DAta-driven personaLIzation of a digitAl Health Solution to Support Family Caregivers of Children With Chronic Conditions

N/ARecruitingNCT06520787

Adhera Health, Inc.40 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Obesity, Childhood

Interventions

ACDP® and pharmacological treatment for obesity

40 Families of children with obesity that are already undergoing treatment and are willing to join a combined intervention. After the recruitment, the family will join Adhera Caring Digital Program® for 10 months. The combined intervention (digital and pharmacological intervention) will last one year, and there will be a 2-month follow-up. During the whole study (12 months, from recruiting to the end of follow-up) participants will wear a smartwatch (Fitbit or similar).

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: * 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. Exclusion criteria: * 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).

Locations (1)

Hospital Universitario Miguel Servet

Zaragoza, Aragon, Spain

RECRUITING

Outcomes

Primary Outcomes

Treatment satisfaction

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).

Time frame: Day 1 to Day 365

Treatment adherence 1

Treatment adherence measured by injection (self-reported). Unit of measure: Number of injections (quantitative data)

Time frame: Day 1 to Day 365

Treatment adherence 2

Treatment adherence measured by changes in nutritional compliance (self-reported). Unit of measure: Description of diet (qualitative data).

Time frame: Day 1 to Day 365

Treatment adherence 3

Treatment adherence measured by discontinuation (and reasons behind it). Unit of measure: Incidence of discontinuation with categorized reasons.

Time frame: Day 150 to Day 365

Secondary Outcomes

Emotional outcome 1

These tend to be sensitive to change in short-term and will include distress assessed by the Depression Anxiety and Stress Scale (DASS-21) and the distress thermometer. Minimum Value: 0. Maximum Value: 63. Interpretation: Higher scores indicate worse outcomes (greater levels of depression, anxiety, and stress).

Time frame: Baseline (Day 1) to Day 365

Emotional outcome 2

These tend to be sensitive to change in short-term and will include Weight Self-Stigma Questionnaire (S-WSSQ). Minimum Value: 12. Maximum Value: 60. Interpretation: Higher scores indicate worse outcomes (greater self-stigma related to weight).

Time frame: Baseline (Day 1) to Day 365

Emotional outcome 3

These tend to be sensitive to change in short-term and will include perceived self-efficacy assessment by the General Self-Efficacy Scale (GSE). Minimum Value: 10. Maximum Value: 40. Interpretation: Higher scores indicate better outcomes (greater self-efficacy).

Time frame: Baseline (Day 1) to Day 365

Health-related Quality of Life (HrQoL)

Quality of life tends to change over longer periods of time, and often do require follow-ups of 6 months or one year. However, some dimensions (e.g. mental) are estimated to change faster in shorter periods. HrQoL will be assessed with regard to the children by the caregivers' perspective from the KIDSCREEN-10. Minimum Value: 10. Maximum Value: 50. Interpretation: Higher scores indicate better outcomes (better health-related quality of life).

Time frame: Baseline (Day 1) to Day 365

Levels of physical activity

Life-style questionnaires on Levels of physical activity (APALQ; Assessment of Physical Activity Levels Questionnaire ). Minimum Value: Varies based on questionnaire design. Maximum Value: Varies based on questionnaire design. Interpretation: Higher scores generally indicate better outcomes (higher levels of physical activity).

Time frame: Baseline (Day 1) to Day 365

Height

From bioimpedance scale. Standard medical measurement. Unit of measure: meters.

Time frame: Baseline (Day 1) to Day 365

Weight

From bioimpedance scale. Standard medical measurement. Unit of measure: kilograms.

Time frame: Baseline (Day 1) to Day 365

Body Mass Index (BMI)

From bioimpedance scale. Calculated from height and weight. Unit of measure: kg/m²

Time frame: Baseline (Day 1) to Day 365

Blood pressure

Standard pressure measurement. Unit of measure: mmHg.

Time frame: Baseline (Day 1) to Day 365

Time since diagnosis

From patient medical records or self-reported data. Unit of measure: weeks, months or years.

Time frame: Baseline (Day 1) to Day 365

Previous obesity treatments

From patient medical records and self-reported data. Unit of measure: Description of treatment (qualitative data).

Time frame: Baseline (Day 1) to Day 365

Cholesterol levels

Blood test results. Unit of measure: mg/dL

Time frame: Baseline (Day 1) to Day 365

Complications

From patient medical records or self-reported. Unit of measure: Incidence and type of complications (qualitative data)

Time frame: Baseline (Day 1) to Day 365

Step count

From wearable device. Unit of measure: number of steps per day.

Time frame: Baseline (Day 1) to Day 396

Physical activity levels

From wearable device. Unit of measure: minutes of moderate to vigorous activity per day.

Time frame: Baseline (Day 1) to Day 300

Sleep quality

From wearable device. Unit of measure: Sleep score or duration and quality of sleep (hours and sleep stages).

Time frame: Baseline (Day 1) to Day 300

Heart rate

From wearable device. Unit of measure: average resting heart rate (beats per minute).

Time frame: Baseline (Day 1) to Day 300

6-minute walk test performance

Standardized 6-minute walk test. Unit of measure: distance covered in meters.

Time frame: Baseline (Day 1) to Day 365

System Usability

Measures the perceived usability of ACDP. Minimum Value: 0. Maximum Value: 10. Interpretation: Higher scores indicate better perceibed usability

Time frame: Day 150 to 300

Central Contacts

Luis Fernadez-Luque, Dr

CONTACT

+34 656930901 luis@adherahealth.com

Data from ClinicalTrials.gov

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