Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06436456
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-05-03
Brief Title:
Use of an Online Intervention for the Treatment of Diabetes Distress in Patients With Type 1-Diabetes
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
The Feasibility Acceptability and Preliminary Effectiveness of an Internet-based Intervention for Diabetes Distress in Patients With Type 1 Diabetes
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
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:
This study will investigate whether an online intervention can be helpful in reducing diabetes distress in people with type 1 diabetes and elevated diabetes distress compared to individual counselling sessions online phone-based or face-to-face depending on the preference of the person with type 1 diabetes Half of the participants will receive the online intervention while the other half will receive individual counseling sessions with a psychologist
Objectives The main aim of this study is to investigate if the online intervention is feasible and liked by people with type 1 diabetes and diabetes distress in comparison with individual counselling sessions
Hypotheses The investigators predict that both interventions will be feasible to use shown by how many people join stay engaged and complete the interventions The investigators also think that people will find both interventions acceptable as shown by the positive feedback given in interviews after they finish
Objectives The main aim of this study is to investigate if the online intervention is feasible and liked by people with type 1 diabetes and diabetes distress in comparison with individual counselling sessions
Hypotheses The investigators predict that both interventions will be feasible to use shown by how many people join stay engaged and complete the interventions The investigators also think that people will find both interventions acceptable as shown by the positive feedback given in interviews after they finish
Detailed Description:
Individuals with diabetes are primarily responsible for managing their disease Therefore their ability to effectively self-treat their diabetes is critical for their prognosis These significant treatment responsibilities place considerable demands on individual patients These demands can lead to high levels of diabetes distress Diabetes distress encompasses the emotional distress arising from the constant self-care burden that is required to self-manage diabetes but also feelings of insufficient support and understanding from others and challenges in communication with healthcare professionals Diabetes distress is prevalent among individuals with diabetes International research indicates that approximately 20-25 of individuals with diabetes experience high levels of diabetes distress Studies exploring the impact of diabetes distress on diabetes management reveal that significant diabetes distress not only diminishes overall well-being but also correlates with suboptimal self-management of diabetes This includes insufficient physical activity unhealthy dietary choices reduced medication adherence infrequent blood glucose monitoring and elevated HbA1c levels
At Steno Diabetes Center Odense SDCO there are provisions for individual psychological intervention aimed at patients facing psychological challenges associated with their diabetes However due to resource constraints priority is given to those patients experiencing the most severe impact
As part of a new initiative at SDCO Patient-Reported Outcome PRO data has been incorporated alongside diabetes same-day micro- and macrovascular complication screening which includes an assessment of mental well-being ie diabetes distress These assessments will contribute to higher recognition rates of elevated diabetes distress thereby exacerbating the strain on already limited resources available for individual psychological intervention Moreover not all patients may have the requisite time necessity or opportunity to partake in such individual intervention
In order to expand existing psychological services at SDCO in an affordable way an online psychological intervention needs to be developed The objective of the online psychological intervention is to cater to a larger group of people with type 1 diabetes who can autonomously engage with evidence-based components of the intervention thereby averting the progression of patients diabetes distress towards adverse or pathological conditions such as anxiety or depression Studies indicate that therapist-supported online therapy yields comparable efficacy to traditional face-to-face therapy Additionally online therapy offers the benefit of flexibility allowing patients to engage with the intervention at their convenience thereby obviating the need for patients to take time away from their professional commitments to attend sessions with a psychologist
Aims
The primary aim of this study is to evaluate the feasibility and acceptability of an online intervention with written support for patients with type 1-diabetes and elevated diabetes distress comparing this with an individual intervention by a psychologist online phone-based or face-to-face depending on the preference of the person with type 1 diabetes Following the intervention qualitative data will be collected through interviews conducted with both patients and clinical staff to assess this aim Also metadata from the platform of the online intervention will be collected to evaluate this aim
A secondary aim is to explore the efficacy of the interventions to improve different domains of diabetes-stress This secondary aim will be evaluated through survey data
Further aims are to explore whether both interventions impact diabetes-related quality of life acceptance of diabetes patient engagement in healthcare negative effects of the intervention useability of the intervention and glucometrics eg estimated HbA1c time in range TIR time above range TAR time below range TBR
Hypotheses
Primary aim hypotheses It is hypothesized that both interventions will show high feasibility and acceptability demonstrated by acceptable recruitment strategies high rates of retention and high completion of modulessessions It is expected though that the dropout rates will be higher in the online intervention group It is also hypothesized that both interventions are acceptable as demonstrated by satisfactory feedback obtained through post-intervention interviews
Secondary aim hypotheses It is hypothesized that in both interventions there will be a significant reduction in participants diabetes distress from pre-intervention to post-intervention and from pre-intervention to 3-months follow-up
Further it is also hypothesized that the interventions will yield positive changes in diabetes-related quality of life acceptance of diabetes and patient engagement in healthcare It is further hypothesized that the interventions has no negative effect on the patients and that the patients find the interventions useful Glucometrics are included as a secondary outcome but as the interventions does not target this the investigators hypothesize no changes in these measures will be found
Recruitment and procedure
Participants for the study will be recruited at Steno Diabetes Center Odense SDCO in Denmark Patients with a total score on the questionnaire Problem Areas in Diabetes PAID5 of 8 will receive information about the study If interested in participating they can contact the study leader to receive more information about the study and schedule a screening appointment with a study psychologist
During the screening appointment the patient will have further opportunity to learn more about the study and ask questions If they wish to participate they will receive a consent form to sign Subsequently the patient will receive a questionnaire including an extended measure of diabetes distress ie The Diabetes Distress Scale for type 1-diabetes DDS-type1 In the screening appointment the inclusion and exclusion criteria will be evaluated If the psychologist deems the patient suitable for participation the patient will be randomized to either receive an online psychological intervention or an individual psychological intervention with 20 patients in each arm
Following the conclusion of the intervention and during the 3-month follow-up period participants will be administered a questionnaire
Subsequent to the feasibility study semi-structured interviews will be conducted with approx 12 patients 2-3 psychologists and possibly further clinical staff These interviews will explore aspects related to screening procedures recruitment strategies and the acceptance of the online psychological intervention
The online intervention will subsequently be evaluated using a mini Model for Assessment of Telemedicine MAST where the following domains will be assessed
Health problems and technology characteristics
Patient safety
Clinical effectiveness
Patient assessment
Economic aspects
Organizational aspects
Sociocultural ethical and legal aspects
At Steno Diabetes Center Odense SDCO there are provisions for individual psychological intervention aimed at patients facing psychological challenges associated with their diabetes However due to resource constraints priority is given to those patients experiencing the most severe impact
As part of a new initiative at SDCO Patient-Reported Outcome PRO data has been incorporated alongside diabetes same-day micro- and macrovascular complication screening which includes an assessment of mental well-being ie diabetes distress These assessments will contribute to higher recognition rates of elevated diabetes distress thereby exacerbating the strain on already limited resources available for individual psychological intervention Moreover not all patients may have the requisite time necessity or opportunity to partake in such individual intervention
In order to expand existing psychological services at SDCO in an affordable way an online psychological intervention needs to be developed The objective of the online psychological intervention is to cater to a larger group of people with type 1 diabetes who can autonomously engage with evidence-based components of the intervention thereby averting the progression of patients diabetes distress towards adverse or pathological conditions such as anxiety or depression Studies indicate that therapist-supported online therapy yields comparable efficacy to traditional face-to-face therapy Additionally online therapy offers the benefit of flexibility allowing patients to engage with the intervention at their convenience thereby obviating the need for patients to take time away from their professional commitments to attend sessions with a psychologist
Aims
The primary aim of this study is to evaluate the feasibility and acceptability of an online intervention with written support for patients with type 1-diabetes and elevated diabetes distress comparing this with an individual intervention by a psychologist online phone-based or face-to-face depending on the preference of the person with type 1 diabetes Following the intervention qualitative data will be collected through interviews conducted with both patients and clinical staff to assess this aim Also metadata from the platform of the online intervention will be collected to evaluate this aim
A secondary aim is to explore the efficacy of the interventions to improve different domains of diabetes-stress This secondary aim will be evaluated through survey data
Further aims are to explore whether both interventions impact diabetes-related quality of life acceptance of diabetes patient engagement in healthcare negative effects of the intervention useability of the intervention and glucometrics eg estimated HbA1c time in range TIR time above range TAR time below range TBR
Hypotheses
Primary aim hypotheses It is hypothesized that both interventions will show high feasibility and acceptability demonstrated by acceptable recruitment strategies high rates of retention and high completion of modulessessions It is expected though that the dropout rates will be higher in the online intervention group It is also hypothesized that both interventions are acceptable as demonstrated by satisfactory feedback obtained through post-intervention interviews
Secondary aim hypotheses It is hypothesized that in both interventions there will be a significant reduction in participants diabetes distress from pre-intervention to post-intervention and from pre-intervention to 3-months follow-up
Further it is also hypothesized that the interventions will yield positive changes in diabetes-related quality of life acceptance of diabetes and patient engagement in healthcare It is further hypothesized that the interventions has no negative effect on the patients and that the patients find the interventions useful Glucometrics are included as a secondary outcome but as the interventions does not target this the investigators hypothesize no changes in these measures will be found
Recruitment and procedure
Participants for the study will be recruited at Steno Diabetes Center Odense SDCO in Denmark Patients with a total score on the questionnaire Problem Areas in Diabetes PAID5 of 8 will receive information about the study If interested in participating they can contact the study leader to receive more information about the study and schedule a screening appointment with a study psychologist
During the screening appointment the patient will have further opportunity to learn more about the study and ask questions If they wish to participate they will receive a consent form to sign Subsequently the patient will receive a questionnaire including an extended measure of diabetes distress ie The Diabetes Distress Scale for type 1-diabetes DDS-type1 In the screening appointment the inclusion and exclusion criteria will be evaluated If the psychologist deems the patient suitable for participation the patient will be randomized to either receive an online psychological intervention or an individual psychological intervention with 20 patients in each arm
Following the conclusion of the intervention and during the 3-month follow-up period participants will be administered a questionnaire
Subsequent to the feasibility study semi-structured interviews will be conducted with approx 12 patients 2-3 psychologists and possibly further clinical staff These interviews will explore aspects related to screening procedures recruitment strategies and the acceptance of the online psychological intervention
The online intervention will subsequently be evaluated using a mini Model for Assessment of Telemedicine MAST where the following domains will be assessed
Health problems and technology characteristics
Patient safety
Clinical effectiveness
Patient assessment
Economic aspects
Organizational aspects
Sociocultural ethical and legal aspects
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