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Diabetes Mellitus, Type 1CARING-T1DNCT05483803

Digital Health Intervention for Caregivers Emotional and Self-management Support of Children With Type 1 Diabetes

A study testing Adhera® Caring digital intervention for Type 1 Diabetes in people with Diabetes Mellitus, Type 1, 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 mobile-based novel digital health solution based on emotional and behavioral change techniques, to provide emotional and self-management tailored support to caregivers of children with… Read more about this study

Who is it for?
Any age
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Adhera® Caring digital intervention for Type 1 Diabetes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSpain
Study dates
1 Oct 2022to 14 Dec 2023
Phase
Interventional
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Caregiver of patients with type 1 diabetes under 18 years of age.
  • Patient's debut of type 1 diabetes at least 3 months prior to the start of the study.
  • Patients with continuous glucose monitoring.
  • Participants with children undergoing insulin treatments (multiple dose insulin or continuous subcutaneous insulin infusion)
  • Participants administering insulin treatment to their children
  • Users of smartphone whose children are treated with type 1 diabetes treatment for approved indications in Spain.
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  • Participants must agree on sharing data on continuous glucose monitoring data of their treated children.
  • Participants must sign an informed consent
  • Participants must be willing to and install the mobile solution of the study.

Who cannot join

  • Candidates without a smartphone 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 Miguel Servet

    Zaragoza, Aragon, 50009

Other trials in Spain

About this study

Official title: CARING: Feasibility Study of Digital Health for Caregivers Emotional and Self-management Support of Children With Type 1 Diabetes

This feasibility study builds upon mental health and technology acceptance theoretical frameworks. It seeks to examine potentials of a mobile-based novel digital health solution based on emotional and behavioral change techniques, to provide emotional and self-management tailored support to caregivers of children with type I diabetes (T1D).

The digital health program, called Adhera® Caring, is designed to be used for approximately 3 months. The study will enroll 100 participants (20 in sub-study 1 and 80 in sub-study 2) who are caregivers of children with type 1 diabetes. There will be a nurse coaching the participants by providing support related to their emotional wellbeing via the mobile solution.

Read the detailed description

Objectives:

  • Primary objective 1. To gather qualitative and quantitative information enabling to better understand psychological burdens that caregivers of children with type 1 diabetes and perceived barriers/facilitators for adoption of a digital health solution.
  • Primary objective 2. To assess positive mood states of caregivers of type 1 diabetes patients as an indicator of emotional wellbeing related to the use of the digital health solution.

This is a prospective mixed-methods (qualitative-quantitative) exploratory study composed of two sub-studies:

  • Qualitative sub-study 1 (SS1): One group of caregivers (n = 20) will engage with the digital health solution for 1 month. Subsequently, an individual semi-structured interview with each of the participants and a usability questionnaire will proceed to gather user experience qualitative information.
  • Quantitative sub-study 2 (SS2): A different group of caregivers (n = 80) will engage with the digital health solution for 3 months. As elaborated in the following sections, a quantitative approach will be adopted to assess different emotional and behavioral parameters before and after engaging with the digital health solution (pre-post design).
Being tested
Adhera® Caring digital intervention for Type 1 Diabetes
Keywords
Type 1 Diabetes, mhealth, caregiver, emotional health, behavioral intervention
Medical subject headings
Diabetes Mellitus, Type 1, Psychological Well-Being

What participants receive

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

  • Adhera® Caring digital intervention for Type 1 DiabetesBehavioural

    The Adhera® Caring is a mobile based personalized digital intervention for caregivers, lasting for 1 or 3 months (depending on the sub-study).

Study groups in NCT05483803
Study groupRoleWhat they receive
Qualitative sub-study 1 groupExperimentalOne group of caregivers (n = 20) will engage with the digital health solution during 1 month.
Receives: Behavioral: Adhera® Caring digital intervention for Type 1 Diabetes
Quantitative sub-study 2 groupExperimentalA different group of caregivers (n = 80) will engage with the digital health solution during 3 months.
Receives: Behavioral: Adhera® Caring digital intervention for Type 1 Diabetes

What is being measured

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

  1. Sub-study 1: Qualitative data of psychological burdens experienced as caregivers of children with type 1 diabetes and barriers/facilitators for adopting the digital health 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 (9)

  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: Baseline up to week 12

  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: Baseline up to week 12

  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: Baseline up to week 12

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

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

    Measured: Baseline up to week 12

  5. Life-style outcome: Adherence to Mediterranean diet

    Assessed with the KIDMED questionnaire. This questionnaire consists of 16 questions, where negative answers are scored with 0, while affirmative answers are scored with +1/-1 depending on their positive or negative connotation.

    Measured: Baseline up to week 12

  6. Life-style outcome: physical activity (APALQ)

    Physical activity assessed with Assessment Physical Activity Levels Questionnaire (APALQ). It is a self-administered questionnaire with 5 items scored 1 to 4/5, in which the sum of the answers classifies the global score in 3 categories: sedentary (5 to 10), moderately active (11-16), very active (+17).

    Measured: Baseline up to week 12

  7. Knowledge of the disease and its treatment.

    Medical checking questions related to the disease, its treatment and if the patients are following the multiple doses of insulin (MDI) or the continuous subcutaneous insulin infusion (CSII) treatment.

    Measured: Baseline up to week 12

  8. Behavioral outcome: objectively measured children's metabolic control to the treatment

    Assessed from the sensor used via glucose monitoring

    Measured: Baseline up to week 12

  9. 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: At week 4 (sub-study 1) or week 12 (sub-study 2)

Timeline

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

  1. First posted2 Aug 2022
  2. Study start1 Oct 2022
  3. Primary completion14 Dec 2023
  4. Study completion14 Dec 2023

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Sequential
Model description
Participants will be enrolled in two sub-studies. Participants in sub-study 1 will be enrolled in an intervention for 1 month. After sub-study 1 completion a new group of participants will be enrolled in the sub-study 2 for the intervention lasting 3 months.
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05483803
Sponsor's protocol ID
CAR-22-001
Other IDs
U1111-1280-9100
Acronym
CARING-T1D
Status last verified
Jan 2024
First submitted
28 Jul 2022
Last updated
1 Feb 2024
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

Questions about this trial

What is this clinical trial studying?

A study testing Adhera® Caring digital intervention for Type 1 Diabetes in people with Diabetes Mellitus, Type 1, 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 9 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 1 Feb 2024. 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: Qualitative data of psychological burdens experienced as caregivers of children with type 1 diabetes and barriers/facilitators for adopting the digital health 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 NCT05483803, which also lists 1 linked publication.

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 1 Feb 2024.

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