Digital Health for Caregivers Emotional and Self-management Support

Mood Disturbance Clinical Trial

— CARING  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04812665
• Other study ID #: CAR-0220
• Status: Completed
• Start date: May 17, 2021
• Est. completion date: August 12, 2022

Study information

• Verified date: March 2023
• Source: Adhera Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 undergoing Growth Hormone treatment (GHt).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 12, 2022
• Est. primary completion date: August 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emotional Adjustment
• Mood Disturbance

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Miguel Servet	Zaragoza	Aragón

Sponsors (3)

Lead Sponsor	Collaborator
Adhera Health, Inc.	Hospital Miguel Servet, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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".	3 Months
Secondary	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.	3 Months
Secondary	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.	3 Months
Secondary	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.	3 Months
Secondary	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.	3 Months
Secondary	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.	3 Months
Secondary	Behavioral outcome: Treatment adherence	Adherence to the Growth Hormone treatment (GHt) will be measured with the data collected by the Easypod Connect device.	3 Months
Secondary	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.	6 Months