Clinical trial NCT06520787: DAta-driven personaLIzation of a digitAl Health Solution to Support Family Caregivers of Children With Chronic Conditions
Official title: DAta-driven personaLIzation of a digitAl Health Solution to Support Family Caregivers of Children With Chronic Conditions
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obesity, Childhood
Keywords: Obesity
Digital health
Treatment satisfaction
pharmacological treatment for obesity
Lead sponsor: Adhera Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hospital Universitario Miguel Servet, Zaragoza
name: University of Valencia
name: University of Seville
First posted: 2024-07-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The sample of the study (caregivers) will be recruited from the Pediatric Endocrinology unit at the Miguel Servet Children's University Hospital. This public hospital provides pediatric health attention to the regional area of Zaragoza (Spain), which covers a total of 367.110 inhabitants.

Families of children with obesity that are already undergoing treatment and are willing to join a combined intervention.

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Treatment satisfaction
timeFrame: Day 1 to Day 365
measure: Treatment adherence 1
timeFrame: Day 1 to Day 365
measure: Treatment adherence 2
timeFrame: Day 1 to Day 365
measure: Treatment adherence 3
timeFrame: Day 150 to Day 365
Secondary outcomes:
measure: Emotional outcome 1
timeFrame: Baseline (Day 1) to Day 365
measure: Emotional outcome 2
timeFrame: Baseline (Day 1) to Day 365
measure: Emotional outcome 3
timeFrame: Baseline (Day 1) to Day 365
measure: Health-related Quality of Life (HrQoL)
timeFrame: Baseline (Day 1) to Day 365
measure: Levels of physical activity
timeFrame: Baseline (Day 1) to Day 365
measure: Height
timeFrame: Baseline (Day 1) to Day 365
measure: Weight
timeFrame: Baseline (Day 1) to Day 365
measure: Body Mass Index (BMI)
timeFrame: Baseline (Day 1) to Day 365
measure: Blood pressure
timeFrame: Baseline (Day 1) to Day 365
measure: Time since diagnosis
timeFrame: Baseline (Day 1) to Day 365
measure: Previous obesity treatments
timeFrame: Baseline (Day 1) to Day 365
measure: Cholesterol levels
timeFrame: Baseline (Day 1) to Day 365
measure: Complications
timeFrame: Baseline (Day 1) to Day 365
measure: Step count
timeFrame: Baseline (Day 1) to Day 396
measure: Physical activity levels
timeFrame: Baseline (Day 1) to Day 300
measure: Sleep quality
timeFrame: Baseline (Day 1) to Day 300
measure: Heart rate
timeFrame: Baseline (Day 1) to Day 300
measure: 6-minute walk test performance
timeFrame: Baseline (Day 1) to Day 365
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
state: Aragón
Study officials:
References: