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Emotional AdjustmentCARINGNCT04812665

Digital Health for Caregivers Emotional and Self-management Support

An observational study of Emotional Adjustment and Mood Disturbance, run by Adhera Health, Inc. at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Emotional Adjustment, Mood Disturbance
What is being tested?
mHealth solution based on emotional and behavioral change techniques
How many people
65 participants
Where
1 siteSpain
Study dates
17 May 2021to 12 Aug 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario Miguel Servet

    Zaragoza, Aragon, 50009

Other trials in Spain

About this study

Official title: Feasibility Study of Digital Health for Caregivers Emotional and Self-management Support of Children Receiving Growth Hormone Treatment

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).

Read the detailed description

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).

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.
Being tested
mHealth solution based on emotional and behavioral change techniques
Keywords
Emotional Adjustment, Mood Disturbance, Behavioral Intervention, mHealth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mHealth solution based on emotional and behavioral change techniquesBehavioural

    Also called Adhera

    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.

Study groups in NCT04812665
Study groupRoleWhat they receive
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.
Receives: 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).
Receives: Behavioral: mHealth solution based on emotional and behavioral change techniques

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 Month

  2. 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.

    Measured: 3 Months

Secondary outcomes (8)

  1. Emotional outcome: Changes on caregiver's distress

    Distress assessed with the depression, anxiety, and stress scale (DASS-21). DASS-21 is a self-report questionnaire consisting of 21 items, 7 items per subscale: depression, anxiety and stress. Patients are asked to score every item on a scale from 0 (did not apply to me at all) to 3 (applied to me very much). Sum scores are computed by adding up the scores on the items per (sub)scale and multiplying them by a factor 2. Sum scores for the total DASS-total scale thus range between 0 and 120, and those for each of the subscales may range between 0 and 42. Cut-off scores of 60 and 21 are used for the total DASS score and for the subscales respectively. Scores ≥60 (for DASS-total) and ≥21 (for the depression subscale) are labeled as "high" or "severe".

    Measured: 3 Months

  2. Emotional outcome: Changes on caregiver's general wellbeing

    Assessed with the short form of the Mental Health Continuum - short form questionnaire (MHC-SF). Total sum scores on the MHC-SF can range from 0 to 70, with higher scores indicating higher levels of well-being.

    Measured: 3 Months

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

    Perceived self-efficacy assessment with the General Self-Efficacy Scale (GSE), the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.

    Measured: 3 Months

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

    Children HRQoL assessment with KIDSCREEN-10 index answered by the caregiver as a proxy. The scores ranges between 10 and 50, and are linearly converted into 0-100 scale in which higher scores represent better quality of life.

    Measured: 3 Months

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

    Child HRQoL assessment with Quality of Life in Short Statured Youth (QoLISSY) questionnaire answered by the caregiver as a proxy. This version has 47 items with a 5-point likert scale each. Total score is linearly transformed into 0 to 100 scores with higher values representing higher HRQOL.

    Measured: 3 Months

  6. Behavioral outcome: Usability

    mHealth solution usability assessed with the System Usability Scale (SUS) questionnaire. SUS can range between 0 and 100 scores, with higher values representing higher usability.

    Measured: 3 Months

  7. Behavioral outcome: Treatment adherence

    Adherence to the Growth Hormone treatment (GHt) will be measured with the data collected by the Easypod Connect device.

    Measured: 3 Months

  8. Growth parameter: height

    Height is a crucial indicator of the growth of children under Growth Hormone therapy. Measures from 6 month before starting the study to the end of the study will be obtained from Patient's Electronic Health Record.

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2021
  2. Study start17 May 2021
  3. Primary completion12 Aug 2022
  4. Study completion12 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04812665
Sponsor's protocol ID
CAR-0220
Acronym
CARING
Status last verified
Mar 2023
First submitted
17 Mar 2021
Last updated
29 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32338624

  • 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.

    PubMed 30413176

  • 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.

    PubMed 7726811

  • 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.

    PubMed 24905070

  • 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.

    PubMed 3397865

  • 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.

    PubMed 15653244

  • 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.

    PubMed 39908086

  • 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.

    PubMed 35964116

  • 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.

    PubMed 35062149

Questions about this trial

What is this clinical trial studying?

An observational study of Emotional Adjustment and Mood Disturbance, run by Adhera Health, Inc. at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sub-study 1: Psychological burdens experienced as caregivers of children receiving GHt and barriers/facilitators for adopting the mHealth solution (time frame: 1 Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04812665, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.

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