Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06520787
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-04
Brief Title:
DAta-driven personaLIzation of a digitAl Health Solution to Support Family Caregivers of Children With Chronic Conditions
Sponsor:
None
Organization:
None
Study Overview
Official Title:
DAta-driven personaLIzation of a digitAl Health Solution to Support Family Caregivers of Children With Chronic Conditions
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DALIA
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 Semaglutide in combination with the Adhera Caring Digital Program on treatment satisfaction adherence and mood The main questions it aims to answer are
Does the combination of Semaglutide and the Adhera Caring Digital Program improve treatment satisfaction adherence and mood in families of children with obesity compared to the standard of care
What are the emotional and health-related quality of life outcomes for children and their families using the combined treatment versus the standard of care
Researchers will compare the intervention group using the Adhera Caring Digital Program with Semaglutide to the control group standard of care without digital or pharmacological intervention to see if there is a significant difference in the primary and secondary outcomes
Participants will
Use the Adhera Caring Digital Program ACDP for obesity which includes digital therapeutic software personalized messages and educational materials
Take Semaglutide as prescribed for one year
Wear activity wristbandswatches 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
Does the combination of Semaglutide and the Adhera Caring Digital Program improve treatment satisfaction adherence and mood in families of children with obesity compared to the standard of care
What are the emotional and health-related quality of life outcomes for children and their families using the combined treatment versus the standard of care
Researchers will compare the intervention group using the Adhera Caring Digital Program with Semaglutide to the control group standard of care without digital or pharmacological intervention to see if there is a significant difference in the primary and secondary outcomes
Participants will
Use the Adhera Caring Digital Program ACDP for obesity which includes digital therapeutic software personalized messages and educational materials
Take Semaglutide as prescribed for one year
Wear activity wristbandswatches 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None