Digital Health for Caregivers Emotional and Self-management Support
NCT ID: NCT04812665
Last Updated: 2023-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
65 participants
OBSERVATIONAL
2021-05-17
2022-08-12
Brief Summary
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Detailed Description
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Primary Objectives:
* To gather qualitative information enabling to better understand individualized experiences of caregiving children undergoing GHt and perceived barriers/facilitators for adoption of the mHealth solution.
* To assess positive mood states of caregivers of GHt patients as an indicator of emotional wellbeing related to the use of the mHealth solution.
Secondary Objectives:
To explore whether the mHealth solution applied to caregivers of children undergoing GHt might affect:
* Broader emotion-related parameters: Distress (emotional disturbance), self-efficacy (perceived own capability of managing stress), and general psychological wellbeing of caregivers.
* Perceived Health-related quality of life (HRQoL) of children (evaluated from the caregivers' perspective).
* Behavioral parameters: Usability / engagement with the mHealth solution and children's adherence to treatment measured by Easypod-Connect.
* Growth parameters: height of the child.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Qualitative sub-study (SS1)
One group of caregivers (n = 10) will engage with the mHealth solution during 1 month. Subsequently, an individual semi-structured interview with each of the participants will proceed to gather user experience qualitative information.
mHealth solution based on emotional and behavioral change techniques
Adhera supports the empowerment of patients with chronic conditions by supporting the acquisition of healthier lifestyles, improved mental wellbeing and grounded on the principles of behavioral change.
The solution is based on incorporating the principles of personalized health education into a mobile platform which is achieved by applying the Integrated Model of Behavioral Change which is further adapted using recommender systems. Emotional and mental health elements, such as stress, resilience, are crucial part in the acquisition of self-management behaviors and will be the main focus of this intervention. Adhera adapts to provide tailored support to specific users' needs.
Quantitative sub-study (SS2)
A different group of caregivers (n = 55) will engage with the mHealth solution during 3 months. As elaborated in the following sections, a quantitative approach will be adopted to assess different emotional, behavioral and growth parameters before and after engaging with the mHealth solution (pre-post design).
mHealth solution based on emotional and behavioral change techniques
Adhera supports the empowerment of patients with chronic conditions by supporting the acquisition of healthier lifestyles, improved mental wellbeing and grounded on the principles of behavioral change.
The solution is based on incorporating the principles of personalized health education into a mobile platform which is achieved by applying the Integrated Model of Behavioral Change which is further adapted using recommender systems. Emotional and mental health elements, such as stress, resilience, are crucial part in the acquisition of self-management behaviors and will be the main focus of this intervention. Adhera adapts to provide tailored support to specific users' needs.
Interventions
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mHealth solution based on emotional and behavioral change techniques
Adhera supports the empowerment of patients with chronic conditions by supporting the acquisition of healthier lifestyles, improved mental wellbeing and grounded on the principles of behavioral change.
The solution is based on incorporating the principles of personalized health education into a mobile platform which is achieved by applying the Integrated Model of Behavioral Change which is further adapted using recommender systems. Emotional and mental health elements, such as stress, resilience, are crucial part in the acquisition of self-management behaviors and will be the main focus of this intervention. Adhera adapts to provide tailored support to specific users' needs.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Only one legal guardian per child can participate in the study.
* Participants of SS1 will not take part in SS2.
18 Years
ALL
Yes
Sponsors
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Hospital Miguel Servet
OTHER
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
INDUSTRY
Adhera Health, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Luis Fernández-Luque, PhD
Role: PRINCIPAL_INVESTIGATOR
Adhera Health, Inc.
Locations
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Hospital Universitario Miguel Servet
Zaragoza, Aragon, Spain
Countries
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References
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Carrasco-Hernandez L, Jodar-Sanchez F, Nunez-Benjumea F, Moreno Conde J, Mesa Gonzalez M, Civit-Balcells A, Hors-Fraile S, Parra-Calderon CL, Bamidis PD, Ortega-Ruiz F. A Mobile Health Solution Complementing Psychopharmacology-Supported Smoking Cessation: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Apr 27;8(4):e17530. doi: 10.2196/17530.
Hors-Fraile S, Malwade S, Spachos D, Fernandez-Luque L, Su CT, Jeng WL, Syed-Abdul S, Bamidis P, Li YJ. A recommender system to quit smoking with mobile motivational messages: study protocol for a randomized controlled trial. Trials. 2018 Nov 9;19(1):618. doi: 10.1186/s13063-018-3000-1.
Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
Mohr DC, Schueller SM, Montague E, Burns MN, Rashidi P. The behavioral intervention technology model: an integrated conceptual and technological framework for eHealth and mHealth interventions. J Med Internet Res. 2014 Jun 5;16(6):e146. doi: 10.2196/jmir.3077.
Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
Vries Hd, Mesters I, van de Steeg H, Honing C. The general public's information needs and perceptions regarding hereditary cancer: an application of the Integrated Change Model. Patient Educ Couns. 2005 Feb;56(2):154-65. doi: 10.1016/j.pec.2004.01.002.
Jimenez-Diaz A, Pierantonelli M, Morte Coscolin P, Salinas-Uhalte A, Quer-Palomas S, Rivera-Romero O, Herrero R, Fernandez-Luque L, Banos R, Berrios RC, de Arriba A. Digital Health Program to Support Family Caregivers of Children Undergoing Growth Hormone Therapy: Qualitative Feasibility Study. JMIR Pediatr Parent. 2025 Feb 5;8:e55023. doi: 10.2196/55023.
Cervera-Torres S, Nunez-Benjumea FJ, de Arriba Munoz A, Chicchi Giglioli IA, Fernandez-Luque L. Digital health for emotional and self-management support of caregivers of children receiving growth hormone treatment: a feasibility study protocol. BMC Med Inform Decis Mak. 2022 Aug 13;22(1):215. doi: 10.1186/s12911-022-01935-1.
Nunez-Benjumea FJ, Munoz AA, Callau MV, Fernandez-Luque L. Description of a Digital Health Platform for Emotional and Self-Management Support of Caregivers of Children Receiving Growth Hormone Treatment. Stud Health Technol Inform. 2022 Jan 14;289:290-292. doi: 10.3233/SHTI210916.
Other Identifiers
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CAR-0220
Identifier Type: -
Identifier Source: org_study_id
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