CompletedNot Applicable

Digital Health for Caregivers Emotional and Self-management Support

Spain65 participantsStarted 2021-05-17

Plain-language summary

This feasibility study builds upon mental health and technology acceptance theoretical frameworks. It seeks to examine potentials of a novel mobile Health (mHealth) solution based on emotional and behavioral change techniques, to provide emotional and self-management tailored support to caregivers of children undergoing Growth Hormone treatment (GHt).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

The study targets caregivers of GHt patients. Inclusion Criteria: * Adherence to GHt monitored in the last month prior enrollment indicates a ratio less than 85%. * Legal guardian of children who receive GHt in accordance with approved indications in Spain. * Explicit agreement on data sharing regarding adherence to GHt gathered through the Easypod Connect. * Participants must be able to interact with a smart phone and willing to install the mHealth solution of the study in their smart phone. * Participants must sign the specific informed consent form for the study. Exclusion Criteria: * Candidates without an smart phone or not being able to interact with it. * Only one legal guardian per child can participate in the study. * Participants of SS1 will not take part in SS2.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sub-study 1: Psychological burdens experienced as caregivers of children receiving GHt and barriers/facilitators for adopting the mHealth solution

Timeframe: 1 Month

Sub-study 2: Changes on caregiver's positive mood

Timeframe: 3 Months

Trial details

NCT IDNCT04812665

SponsorAdhera Health, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-08-12

View on ClinicalTrials.gov More Emotional Adjustment trials