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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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).
- Conditions
- Diabetes Mellitus, Type 1
- 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 group | Role | What they receive |
|---|---|---|
| Qualitative sub-study 1 group | Experimental | One 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 group | Experimental | A 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.
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
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)
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
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
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
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
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
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
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
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
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.
- First posted2 Aug 2022
- Study start1 Oct 2022
- Primary completion14 Dec 2023
- Study completion14 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Adhera Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Miguel Servet, Novo Nordisk A/S
- Responsible party
- Sponsor
- Investigators
- Antonio de Arriba Muñoz, MD, PhD, Principal investigator, Unidad de Endocrinología Pediátrica, Hospital Miguel ServetLuis Fernandez Luque, PhD, Principal investigator, Adhera Health, Inc.
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARING: Feasibility Study of Digital Health for Caregivers Emotional and Self-management Support of Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05483803
- Acronym / sponsor ID
- CARING-T1D / CAR-22-001
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Type 1 Diabetes, mhealth, caregiver, emotional health, behavioral intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Adhera Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hospital Miguel Servet, Novo Nordisk A/S
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Qualitative sub-study 1 group | Experimental | Behavioral: Adhera® Caring digital intervention for Type 1 DiabetesOne group of caregivers (n = 20) will engage with the digital health solution during 1 month. |
| Quantitative sub-study 2 group | Experimental | Behavioral: Adhera® Caring digital intervention for Type 1 DiabetesA different group of caregivers (n = 80) will engage with the digital health solution during 3 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adhera® Caring digital intervention for Type 1 DiabetesThe Adhera® Caring is a mobile based personalized digital intervention for caregivers, lasting for 1 or 3 months (depending on the sub-study). | Behavioural | Qualitative sub-study 1 group, Quantitative sub-study 2 group |
Primary outcome
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
A semi-structured interview based on a mental health and technology acceptance theoretical framework has been specifically designed for this purpose.
Sub-study 2: Changes on caregiver's positive mood
Time frame: 3 Months
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.
9 secondary outcomes
Emotional outcome: Changes on caregiver's distress
Time frame: Baseline up to week 12
Emotional outcome: Changes on caregiver's general wellbeing
Time frame: Baseline up to week 12
Emotional outcome: Changes on caregiver's perceived self-efficacy
Time frame: Baseline up to week 12
Health-related Quality of Life (HrQoL): Changes on the child's HRQoL
Time frame: Baseline up to week 12
Life-style outcome: Adherence to Mediterranean diet
Time frame: Baseline up to week 12
Life-style outcome: physical activity (APALQ)
Time frame: Baseline up to week 12
Knowledge of the disease and its treatment.
Time frame: Baseline up to week 12
Behavioral outcome: objectively measured children's metabolic control to the treatment
Time frame: Baseline up to week 12
Behavioral outcome: Usability
Time frame: At week 4 (sub-study 1) or week 12 (sub-study 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Background: PubMed 32338624Carrasco-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio de Arriba Muñoz, MD, PhD principal investigator
Unidad de Endocrinología Pediátrica, Hospital Miguel Servet
Luis Fernandez Luque, PhD principal investigator
Adhera Health, Inc.
1 site in 1 country: see every site and its status.
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.