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Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels (DIGICHOL)

Primary Purpose

Hypercholesterolemia, Dyslipidemias

Status
Not yet recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
lipodia
Sponsored by
Gaia AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring LDL-C, digital intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age >= 18 Of legal age (can differ from 18 in case the patient's nationality is not German) Diagnosis of hypercholesterolemia (ICD-10 E78.0, E78.2, E78.4, E78.5, E78.8, E78.9) confirmed by a laboratory test and physician diagnosis LDL-C levels above risk-adapted target triglyceride levels < 400 mg/dL Stability of potential drug treatment during the last 4 weeks Stability of potential hormonal treatment during the last 6 months Consent to participation Sufficient knowledge of the German language Exclusion Criteria: Homozygous Familial Hypercholesterolemia (FH), given that it is a genetic condition which is relatively unresponsive to lifestyle changes Hyperlipidemia type III, given that it is a genetic condition which is relatively unresponsive to lifestyle changes Patients receiving plasmapheresis Lp(a) > 50 mg/dL Current pregnancy Planned major operations Liver dysfunction End-stage renal failure Other systemic conditions that might interfere with successful study participation Plans to change drug treatment in the upcoming 6 months

Sites / Locations

  • GAIA AG

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Participants allocated to the intervention group will receive access to lipodia in addition to treatment as usual (TAU). lipodia is a digital health application designed for individuals with hypercholesterinemia, accessible through a web browser. The application focuses on treatment methods derived health behavior change and cognitive behavioral therapy (CBT). Topics addressed by lipodia are activity planning and impulse control, dietary habits, physical activity, stress management, mood management, sleep management, weight management, as well as quitting smoking and drinking. The program operates through interactive "dialogues", which are accompanied by illustrations, audio recordings, motivating text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 365 days.

Participants allocated to the control group will receive access to treatment as usual (TAU).

Outcomes

Primary Outcome Measures

Percent change in fasting LDL-C levels from baseline

Secondary Outcome Measures

Patients' activation
PAM-13
Percent change in fasting non-HDL-C levels from baseline
Percent change in fasting triglyceride levels from baseline
Responder analysis for LDL-C levels
% of patients reaching risk-adapted target
Percent change in fasting HDL-C levels from baseline
Health-related quality of life
AQoL-8D
BMI
Percent change in fasting LDL-C levels from baseline

Full Information

First Posted
August 3, 2023
Last Updated
August 31, 2023
Sponsor
Gaia AG
Collaborators
University Hospital, Aachen, Deutsche Stiftung für chronisch Kranke
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1. Study Identification

Unique Protocol Identification Number
NCT05988866
Brief Title
Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels
Acronym
DIGICHOL
Official Title
Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels in Individuals With LDL-cholesterol Levels Above Recommended Targets for Reducing Cardiovascular Risk: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gaia AG
Collaborators
University Hospital, Aachen, Deutsche Stiftung für chronisch Kranke

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This pragmatic randomized controlled trial (RCT) with 272 patients with hypercholesterolemia aims to investigate the effectiveness of lipodia, an unguided digital health intervention for patients with hypercholesterolemia on plasma lipid levels and other clinical variables. Inclusion criteria are: age ≥ 18 years, presence of hypercholesterolemia, low-density lipoprotein cholesterol (LDL-C) levels above the risk-adapted target, stability of potential drug treatments for at least four weeks, and stability of potential hormonal treatment for at least 6 months, next to provision of informed consent and sufficient knowledge of the German language. Exclusion criteria are plans to change potential drug treatment in the upcoming 6 months, the presence of homozygous familial hypercholesterolemia (FH) or type III hyperlipidemia, receiving plasmapheresis, Lp(a) > 50 mg/dL, triglyceride (TG) above 400 mg/dL, current pregnancy, planned major operations, liver dysfunction, end-stage renal failure, and other systemic diseases that might interfere with successful study participation. Patients will be randomized and allocated to either an intervention group, in which they will receive access to lipodia in addition to treatment as usual (TAU), or to a control group, in which they will receive only TAU. The primary endpoint will be a change in plasma LDL-C levels, with six months post-allocation (T2) being the primary timepoint for assessment of effectiveness. Three months post-allocation (T1) will serve as early-response assessment of endpoints. Secondary endpoints will be patient activation, the change in levels of other plasma lipids (non-high-density lipoprotein cholesterol (non-HDL-C), high-density lipoprotein cholesterol (HDL), TG), responder rate of LDL-C, self-reported health-related quality of life, and BMI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Dyslipidemias
Keywords
LDL-C, digital intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Study visit staff and the laboratory are blinded regarding the patient's study group.
Allocation
Randomized
Enrollment
272 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Participants allocated to the intervention group will receive access to lipodia in addition to treatment as usual (TAU). lipodia is a digital health application designed for individuals with hypercholesterinemia, accessible through a web browser. The application focuses on treatment methods derived health behavior change and cognitive behavioral therapy (CBT). Topics addressed by lipodia are activity planning and impulse control, dietary habits, physical activity, stress management, mood management, sleep management, weight management, as well as quitting smoking and drinking. The program operates through interactive "dialogues", which are accompanied by illustrations, audio recordings, motivating text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 365 days.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants allocated to the control group will receive access to treatment as usual (TAU).
Intervention Type
Behavioral
Intervention Name(s)
lipodia
Intervention Description
Participants will receive access to the digital health intervention lipodia in addition to TAU.
Primary Outcome Measure Information:
Title
Percent change in fasting LDL-C levels from baseline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Patients' activation
Description
PAM-13
Time Frame
6 months
Title
Percent change in fasting non-HDL-C levels from baseline
Time Frame
6 months
Title
Percent change in fasting triglyceride levels from baseline
Time Frame
6 months
Title
Responder analysis for LDL-C levels
Description
% of patients reaching risk-adapted target
Time Frame
6 months
Title
Percent change in fasting HDL-C levels from baseline
Time Frame
6 months
Title
Health-related quality of life
Description
AQoL-8D
Time Frame
6 months
Title
BMI
Time Frame
6 months
Title
Percent change in fasting LDL-C levels from baseline
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Patients' activation
Description
PAM-13
Time Frame
3 months
Title
Percent change in fasting non-HDL-C levels from baseline
Time Frame
3 months
Title
Percent change in fasting triglyceride levels from baseline
Time Frame
3 months
Title
Percent change in fasting HDL-C levels from baseline
Time Frame
3 months
Title
Responder analysis for LDL-C levels
Description
% of patients reaching risk-adapted target
Time Frame
3 months
Title
Health-related quality of life
Description
AQoL-8D
Time Frame
3 months
Title
BMI
Time Frame
3 months
Title
Health literacy
Description
HLQ
Time Frame
6 months
Title
Perceived efficacy in patient-physician-interactions
Description
PEPPI-5
Time Frame
6 months
Title
Autonomy preference
Description
API
Time Frame
6 months
Title
Percent change in fasting remnant cholesterol levels (non-HDL-C minus LDL-C)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >= 18 Of legal age (can differ from 18 in case the patient's nationality is not German) Diagnosis of hypercholesterolemia (ICD-10 E78.0, E78.2, E78.4, E78.5, E78.8, E78.9) confirmed by a laboratory test and physician diagnosis LDL-C levels above risk-adapted target triglyceride levels < 400 mg/dL Stability of potential drug treatment during the last 4 weeks Stability of potential hormonal treatment during the last 6 months Consent to participation Sufficient knowledge of the German language Exclusion Criteria: Homozygous Familial Hypercholesterolemia (FH), given that it is a genetic condition which is relatively unresponsive to lifestyle changes Hyperlipidemia type III, given that it is a genetic condition which is relatively unresponsive to lifestyle changes Patients receiving plasmapheresis Lp(a) > 50 mg/dL Current pregnancy Planned major operations Liver dysfunction End-stage renal failure Other systemic conditions that might interfere with successful study participation Plans to change drug treatment in the upcoming 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Björn Meyer, PhD
Phone
+49.176.1039.2337
Email
bjoern.meyer@gaia-group.com
First Name & Middle Initial & Last Name or Official Title & Degree
Antje Riepenhausen, M.Sc.
Email
antje.riepenhausen@gaia-group.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk Müller-Wieland, MD
Organizational Affiliation
Klinisches Studienzentrum, Medizinische Klinik I, Universitätsklinikum Aachen, Pauwelsstraße 30, 52074 Aachen
Official's Role
Principal Investigator
Facility Information:
Facility Name
GAIA AG
City
Hamburg
ZIP/Postal Code
22085
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Björn Meyer, PhD
Email
bjoern.meyer@gaia-group.com
First Name & Middle Initial & Last Name & Degree
Antje Riepenhausen, M.Sc.
Email
antje.riepenhausen@gaia-group.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels

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