Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533423
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-04
Brief Title:
Effect of a Self-Management Intervention for Patients Newly Diagnosed With Inflammatory Arthritis The NISMA Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of a Self-Management Intervention for Patients Newly Diagnosed With Inflammatory Arthritis Study Protocol for a Randomized Controlled NISMA Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
In patients newly diagnosed with inflammatory arthritis a self-management intervention is anticipated to enhance self-management skills thereby improving patient function well-being and survival The primary objective of the trial is to investigate the short-term efficacy of the NISMA intervention and usual care compared to usual care alone control group on self-management skills and techniques in patients newly diagnosed with inflammatory arthritis
Method
This study aims to test the efficacy of the Newly diagnosed with Inflammatory arthritis - a Self-MAnagement intervention NISMA through a multicenter pragmatic randomized controlled trial RCT The trial will involve 130 patients newly diagnosed with IA from three Danish hospitals Participants will be randomly assigned to either the NISMA intervention group or a control group receiving usual care The NISMA intervention includes three mandatory individual sessions with a nurse supplemented by two optional group sessions over 12 months
Primary outcomes will be measured using the Health Education Impact Questionnaire heiQ focusing on the skill and technique acquisition domain Secondary outcomes include other heiQ domains quality of life loneliness physical function pain intensity pain self-efficacy anxiety and depression fatigue patient global assessment disease activity and medication adherence Data will be collected at baseline 12 months and 18 months post-baseline
Discussion
This RCT will provide essential insights into the effectiveness of a targeted self-management intervention for patients newly diagnosed with IA The NISMA intervention developed following the Medical Research Council Framework for complex interventions aims to improve self-management skills and overall QoL By addressing the unique challenges faced by newly diagnosed patients this study seeks to enhance the initial management of IA aligning with the European Alliance of Associations for Rheumatology EULAR recommendations for self-management support If successful the NISMA intervention could represent a significant advancement in the non-pharmacological management of IA offering a comprehensive patient-centered approach that addresses both physical and psychological needs
In patients newly diagnosed with inflammatory arthritis a self-management intervention is anticipated to enhance self-management skills thereby improving patient function well-being and survival The primary objective of the trial is to investigate the short-term efficacy of the NISMA intervention and usual care compared to usual care alone control group on self-management skills and techniques in patients newly diagnosed with inflammatory arthritis
Method
This study aims to test the efficacy of the Newly diagnosed with Inflammatory arthritis - a Self-MAnagement intervention NISMA through a multicenter pragmatic randomized controlled trial RCT The trial will involve 130 patients newly diagnosed with IA from three Danish hospitals Participants will be randomly assigned to either the NISMA intervention group or a control group receiving usual care The NISMA intervention includes three mandatory individual sessions with a nurse supplemented by two optional group sessions over 12 months
Primary outcomes will be measured using the Health Education Impact Questionnaire heiQ focusing on the skill and technique acquisition domain Secondary outcomes include other heiQ domains quality of life loneliness physical function pain intensity pain self-efficacy anxiety and depression fatigue patient global assessment disease activity and medication adherence Data will be collected at baseline 12 months and 18 months post-baseline
Discussion
This RCT will provide essential insights into the effectiveness of a targeted self-management intervention for patients newly diagnosed with IA The NISMA intervention developed following the Medical Research Council Framework for complex interventions aims to improve self-management skills and overall QoL By addressing the unique challenges faced by newly diagnosed patients this study seeks to enhance the initial management of IA aligning with the European Alliance of Associations for Rheumatology EULAR recommendations for self-management support If successful the NISMA intervention could represent a significant advancement in the non-pharmacological management of IA offering a comprehensive patient-centered approach that addresses both physical and psychological needs
Detailed Description:
Background
Inflammatory arthritis IA including rheumatoid arthritis RA psoriatic arthritis PsA and axial spondyloarthritis axSpA encompasses acute and chronic joint diseases characterized by joint pain swelling and tenderness due to inflammation IA affects over 2 of the global population with significant variability It can occur at any age and affects both sexes with an etiology involving genetic and lifestyle factors IA primarily causes joint pain and stiffness but can also impact other connective tissues Without adequate treatment IA can lead to functional decline irreversible joint damage comorbidities and increased mortality Early treatment with disease-modifying anti-rheumatic drugs DMARDs improves outcomes with about 60 of RA patients achieving long-term remission However symptoms may persist and fluctuate causing ongoing physiological and psychological distress impacting daily activities and quality of life QoL even in remission
Newly diagnosed patients with IA face particular challenges including regular blood tests lifelong medication side effects pain fatigue sleep disturbances and increased risk of comorbidities like depression and cardiovascular disease They often experience changes in body image family work and social life A crucial but often lacking aspect of IA care is empowering patients with a thorough understanding of their condition and effective self-management skills Studies show that newly diagnosed patients benefit from regular consultations and support from health professionals HPs to manage the physical emotional and social impacts of IA Enhanced self-management defined as the ability to manage symptoms treatments and lifestyle changes can improve QoL in chronic illness patients EULAR recommends incorporating self-management into daily rheumatology care including patient education and key approaches like problem-solving and action planning Despite this no IA-specific self-management interventions focused on newly diagnosed patients exist
Rationale
To address this gap the Newly diagnosed with Inflammatory arthritis - a Self-MAnagement intervention NISMA was developed Following the Medical Research Council MRC Framework 2930 for developing and evaluating complex interventions the researchers developed NISMA and tested its feasibility and fidelity Feedback from patients and HPs led to adjustments in session duration the number of sessions flexible scheduling recruitment strategies and inclusion criteria for axSpA patients Group sessions were made optional and more emphasis was placed on certain behavior change techniques
The hypothesis is that the adapted NISMA intervention will surpass usual care in enhancing self-management skills The next step is to test this hypothesis in a randomized controlled trial RCT If effective a cost-effectiveness analysis will be conducted
Objectives
The primary objective of this trial is to investigate the short-term efficacy of the NISMA intervention and usual care compared to usual care alone on self-management skills and techniques in patients newly diagnosed with inflammatory arthritis from baseline to completion of the intervention after 12 months
Our key secondary objectives are to compare the short-term efficacy of the NISMA intervention relative to usual care on self-management skills quality of life loneliness physical function pain intensity pain self-efficacy anxiety and depression fatigue patient global assessment disease activity C-reactive protein CRP and medication adherence from baseline to completion of the intervention after 12-months
Other objectives are to test the longer-term efficacy of the intervention relative to usual care on self-management skills quality of life loneliness physical function pain intensity pain self-efficacy anxiety and depression fatigue patient global assessment disease activity C-reactive protein CRP and medication adherence at follow-up 18-months after baseline
Trial design
The trial is designed as a multicenter pragmatic randomized trial with a two-group parallel design in a superiority framework Participants will be allocated in a 11 ratio after providing informed consent and completing baseline assessments they will be randomized to either the NISMA intervention experimental group or usual care control group with no protocolized treatment
Setting
Patients will be included from the following centers the Center for Rheumatology and Spine Diseases Rigshospitalet University Hospital Copenhagen and department of Rheumatology and Spine Diseases Holbæk Hospital both in Denmark
Sample size and power calculation
As no established thresholds exist for clinically relevant changes in heiQ domains we refer to prior research 6162 In the skills acquisition domain we found mean differences between groups ranging from 022 to 038 Therefore we decided that a minimal important difference probably corresponds to a target difference of 030 with a standard deviation SD of 055 for the heiQ skill and technique acquisition domain primary endpoint from baseline to 12 months after baseline To achieve a statistical power of 80 and a significance level set at an alpha of 005 our calculations indicated a need for 54 patients per group ie enrolling 108 patients in the ITT Population Incorporating an anticipated dropout rate of 15 from our feasibility study the sample size would correspond to 127 Consequently we revised the necessary sample size to approximately 65 patients per group ie 130 patients in the ITT population to achieve a reasonable statistical power to identify a statistically significant difference between the intervention and control group ie corresponding to a statistical power of 87 in the best-case scenario
Statistical Methods
Descriptive statistics for baseline data will be reported in a Table 1 format reported separately for each treatment group These descriptive statistics will summarize the characteristics of participants at baseline including demographic information and outcome variables relevant to the trial Descriptive statistics include the mean and standard deviation SD or median and interquartile ranges if applicable For categorical data we will report the count and percentages
The main analyses will be based on the Intention to Treat ITT population ie including all randomized patients with a baseline measure available 63 The ITT principle asserts the effect of a treatment policy that is the planned treatment regimen rather than the actual treatment given ie it is independent of treatment adherence 9 Accordingly participants allocated to a treatment group NISMA and Control respectively will be followed up assessed and analyzed as members of that group irrespective of their adherence to the planned course of treatment ie independent of withdrawals and cross-over phenomena
All 95 confidence intervals and P values will be two-sided We will not apply explicit adjustments for multiplicity rather we will analyze the key secondary outcomes and interpret these as endpoints in a prioritized order eg gatekeeping procedure The analyses of the secondary endpoints will be performed and interpreted in sequence until one of the analyses fails to show the statistically significant difference or until all analyses have been completed at a statistical significance level of 005 P005 All analyses in the statistical hierarchy will be based on the treatment policy estimand the primary estimand ie the ITT principle which quantifies the average treatment effect regardless of adherence to treatment or initiation of rescue interventions between baseline and month 12
The primary endpoint will be based on the change in heiQ from baseline to 12 after baseline estimated as the difference between least squares means In our main analyses estimations of between-group differences for all continuous outcomes will be conducted after 12 months
Continuous outcome measures will be analyzed using analysis of covariance with randomized treatment trial site and type of IA diagnoses as factors and baseline pre-exposure value as a covariate Categorical endpoints will be analyzed using logistic regression with the same factors and covariates A multiple imputation approach will be used in which missing data are imputed from month 12 measurements from participants in the same treatment group A series of complete data sets will be generated and analyzed and the results will be combined using the Rubin formula 64 to obtain overall estimates While binary outcomes will be analyzed and initially reported using Odds Ratios with 95confidence intervals 95CIs all between-group differences 95CIs for continuous outcomes will be based on the least-square means adjusted for baseline levels and stratifying factors to minimize random variation 65
Project Group
The project group includes two patient research partners professors in rheumatology nursing epidemiology and postdocs in occupational therapy and nursing They bring expertise in RCTs qualitative research and epidemiology
Patient Involvement
Three patients were involved in the initial design and development of the NISMA intervention During feasibility testing patients were interviewed to include their views A patient with RA serves as a research partner ensuring the patient perspective is maintained throughout the project 54
Dissemination and Protocol Amendments
Results will be disseminated through peer-reviewed journals academic conferences news outlets social media multimedia materials and popular science magazines Authorship will follow ICMJE guidelines Any significant protocol modifications will be communicated to the Committee on Health Research Ethics for The Capital Region of Denmark registered on ClinicalTrialsgov and detailed in the primary RCT report
Discussion
This trial addresses the need for targeted interventions for newly diagnosed IA patients By enhancing self-management skills early better long-term outcomes are anticipated The NISMA RCT aims to evaluate the effectiveness of a targeted self-management intervention Developed through a feasibility study and process evaluation the intervention is tailored to newly diagnosed patients and may prove more effective than previous interventions
The trial aligns with EULARs emphasis on high-quality systematic and personalized care in rheumatology Educating health professionals in group facilitation problem-solving goal-setting and cognitive-behavioral techniques could enhance multidisciplinary collaboration and patient satisfaction If effective a cost-effectiveness analysis will follow focusing on integrating the intervention into clinical practice
Limitations
The main limitations are the inability to blind participants potential spillover effects variability in usual care and the individually adjusted intervention content However outcome assessors will be blinded and participants will be instructed not to disclose their group
Inflammatory arthritis IA including rheumatoid arthritis RA psoriatic arthritis PsA and axial spondyloarthritis axSpA encompasses acute and chronic joint diseases characterized by joint pain swelling and tenderness due to inflammation IA affects over 2 of the global population with significant variability It can occur at any age and affects both sexes with an etiology involving genetic and lifestyle factors IA primarily causes joint pain and stiffness but can also impact other connective tissues Without adequate treatment IA can lead to functional decline irreversible joint damage comorbidities and increased mortality Early treatment with disease-modifying anti-rheumatic drugs DMARDs improves outcomes with about 60 of RA patients achieving long-term remission However symptoms may persist and fluctuate causing ongoing physiological and psychological distress impacting daily activities and quality of life QoL even in remission
Newly diagnosed patients with IA face particular challenges including regular blood tests lifelong medication side effects pain fatigue sleep disturbances and increased risk of comorbidities like depression and cardiovascular disease They often experience changes in body image family work and social life A crucial but often lacking aspect of IA care is empowering patients with a thorough understanding of their condition and effective self-management skills Studies show that newly diagnosed patients benefit from regular consultations and support from health professionals HPs to manage the physical emotional and social impacts of IA Enhanced self-management defined as the ability to manage symptoms treatments and lifestyle changes can improve QoL in chronic illness patients EULAR recommends incorporating self-management into daily rheumatology care including patient education and key approaches like problem-solving and action planning Despite this no IA-specific self-management interventions focused on newly diagnosed patients exist
Rationale
To address this gap the Newly diagnosed with Inflammatory arthritis - a Self-MAnagement intervention NISMA was developed Following the Medical Research Council MRC Framework 2930 for developing and evaluating complex interventions the researchers developed NISMA and tested its feasibility and fidelity Feedback from patients and HPs led to adjustments in session duration the number of sessions flexible scheduling recruitment strategies and inclusion criteria for axSpA patients Group sessions were made optional and more emphasis was placed on certain behavior change techniques
The hypothesis is that the adapted NISMA intervention will surpass usual care in enhancing self-management skills The next step is to test this hypothesis in a randomized controlled trial RCT If effective a cost-effectiveness analysis will be conducted
Objectives
The primary objective of this trial is to investigate the short-term efficacy of the NISMA intervention and usual care compared to usual care alone on self-management skills and techniques in patients newly diagnosed with inflammatory arthritis from baseline to completion of the intervention after 12 months
Our key secondary objectives are to compare the short-term efficacy of the NISMA intervention relative to usual care on self-management skills quality of life loneliness physical function pain intensity pain self-efficacy anxiety and depression fatigue patient global assessment disease activity C-reactive protein CRP and medication adherence from baseline to completion of the intervention after 12-months
Other objectives are to test the longer-term efficacy of the intervention relative to usual care on self-management skills quality of life loneliness physical function pain intensity pain self-efficacy anxiety and depression fatigue patient global assessment disease activity C-reactive protein CRP and medication adherence at follow-up 18-months after baseline
Trial design
The trial is designed as a multicenter pragmatic randomized trial with a two-group parallel design in a superiority framework Participants will be allocated in a 11 ratio after providing informed consent and completing baseline assessments they will be randomized to either the NISMA intervention experimental group or usual care control group with no protocolized treatment
Setting
Patients will be included from the following centers the Center for Rheumatology and Spine Diseases Rigshospitalet University Hospital Copenhagen and department of Rheumatology and Spine Diseases Holbæk Hospital both in Denmark
Sample size and power calculation
As no established thresholds exist for clinically relevant changes in heiQ domains we refer to prior research 6162 In the skills acquisition domain we found mean differences between groups ranging from 022 to 038 Therefore we decided that a minimal important difference probably corresponds to a target difference of 030 with a standard deviation SD of 055 for the heiQ skill and technique acquisition domain primary endpoint from baseline to 12 months after baseline To achieve a statistical power of 80 and a significance level set at an alpha of 005 our calculations indicated a need for 54 patients per group ie enrolling 108 patients in the ITT Population Incorporating an anticipated dropout rate of 15 from our feasibility study the sample size would correspond to 127 Consequently we revised the necessary sample size to approximately 65 patients per group ie 130 patients in the ITT population to achieve a reasonable statistical power to identify a statistically significant difference between the intervention and control group ie corresponding to a statistical power of 87 in the best-case scenario
Statistical Methods
Descriptive statistics for baseline data will be reported in a Table 1 format reported separately for each treatment group These descriptive statistics will summarize the characteristics of participants at baseline including demographic information and outcome variables relevant to the trial Descriptive statistics include the mean and standard deviation SD or median and interquartile ranges if applicable For categorical data we will report the count and percentages
The main analyses will be based on the Intention to Treat ITT population ie including all randomized patients with a baseline measure available 63 The ITT principle asserts the effect of a treatment policy that is the planned treatment regimen rather than the actual treatment given ie it is independent of treatment adherence 9 Accordingly participants allocated to a treatment group NISMA and Control respectively will be followed up assessed and analyzed as members of that group irrespective of their adherence to the planned course of treatment ie independent of withdrawals and cross-over phenomena
All 95 confidence intervals and P values will be two-sided We will not apply explicit adjustments for multiplicity rather we will analyze the key secondary outcomes and interpret these as endpoints in a prioritized order eg gatekeeping procedure The analyses of the secondary endpoints will be performed and interpreted in sequence until one of the analyses fails to show the statistically significant difference or until all analyses have been completed at a statistical significance level of 005 P005 All analyses in the statistical hierarchy will be based on the treatment policy estimand the primary estimand ie the ITT principle which quantifies the average treatment effect regardless of adherence to treatment or initiation of rescue interventions between baseline and month 12
The primary endpoint will be based on the change in heiQ from baseline to 12 after baseline estimated as the difference between least squares means In our main analyses estimations of between-group differences for all continuous outcomes will be conducted after 12 months
Continuous outcome measures will be analyzed using analysis of covariance with randomized treatment trial site and type of IA diagnoses as factors and baseline pre-exposure value as a covariate Categorical endpoints will be analyzed using logistic regression with the same factors and covariates A multiple imputation approach will be used in which missing data are imputed from month 12 measurements from participants in the same treatment group A series of complete data sets will be generated and analyzed and the results will be combined using the Rubin formula 64 to obtain overall estimates While binary outcomes will be analyzed and initially reported using Odds Ratios with 95confidence intervals 95CIs all between-group differences 95CIs for continuous outcomes will be based on the least-square means adjusted for baseline levels and stratifying factors to minimize random variation 65
Project Group
The project group includes two patient research partners professors in rheumatology nursing epidemiology and postdocs in occupational therapy and nursing They bring expertise in RCTs qualitative research and epidemiology
Patient Involvement
Three patients were involved in the initial design and development of the NISMA intervention During feasibility testing patients were interviewed to include their views A patient with RA serves as a research partner ensuring the patient perspective is maintained throughout the project 54
Dissemination and Protocol Amendments
Results will be disseminated through peer-reviewed journals academic conferences news outlets social media multimedia materials and popular science magazines Authorship will follow ICMJE guidelines Any significant protocol modifications will be communicated to the Committee on Health Research Ethics for The Capital Region of Denmark registered on ClinicalTrialsgov and detailed in the primary RCT report
Discussion
This trial addresses the need for targeted interventions for newly diagnosed IA patients By enhancing self-management skills early better long-term outcomes are anticipated The NISMA RCT aims to evaluate the effectiveness of a targeted self-management intervention Developed through a feasibility study and process evaluation the intervention is tailored to newly diagnosed patients and may prove more effective than previous interventions
The trial aligns with EULARs emphasis on high-quality systematic and personalized care in rheumatology Educating health professionals in group facilitation problem-solving goal-setting and cognitive-behavioral techniques could enhance multidisciplinary collaboration and patient satisfaction If effective a cost-effectiveness analysis will follow focusing on integrating the intervention into clinical practice
Limitations
The main limitations are the inability to blind participants potential spillover effects variability in usual care and the individually adjusted intervention content However outcome assessors will be blinded and participants will be instructed not to disclose their group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None