetes Family Teamwork Online, an adapted version of the Family Teamwork intervention, delivered over the internet and guided by a relational agent. Methods Parent-adolescent dyads were recruited through a diabetes care clinic at a large tertiary care hospital in the southwestern United States. A one-group design, with assessments at baseline, immediate postintervention, and 3 months later, was used to assess feasibility. A priori feasibility criteria included an assessment of recruitment, completion, attrition, program satisfaction, therapeutic alliance, attitudes toward the relational agent, and data collection. The institutional review board at Baylor College of Medicine approved the protocol (H-37245). Results Twenty-seven adolescents aged 10 to 15 years with type 1 diabetes and their parents were enrolled. Criteria used to assess feasibility were (1) recruitment goals were met (n=20), (2) families completed ≥75% of the modules, (3) attrition rate was ≤10%, (4) program satisfaction was high (≥80% of families), (5) therapeutic alliance was high (average score of ≥60/84), (6) families expressed positive attitudes toward the relational agent (average item score of ≥5 on ≥4 items), (7) ≥80% of data were collected at post 1 and post 2, and (8) few technical issues (≤10%) occurred during intervention delivery. All feasibility criteria were met. Qualitative data confirmed that adolescents and parents had positive reactions to both the content and approach. Conclusions The Diabetes Family Teamwork Online intervention proved to be a feasible and acceptable method for enhancing communication around diabetes management tasks in families with an adolescent who has type 1 diabetes. International Registered Report Identifier (IRRID) RR2-10.2196/resprot.5817

Using Relational Agents to Promote Family Communication Around Type 1 Diabetes Self-Management in the Diabetes Family Teamwork Online Intervention: Longitudinal Pilot Study (Preprint)

BACKGROUND Family conflict can reduce adolescent adherence to type 1 diabetes management tasks. The Family Teamwork in-person intervention was shown to be efficacious in reducing conflict and low adherence to diabetes-related tasks. Its reach and potential impact, however, were limited by the need to deliver the intervention sessions in person. Relational agents (ie, computerized versions of humans) have been shown to appeal to diverse audiences and may be an acceptable replacement for a human in technology-based behavior change interventions. OBJECTIVE The purpose of this paper is to present the results of a pilot study assessing feasibility and acceptability of Diabetes Family Teamwork Online, an adapted version of the Family Teamwork intervention, delivered over the internet and guided by a relational agent. METHODS Parent-adolescent dyads were recruited through a diabetes care clinic at a large tertiary care hospital in the southwestern United States. A one-group design, with assessments at baseline, immediate postintervention, and 3 months later, was used to assess feasibility. A priori feasibility criteria included an assessment of recruitment, completion, attrition, program satisfaction, therapeutic alliance, attitudes toward the relational agent, and data collection. The institutional review board at Baylor College of Medicine approved the protocol (H-37245). RESULTS Twenty-seven adolescents aged 10 to 15 years with type 1 diabetes and their parents were enrolled. Criteria used to assess feasibility were (1) recruitment goals were met (n=20), (2) families completed ≥75% of the modules, (3) attrition rate was ≤10%, (4) program satisfaction was high (≥80% of families), (5) therapeutic alliance was high (average score of ≥60/84), (6) families expressed positive attitudes toward the relational agent (average item score of ≥5 on ≥4 items), (7) ≥80% of data were collected at post 1 and post 2, and (8) few technical issues (≤10%) occurred during intervention delivery. All feasibility criteria were met. Qualitative data confirmed that adolescents and parents had positive reactions to both the content and approach. CONCLUSIONS The Diabetes Family Teamwork Online intervention proved to be a feasible and acceptable method for enhancing communication around diabetes management tasks in families with an adolescent who has type 1 diabetes. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) RR2-10.2196/resprot.5817