NCT05648383

Brief Summary

The DigiCare4You project will use digital tools for early screening, prevention and management of type 2 diabetes (T2D) and hypertension (HTN). An implementation study will be conducted, targeting more than 10,000 families in two Middle Income Countries (Albania and Bulgaria) and two High Income Countries (Greece and Spain), considering vulnerable groups. Schools will be used as an entry point to the community. Building on an existing procedure for children's periodic growth assessment, conducted by school nurses or in collaboration with local community health centers, parents/ caregivers will be screened via a non-invasive self-reported digital screening tool. Those identified at high risk for T2D will be referred for glycaemia testing (fasting plasma glucose and glycated hemoglobin, HbA1c), as well as blood pressure (BP) measurements, at local community health centers. Parents/ caregivers confirmed to have pre-diabetes or diabetes (and possibly high BP) will be invited to join a mHealth self-management intervention coordinated by the community healthcare workforce. The goal of this intervention is to involve high-risk adults in the treatment process and decision-making on personalized behavioral goals (e.g. diet, physical activity, smoking, alcohol, medication compliance) that meet their needs, and ultimately improve the health status of parents/caregivers, as well as the lifestyle of the entire family.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
992

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable type-2-diabetes

Geographic Reach
4 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

2.4 years

First QC Date

November 28, 2022

Last Update Submit

December 5, 2022

Conditions

Type 2 DiabetesPreDiabetesHypertension

Keywords

communityprimary healthcarefamiliesm-health applicationdiabeteshypertensionscreeninglifestyle interventionself-managementpeople-centred carescaling-up

Outcome Measures

Primary Outcomes (4)

  • Change from Baseline in fasting plasma glucose [FPG] at 12 months (1st follow-up)

    Fasting plasma glucose \[FPG\] is measured in participants with T2D and in participants with prediabetes at 12 months (1st follow-up) from baseline.

    Baseline and 12 months (1st follow-up)

  • Change from Baseline in fasting plasma glucose [FPG] at 24 months (2nd follow-up)

    Fasting plasma glucose \[FPG\] is measured in participants with T2D and in participants with prediabetes at 24 months (2nd follow-up) from baseline.

    Baseline and 24 months (2nd follow-up)

  • Change from Baseline in glycated hemoglobin [HbA1c] at 12 months (1st follow-up)

    Glycated hemoglobin \[HbA1c\] is measured in participants with T2D and in participants with prediabetes at 12 months (1st follow-up) from baseline.

    Baseline and 12 months (1st follow-up)

  • Change from Baseline in glycated hemoglobin [HbA1c] at 24 months (2nd follow-up)

    Glycated hemoglobin \[HbA1c\] is measured in participants with T2D and in participants with prediabetes at 24 months (2nd follow-up) from baseline.

    Baseline and 24 months (2nd follow-up)

Secondary Outcomes (6)

  • Change from Baseline in blood pressure [BP] at 12 months (1st follow-up)

    Baseline and 12 months (1st follow-up)

  • Change from Baseline in blood pressure [BP] at 24 months (2nd follow-up)

    Baseline and 24 months (2nd follow-up)

  • Change from Baseline in body weight [BW] at 12 months (1st follow-up)

    Baseline and 12 months (1st follow-up)

  • Change from Baseline in body weight [BW] at 24 months (2nd follow-up)

    Baseline and 24 months (2nd follow-up)

  • Change from Baseline in waist circumference [WC] at 12 months (1st follow-up)

    Baseline and 12 months (1st follow-up)

  • +1 more secondary outcomes

Other Outcomes (2)

  • Change form Baseline in the BMI z-score of children at 12 months (1st follow-up)

    Baseline and 12 months (1st follow-up)

  • Change form Baseline in the BMI z-score of children at 24 months (2nd follow-up)

    Baseline and 24 months (2nd follow-up)

Study Arms (4)

Pre-diabetes group, mHealth intervention

EXPERIMENTAL

Participants will receive mHealth intervention (mobile apps) and counseling sessions along with standard care

Behavioral: mHealth intervention

Diabetes group, mHealth intervention

EXPERIMENTAL

Participants will receive mHealth intervention (mobile apps) and counseling sessions along with standard care

Behavioral: mHealth intervention

Prediabetes group, control

ACTIVE COMPARATOR

Participants will receive standard care, including lifestyle recommendations

Behavioral: Standard care

Diabetes group, control

ACTIVE COMPARATOR

Participants will receive standard care, including lifestyle recommendations

Behavioral: Standard care

Interventions

mHealth interventionBEHAVIORAL

Participants will receive mHealth intervention (mobile apps) and counseling sessions along with standard care

Diabetes group, mHealth interventionPre-diabetes group, mHealth intervention
Standard careBEHAVIORAL

Participants will receive standard care, including lifestyle recommendations.

Diabetes group, controlPrediabetes group, control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People who have their permanent residence within the prefecture/region of the relevant facility participating in the clinical study.
  • People having children at primary and/ or secondary education.
  • People who are physically and mentally able to provide their informed consent to participate.
  • People with a FINDRISC ≥10
  • People with a fasting plasma glucose (FPG) ≥ 100 mg/dL and /or glycated hemoglobin (HbA1c) ≥ 5.7%

You may not qualify if:

  • People suffering from a health condition where adherence to the intervention will be contraindicated or improbable.
  • People unable to express a free and informed consent for medical and/or psychological conditions, mental incapacity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Universiteti i Mjekësisë

Tirana, Rruga E Dibrës, AL1005, Albania

RECRUITING

Medical University of Varna

Varna, 9002, Bulgaria

RECRUITING

Harokopio University

Athens, Attica, 17676, Greece

RECRUITING

Universidad de Zaragoza

Zaragoza, 50009, Spain

RECRUITING

Related Publications (6)

  • Manios Y, Mavrogianni C, Lambrinou CP, Cardon G, Lindstrom J, Iotova V, Tankova T, Civeira F, Kivela J, Jancso Z, Shadid S, Tsochev K, Mateo-Gallego R, Rado S, Dafoulas G, Makrilakis K, Androutsos O; Feel4Diabetes-study group. Two-stage, school and community-based population screening successfully identifies individuals and families at high-risk for type 2 diabetes: the Feel4Diabetes-study. BMC Endocr Disord. 2020 Mar 12;20(Suppl 1):12. doi: 10.1186/s12902-019-0478-9.

    PMID: 32164646RESULT

  • Manios Y, Androutsos O, Lambrinou CP, Cardon G, Lindstrom J, Annemans L, Mateo-Gallego R, de Sabata MS, Iotova V, Kivela J, Martinez R, Moreno LA, Rurik I, Schwarz P, Tankova T, Liatis S, Makrilakis K. A school- and community-based intervention to promote healthy lifestyle and prevent type 2 diabetes in vulnerable families across Europe: design and implementation of the Feel4Diabetes-study. Public Health Nutr. 2018 Dec;21(17):3281-3290. doi: 10.1017/S1368980018002136. Epub 2018 Sep 12.

    PMID: 30207513RESULT

  • Lindstrom J, Tuomilehto J. The diabetes risk score: a practical tool to predict type 2 diabetes risk. Diabetes Care. 2003 Mar;26(3):725-31. doi: 10.2337/diacare.26.3.725.

    PMID: 12610029RESULT

  • Mavrogianni C, Lambrinou CP, Androutsos O, Lindstrom J, Kivela J, Cardon G, Huys N, Tsochev K, Iotova V, Chakarova N, Rurik I, Moreno LA, Liatis S, Makrilakis K, Manios Y; Feel4Diabetes-study group. Evaluation of the Finnish Diabetes Risk Score as a screening tool for undiagnosed type 2 diabetes and dysglycaemia among early middle-aged adults in a large-scale European cohort. The Feel4Diabetes-study. Diabetes Res Clin Pract. 2019 Apr;150:99-110. doi: 10.1016/j.diabres.2019.02.017. Epub 2019 Feb 20.

    PMID: 30796939RESULT

  • Oldenburg B, Taylor CB, O'Neil A, Cocker F, Cameron LD. Using new technologies to improve the prevention and management of chronic conditions in populations. Annu Rev Public Health. 2015 Mar 18;36:483-505. doi: 10.1146/annurev-publhealth-031914-122848. Epub 2015 Jan 12.

    PMID: 25581147RESULT

  • O'Neil A, Cocker F, Rarau P, Baptista S, Cassimatis M, Barr Taylor C, Lau AYS, Kanuri N, Oldenburg B. Using digital interventions to improve the cardiometabolic health of populations: a meta-review of reporting quality. J Am Med Inform Assoc. 2017 Jul 1;24(4):867-879. doi: 10.1093/jamia/ocw166.

    PMID: 28339628RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Prediabetic StateHypertensionDiabetes Mellitus

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Yannis Manios, Professor

    Harokopio University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yannis Manios, Professor

CONTACT

2109549156manios@hua.gr

Christina Mavrogianni, Dr

CONTACT

2109549353cmavrog@hua.gr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 28, 2022

First Posted

December 13, 2022

Study Start

October 1, 2022

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

December 13, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) will be shared with the project partners and third parties.Although a preliminary version of the Data Management Plan has been developed, there are still a few points to be finalized, including the time frame with respect to data availability, the access criteria regarding how requests for information will be reviewed, and if a web address will be used to share IPD.

Time Frame
This has not been decided yet.
Access Criteria
For the duration of the project, data will be stored in a Secure Cloud-Based Repository, managed by the Project Coordinator who will authorize access to project partners' staff; when partners or partners' staff leave the project, the access to the repository will be disabled. Third parties will be granted access to the data for research purposes, including validation of the results presented in scientific publications.

Locations

ES(1)BU(1)GR(1)AL(1)