NCT06520787已完成不适用
DAta-driven personaLIzation of a digitAl Health Solution to Support Family Caregivers of Children With Chronic Conditions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Treatment satisfaction
研究概览
简要总结
The goal of this feasibility study is to explore the needs of families with children with obesity and evaluate the impact of a combined intervention (children with obesity receiving pharmacological therapy in combination with the Adhera Caring Digital Program®) on treatment satisfaction, adherence, and mood. The main objectives are:
- To evaluate the impact of the treatment combination (ACDP® and pharmacological treatment) in terms of satisfaction, engagement, adherence and mood, in families with children with obesity.
- To better understand the educational and support needs of the families of children with obesity while under treatment and lifestyle changes.
Participants will:
- Use the Adhera Caring Digital Program® (ACDP®) for obesity, which includes digital therapeutic software, personalized messages, and educational materials.
- Take pharmacological treatment as prescribed for one year.
- Wear activity wristbands/watches to collect biometric data.
- Attend monthly clinic visits for assessments and monitoring.
- Complete psychometric questionnaires to measure satisfaction, adherence, and emotional outcomes.
- Engage in chat-based communication and video conferencing with health coaches for support and monitoring.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caregivers of children between 13 and 18 years who are diagnosed with obesity and undergoing treatment according to the approved label by AEMPS1 (adolescents with obesity aged 12 years and older with an initial BMI at the 95th percentile or greater for age and sex).
- •Families of children with obesity who have been under pharmacological treatment before screening. This includes treatment with any of the following medications orlistat, metformin, liraglutide, semaglutide.
- •Participants who are willing to join ACDP® for 10 months and can interact with a smartphone during that time.
- •The family is willing to complement the pharmacological obesity treatment with a digital intervention.
- •Participants (patients and their caregivers) must be willing to use wearables for the entire length of the study.
- •Parents previously using a wearable will agree not to use it during the length of the study, as their wearable account must be synched to the patient's device. Further, they may need to agree on changing the account data for height, weight, and gender in their Google account.
排除标准
- •Families not fluent in Spanish.
- •Families of children with obesity and comorbidities.
- •Families of children with secondary causes of obesity (i.e., hypothalamic, genetic or endocrine causes).
结局指标
主要结局
Treatment satisfaction
时间窗: Day 1 to Day 365
Treatment satisfaction measured by Treatment Expectation Scale/Treatment Satisfacyion Scale. Minimum Value: 0. Maximum Value: 10. Interpretation: Higher scores indicate better outcomes (greater treatment expectation/satisfaction).
Treatment adherence 1
时间窗: Day 1 to Day 365
Treatment adherence measured by injection (self-reported). Unit of measure: Number of injections (quantitative data)
Treatment adherence 2
时间窗: Day 1 to Day 365
Treatment adherence measured by changes in nutritional compliance (self-reported). Unit of measure: Description of diet (qualitative data).
Treatment adherence 3
时间窗: Day 150 to Day 365
Treatment adherence measured by discontinuation (and reasons behind it). Unit of measure: Incidence of discontinuation with categorized reasons.
次要结局
- Heart rate(Baseline (Day 1) to Day 300)
- 6-minute walk test performance(Baseline (Day 1) to Day 365)
- Health-related Quality of Life (HrQoL)(Baseline (Day 1) to Day 365)
- Levels of physical activity(Baseline (Day 1) to Day 365)
- Height(Baseline (Day 1) to Day 365)
- Weight(Baseline (Day 1) to Day 365)
- Body Mass Index (BMI)(Baseline (Day 1) to Day 365)
- Emotional outcome 1(Baseline (Day 1) to Day 365)
- Time since diagnosis(Baseline (Day 1) to Day 365)
- Previous obesity treatments(Baseline (Day 1) to Day 365)
- Emotional outcome 2(Baseline (Day 1) to Day 365)
- Cholesterol levels(Baseline (Day 1) to Day 365)
- Emotional outcome 3(Baseline (Day 1) to Day 365)
- Complications(Baseline (Day 1) to Day 365)
- Step count(Baseline (Day 1) to Day 396)
- Physical activity levels(Baseline (Day 1) to Day 300)
- Sleep quality(Baseline (Day 1) to Day 300)
- Emotional outcome 1(Baseline (Day 1) to Day 365)
- Emotional outcome 2(Baseline (Day 1) to Day 365)
- Emotional outcome 3(Baseline (Day 1) to Day 365)
- Health-related Quality of Life (HrQoL)(Baseline (Day 1) to Day 365)
- Levels of physical activity(Baseline (Day 1) to Day 365)
- Height(Baseline (Day 1) to Day 365)
- Weight(Baseline (Day 1) to Day 365)
- Body Mass Index (BMI)(Baseline (Day 1) to Day 365)
- Blood pressure(Baseline (Day 1) to Day 365)
- Time since diagnosis(Baseline (Day 1) to Day 365)
- Previous obesity treatments(Baseline (Day 1) to Day 365)
- Cholesterol levels(Baseline (Day 1) to Day 365)
- Complications(Baseline (Day 1) to Day 365)
- Step count(Baseline (Day 1) to Day 396)
- Physical activity levels(Baseline (Day 1) to Day 300)
- Sleep quality(Baseline (Day 1) to Day 300)
- Heart rate(Baseline (Day 1) to Day 300)
- 6-minute walk test performance(Baseline (Day 1) to Day 365)
- System Usability(Day 150 to 300)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Family-centred E-health in Pediatric Weight Management: A Pilot StudyPediatric ObesityNCT01912183McMaster University60
已完成
不适用
Healthy Juntos Pilot StudyActivity, MotorDiet, HealthySedentary BehaviorObesityNCT03986190University of Miami100
已完成
不适用
dHealth Solution for Improving Parent Adherence to Behavioral Treatment for ADHDAttention Deficit Hyperactivity DisorderNCT04025814University of California, San Francisco73
进行中（未招募）
不适用
Evaluation of Health and Lifestyle ToolDiabetes Mellitus, Type 2NCT04691973Region Skane300
已完成
不适用
Promoting Intergenerational Health in Rural Kentuckians With Diabetes (PIHRK'D)Diabetes Mellitus, Type 2NCT06080425The University of Texas Medical Branch, Galveston48