Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04691973
Status:
UNKNOWN
Last Update Posted:
2020-12-31
First Post:
2020-12-30
Brief Title:
Evaluation of Health and Lifestyle Tool
Sponsor:
Region Skane
Organization:
Region Skane
Study Overview
Official Title:
Evaluation of the Digital Health and Lifestyle Tool
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall aim of the study is to observe the natural pattern of usage and metabolic outcomes in patients with type 2 diabetes who had access to the new digital tool as a stand-alone support in addition to usual care The tool is based on self-affirmation theory and has large emphasis on self-reflection to enable sustainable lifestyle changes The changes in HbA1c reflecting long-term blood glucose will be evaluated in patients with type 2 diabetes Patients are compared to controls on usual care not exposed to the tool
Detailed Description:
Considerable evidence suggest that lifestyle changes can prevent or delay the onset of type 2 diabetes and self-care behaviors largely determine HbA1c Modifiable lifestyle factors have been established as key drivers of disease onset progression and prognosis motivating the use of lifestyle as medicine Despite this a substantial number of patients with type 2 diabetes T2D have difficulties attaining adequate glycemic control
Digital health tools are increasingly incorporated into diabetes care and have the potential to improve both behavioral and clinical outcomes on a broad basis However low levels of uptake reduced user engagement over time and low acceptance among patients raise concerns about their effectiveness Knowledge on how to design interventions aimed at inducing change by promoting motivation and personal engagement as well as a better understanding of patient interaction with digital health interventions could help overcome these challenges and inform the development of a novel and effective health support
The objective or this study is to evaluate a new web-based tool developed at the University Gothenburg Sweden that aims to support patient autonomy and motivation to make sustainable lifestyle changes
The investigators will test the hypothesis that individuals with type 2 diabetes in routine care who have access to the tool get improved HbA1c relative to baseline as compared with individuals with type 2 diabetes on usual care not exposed to the tool
The study is an investigator-initiated single-center study conducted at Scania University Hospital Sweden and will follow participants over three years
Participants with type 2 diabetes will be recruited by sending letters with study information to patients with type 2 diabetes in the region If HbA1c is 52 mmolmol or above participants are included and attend study visits at Scania University Hospital every three months during the first year and every sixth month during the following two years for blood sampling and physical examination
During the first 3 months only half of the participants get access to the tool immediately and the other half remain on usual care randomized who get access or not After 3 months all participants get access to the tool and used it during an open-label observation period of up to three years
Study visits Every physical study visit lasts appr 20 minutes and includes measurements of length and weight blood pressure and estimations of fat and muscle mass by bioimpedance Fasting blood samples are taken for analysis of HbA1c and other cardiometabolic proteins Participants will not receive any counselling or lifestyle advice at the study visits Technical problems are referred to the study coordinator who may also respond to requests to clarify content in a general manner without providing personal advice Patients are followed by their ordinary physician throughout the study ie the tool is provided on top of ordinary anti-diabetic treatment and healthcare contacts
The tool The tool is web-based and used via a computer or mobile phone It is used at each individuals preferred pace but participants are recommended to login at least every other week Every round the participants choose a themes out of appr 80 possible covering eg food exercise stress self-reflection aspects which takes appr 15-30 minutes to complete Participants then reflect on the content and how it could be implemented in daily life When returning for next round participants are asked to reflect on any changes done since last time There is no interaction between individual participants
Statistics The study has two primary endpoints One primary endpoint is change of HbA1c between participants with and without access to the tool during the first 3-month period Patients lost to follow-up will not be included in the analysis
The standard deviation of change of HbA1c is 6 mmolmol over 3 months With 80 power at alpha005 142 participants are needed to each randomization arm to detect a significant difference between the groups assuming that the true treatment effect of the intervention is 2 mmolmol over 3 months
Enrollment will continue until the required number of participants are reached accounting for those lost to follow-up during the randomization period The participants use the tool at their own pace but are within the tool recommended to complete a theme at least every other week to enable implementation of changes and maintain an awareness of the tool and its content
As another primary endpoint investigators will during the open-label observation period compare change of HbA1c at one year relative to baseline between patients using the tool as recommended at least every other week and matched controls on usual care 12 ratio between exposed and controls The controls are matched on gender age BMI and HbA1c from existing clinical registries in the region
The standard deviation of DeltaHbA1c is 7 mmolmol over one year With 80 power at alpha005 24 participants using the tool as recommended and 48 matched controls are needed to detect a significant difference between the groups assuming that the true treatment effect of the intervention is 5 mmolmol
Subanalysis of MOD patients A data-driven cluster analysis of 9000 diabetes patients has been performed in the ANDIS registry in Sweden based on six variables measured at diagnosis GAD antibodies age BMI HbA1c reflecting long-term blood glucose HOMA2-B reflecting insulin secretion and HOMA2-IR reflecting insulin resistance Four clusters of T2D patients were highlighted each with different characteristics and risk of complications One of these cluster MOD Mild Obesity-related Diabetes is characterized by high BMI and insulin resistance but relatively well-preserved insulin secretion It has been suggested that patients with MOD characteristics would benefit particularly from lifestyle changes The investigators therefore hypothesize that patients with MOD characteristics would benefit particularly well from the intervention As a subanalysis the investigators will analyse the interaction between MODnon-MOD subgroup and exposure to the intervention using a linear model with a term for the cluster variable a term for the exposure to the intervention and an interaction term
Digital health tools are increasingly incorporated into diabetes care and have the potential to improve both behavioral and clinical outcomes on a broad basis However low levels of uptake reduced user engagement over time and low acceptance among patients raise concerns about their effectiveness Knowledge on how to design interventions aimed at inducing change by promoting motivation and personal engagement as well as a better understanding of patient interaction with digital health interventions could help overcome these challenges and inform the development of a novel and effective health support
The objective or this study is to evaluate a new web-based tool developed at the University Gothenburg Sweden that aims to support patient autonomy and motivation to make sustainable lifestyle changes
The investigators will test the hypothesis that individuals with type 2 diabetes in routine care who have access to the tool get improved HbA1c relative to baseline as compared with individuals with type 2 diabetes on usual care not exposed to the tool
The study is an investigator-initiated single-center study conducted at Scania University Hospital Sweden and will follow participants over three years
Participants with type 2 diabetes will be recruited by sending letters with study information to patients with type 2 diabetes in the region If HbA1c is 52 mmolmol or above participants are included and attend study visits at Scania University Hospital every three months during the first year and every sixth month during the following two years for blood sampling and physical examination
During the first 3 months only half of the participants get access to the tool immediately and the other half remain on usual care randomized who get access or not After 3 months all participants get access to the tool and used it during an open-label observation period of up to three years
Study visits Every physical study visit lasts appr 20 minutes and includes measurements of length and weight blood pressure and estimations of fat and muscle mass by bioimpedance Fasting blood samples are taken for analysis of HbA1c and other cardiometabolic proteins Participants will not receive any counselling or lifestyle advice at the study visits Technical problems are referred to the study coordinator who may also respond to requests to clarify content in a general manner without providing personal advice Patients are followed by their ordinary physician throughout the study ie the tool is provided on top of ordinary anti-diabetic treatment and healthcare contacts
The tool The tool is web-based and used via a computer or mobile phone It is used at each individuals preferred pace but participants are recommended to login at least every other week Every round the participants choose a themes out of appr 80 possible covering eg food exercise stress self-reflection aspects which takes appr 15-30 minutes to complete Participants then reflect on the content and how it could be implemented in daily life When returning for next round participants are asked to reflect on any changes done since last time There is no interaction between individual participants
Statistics The study has two primary endpoints One primary endpoint is change of HbA1c between participants with and without access to the tool during the first 3-month period Patients lost to follow-up will not be included in the analysis
The standard deviation of change of HbA1c is 6 mmolmol over 3 months With 80 power at alpha005 142 participants are needed to each randomization arm to detect a significant difference between the groups assuming that the true treatment effect of the intervention is 2 mmolmol over 3 months
Enrollment will continue until the required number of participants are reached accounting for those lost to follow-up during the randomization period The participants use the tool at their own pace but are within the tool recommended to complete a theme at least every other week to enable implementation of changes and maintain an awareness of the tool and its content
As another primary endpoint investigators will during the open-label observation period compare change of HbA1c at one year relative to baseline between patients using the tool as recommended at least every other week and matched controls on usual care 12 ratio between exposed and controls The controls are matched on gender age BMI and HbA1c from existing clinical registries in the region
The standard deviation of DeltaHbA1c is 7 mmolmol over one year With 80 power at alpha005 24 participants using the tool as recommended and 48 matched controls are needed to detect a significant difference between the groups assuming that the true treatment effect of the intervention is 5 mmolmol
Subanalysis of MOD patients A data-driven cluster analysis of 9000 diabetes patients has been performed in the ANDIS registry in Sweden based on six variables measured at diagnosis GAD antibodies age BMI HbA1c reflecting long-term blood glucose HOMA2-B reflecting insulin secretion and HOMA2-IR reflecting insulin resistance Four clusters of T2D patients were highlighted each with different characteristics and risk of complications One of these cluster MOD Mild Obesity-related Diabetes is characterized by high BMI and insulin resistance but relatively well-preserved insulin secretion It has been suggested that patients with MOD characteristics would benefit particularly from lifestyle changes The investigators therefore hypothesize that patients with MOD characteristics would benefit particularly well from the intervention As a subanalysis the investigators will analyse the interaction between MODnon-MOD subgroup and exposure to the intervention using a linear model with a term for the cluster variable a term for the exposure to the intervention and an interaction term
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None