Digital Health for Caregivers Emotional and Self-management Support

NCT04812665 | Completed

• 1 other identifier: CAR-0220
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Emotional Adjustment; Mood Disturbance

Keywords

Emotional Adjustment; Mood Disturbance; Behavioral Intervention; mHealth

Outcome Measures

Primary Outcomes (2)

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

  A semi-structured interview based on a mental health and technology acceptance theoretical framework has been specifically designed for this purpose

  1 Month

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

  Positive subscale of the Positive and Negative Affect Scale (PANAS). Scores can range from 10-50 for both the Positive and Negative Affect with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect.

  3 Months

Secondary Outcomes (8)

• Emotional outcome: Changes on caregiver's distress

  3 Months

• Emotional outcome: Changes on caregiver's general wellbeing

  3 Months

• Emotional outcome: Changes on caregiver's perceived self-efficacy

  3 Months

• Health-related Quality of Life (HrQoL): Changes on child's HRQoL

  3 Months

• Health-related Quality of Life (HrQoL): Changes on child's HRQoL

  3 Months

Study Arms (2)

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.

Behavioral: mHealth solution based on emotional and behavioral change techniques

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).

Behavioral: mHealth solution based on emotional and behavioral change techniques

Interventions

mHealth solution based on emotional and behavioral change techniques BEHAVIORAL

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.

Also known as: Adhera

Qualitative sub-study (SS1); Quantitative sub-study (SS2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 healthcare delivery to the regional area of Zaragoza (Spain), which covers a total of 367.110 inhabitants. Participants will sign an informed consent during routine clinical visits to the centers. For accessing treatment adherence data (Easypod-Connect) of children aged 12 y.o. and over, a specific Informed Consent Form (ICF) will also need to be signed by the minor according to the Spanish regulation, jointly with the legal guardian's one.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adhera Health, Inc.: lead
• Hospital Miguel Servet: collaborator
• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (1)

Hospital Universitario Miguel Servet

Zaragoza, Aragon, 50009, Spain

Location

Related Publications (9)

• 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.

  PMID: 32338624 BACKGROUND

• 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.

  PMID: 30413176 BACKGROUND

• 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.

  PMID: 7726811 BACKGROUND

• 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.

  PMID: 24905070 BACKGROUND

• 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.

  PMID: 3397865 BACKGROUND

• 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.

  PMID: 15653244 BACKGROUND

• 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.

  PMID: 39908086 DERIVED

• 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.

  PMID: 35964116 DERIVED

• 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.

  PMID: 35062149 DERIVED

Study Officials

• Luis Fernández-Luque, PhD

  Adhera Health, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 24, 2021
• Study Start: May 17, 2021
• Primary Completion: August 12, 2022
• Study Completion: August 12, 2022
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)