Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05872633
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2023-03-30
Brief Title:
Online Self-management in Hand Osteoarthritis
Sponsor:
Leiden University
Organization:
Leiden University Medical Center
Study Overview
Official Title:
An Online Self-management Intervention for Patients With Hand Osteoarthritis - a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-05
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:
NB This study has been previously registered with the National Trial Registry NTR6266 that has been cancelled The registered trial has been automatically transferred to a new Landelijk Trial Register which does not contain all correct information on the current study and where no corrections can be made Hence the current study has been registered again with ClinicalTrialsgov
The goal of this clinical trial is to study the effectiveness of an online self-management intervention in adult patients with hand osteoarthritis and to explore the possibilities to implement the intervention in clinical practice after the study period An RCT will be performed in which 70 participants will be randomized to either care-as-usual hand osteoarthritis care path including consultation with the rheumatologist and a 15-hour consultation with a clinical nurse or occupational therapist n35 or care-as-usual plus the online self-management intervention n35 The primary effect constitutes of the difference in change in pain coping between patients in the intervention and control condition from baseline to post-intervention As secondary outcomes a number of other psychological and physical outcome measures will be assessed eg health-related quality of life well-being pain impact on daily life pain cognitions Also cost-effectiveness of the intervention will be measured by assessing productivity loss and health care use of participants using iPCQ and iMCQ
The goal of this clinical trial is to study the effectiveness of an online self-management intervention in adult patients with hand osteoarthritis and to explore the possibilities to implement the intervention in clinical practice after the study period An RCT will be performed in which 70 participants will be randomized to either care-as-usual hand osteoarthritis care path including consultation with the rheumatologist and a 15-hour consultation with a clinical nurse or occupational therapist n35 or care-as-usual plus the online self-management intervention n35 The primary effect constitutes of the difference in change in pain coping between patients in the intervention and control condition from baseline to post-intervention As secondary outcomes a number of other psychological and physical outcome measures will be assessed eg health-related quality of life well-being pain impact on daily life pain cognitions Also cost-effectiveness of the intervention will be measured by assessing productivity loss and health care use of participants using iPCQ and iMCQ
Detailed Description:
Rationale Hand osteoarthritis has a high clinical burden as reflected by considerable pain decreased strength and mobility physical disability and an often-decreased health-related quality of life Self-management factors related to physical and psychosocial adjustment such as patients perceptions about their disease and coping play an important role in heath-related quality of life and functional ability in patients with chronic diseases such as osteoarthritis Improving capacities of patients in managing a chronic condition is increasingly recognized as important in the treatment of somatic conditions and is becoming more common in clinical practice and research In this study the effect of an online self-management intervention focusing on coping skills related to chronic pain in comparison to care-as-usual is studied
Objective To study the effectiveness of the online self-management intervention in patients with hand osteoarthritis and to explore the possibilities to implement the intervention in clinical practice after the study period
Study design An RCT will be performed in which 70 participants will be randomized to either care-as-usual hand osteoarthritis care path including consultation with the rheumatologist and a 15-hour consultation with a clinical nurse or occupational therapist n35 or care-as-usual plus the online self-management intervention n35 Baseline post-intervention 6-week and three-month follow-up questionnaires will be used to measure primary and secondary outcomes To assess implementation possibilities of the online intervention structured qualitative interviews among patients and health professionals will examine to what extent the intervention suits the needs and skills of patients and to what extent the intervention fits within the current care process
Study population All patients 18 years with hand osteoarthritis who are referred to the hand osteoarthritis care path at the rheumatology clinic at Leiden University Medical Center with on-going pain complaints during at least three months will be invited to participate in the study Patients need to be fluent in Dutch need to be able to give informed consent and have internet access Severe psychiatric co-morbidity on-going psychological treatment elsewhere difficulties with written communication a lack of internet literacy and having secondary osteoarthritis are exclusion criteria
Intervention The intervention is based on cognitive-behavioral methods It starts off with a face-to-face introduction consultation Subsequently the tailored self- management intervention will be offered via an online program The intervention consists of six modules containing pain education practical assignments relaxation training and registrations The first and last modules are an introductory and closure module in between are four modules aimed at learning how to cope with the consequences of a chronic condition in daily life The modules focus on 1 activity 2 mood 3 thoughts and 4 the social environment At least once a week participants receive feedback on the assignments and motivational support from a psychologist by means of text messages in a secured mail box in the online program After finishing the online program patients will be approached by their treating psychologist for two booster sessions via telephone In these booster sessions it will be evaluated how the patient further attained hisher pre-set goals for the intervention Strategies to strengthen the achieved results will be discussed The booster sessions will take place 1 month and 25 months after finishing the online program
Main study parametersendpoints The primary effect constitutes of the difference in change in pain coping between patients in the intervention and control condition from baseline to post-intervention As secondary outcomes a number of other psychological and physical outcome measures will be assessed eg health-related quality of life well-being pain impact on daily life pain cognitions Also cost-effectiveness of the intervention will be measured by assessing productivity loss and health care use of participants using iPCQ and iMCQ
Nature and extent of the burden and risks associated with participation benefit and group relatedness In the control group the usual standard of care is provided In the intervention group patients will be offered an internet-based self-management intervention which potentially improves their pain coping and other psychological and physical outcomes No risk is involved with participation in this study The only burden for participants is investment of time
Objective To study the effectiveness of the online self-management intervention in patients with hand osteoarthritis and to explore the possibilities to implement the intervention in clinical practice after the study period
Study design An RCT will be performed in which 70 participants will be randomized to either care-as-usual hand osteoarthritis care path including consultation with the rheumatologist and a 15-hour consultation with a clinical nurse or occupational therapist n35 or care-as-usual plus the online self-management intervention n35 Baseline post-intervention 6-week and three-month follow-up questionnaires will be used to measure primary and secondary outcomes To assess implementation possibilities of the online intervention structured qualitative interviews among patients and health professionals will examine to what extent the intervention suits the needs and skills of patients and to what extent the intervention fits within the current care process
Study population All patients 18 years with hand osteoarthritis who are referred to the hand osteoarthritis care path at the rheumatology clinic at Leiden University Medical Center with on-going pain complaints during at least three months will be invited to participate in the study Patients need to be fluent in Dutch need to be able to give informed consent and have internet access Severe psychiatric co-morbidity on-going psychological treatment elsewhere difficulties with written communication a lack of internet literacy and having secondary osteoarthritis are exclusion criteria
Intervention The intervention is based on cognitive-behavioral methods It starts off with a face-to-face introduction consultation Subsequently the tailored self- management intervention will be offered via an online program The intervention consists of six modules containing pain education practical assignments relaxation training and registrations The first and last modules are an introductory and closure module in between are four modules aimed at learning how to cope with the consequences of a chronic condition in daily life The modules focus on 1 activity 2 mood 3 thoughts and 4 the social environment At least once a week participants receive feedback on the assignments and motivational support from a psychologist by means of text messages in a secured mail box in the online program After finishing the online program patients will be approached by their treating psychologist for two booster sessions via telephone In these booster sessions it will be evaluated how the patient further attained hisher pre-set goals for the intervention Strategies to strengthen the achieved results will be discussed The booster sessions will take place 1 month and 25 months after finishing the online program
Main study parametersendpoints The primary effect constitutes of the difference in change in pain coping between patients in the intervention and control condition from baseline to post-intervention As secondary outcomes a number of other psychological and physical outcome measures will be assessed eg health-related quality of life well-being pain impact on daily life pain cognitions Also cost-effectiveness of the intervention will be measured by assessing productivity loss and health care use of participants using iPCQ and iMCQ
Nature and extent of the burden and risks associated with participation benefit and group relatedness In the control group the usual standard of care is provided In the intervention group patients will be offered an internet-based self-management intervention which potentially improves their pain coping and other psychological and physical outcomes No risk is involved with participation in this study The only burden for participants is investment of time
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