Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603545
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
The Effect of Digital Education for Osteoporosis Patients on Fracture Risk and Related Health Outcomes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Digital Education for Osteoporosis Patients on Fracture Risk and Related Health Outcomes in Older Swedish Men and Women
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
A digital education for osteoporosis patients DEOP has been developed and tested on patients in Region Vastra Gotaland Sweden Currently the evidence regarding the efficacy of patient education on fracture risk medication adherence injurious falls levels of physical activity and diet is insufficient Most patients with osteoporosis in Sweden are diagnosed and treated in primary care where the knowledge about osteoporosis is often very limited Thus in general osteoporosis patients are not sufficiently informed before receiving a treatment recommendation This randomized controlled trial aims to investigate if DEOP vs standard care can reduce the incidence of fracture in older women and men and if the intervention leads to better adherence to osteoporosis medication higher quality of life increased physical activity and enhanced diet
The primary objective is to investigate if DEOP compared to standard care without DEOP can reduce the incidence of clinical fractures in men and women over the age of 65 years without previous osteoporosis medication the last year who have been recommended osteoporosis treatment after a DXA scan and assessment of clinical risk factors at an osteoporosis clinic
The secondary objectives are to investigate if DEOP compared to standard care without DEOP can reduce the incidence of injurious falls have positive effects on adherence to osteoporosis medication positively affect diet calcium and vitamin D intake physical activity and improve quality of life in men and women over the age of 65 years without previous osteoporosis medication the last year who have been recommended osteoporosis treatment after a DXA scan and assessment of clinical risk factors at an osteoporosis clinic
Study design randomized multicentre clinical trial Patients over the age of 65 visiting an osteoporosis unit for a bone density scan DXA will be asked to participate in the study The participants will be randomized to one of two arms where one arm will be invited to DEOP and the other arm will receive standard care without DEOP
The primary objective is to investigate if DEOP compared to standard care without DEOP can reduce the incidence of clinical fractures in men and women over the age of 65 years without previous osteoporosis medication the last year who have been recommended osteoporosis treatment after a DXA scan and assessment of clinical risk factors at an osteoporosis clinic
The secondary objectives are to investigate if DEOP compared to standard care without DEOP can reduce the incidence of injurious falls have positive effects on adherence to osteoporosis medication positively affect diet calcium and vitamin D intake physical activity and improve quality of life in men and women over the age of 65 years without previous osteoporosis medication the last year who have been recommended osteoporosis treatment after a DXA scan and assessment of clinical risk factors at an osteoporosis clinic
Study design randomized multicentre clinical trial Patients over the age of 65 visiting an osteoporosis unit for a bone density scan DXA will be asked to participate in the study The participants will be randomized to one of two arms where one arm will be invited to DEOP and the other arm will receive standard care without DEOP
Detailed Description:
The hypothesis is that improved patient education using an easily accessible online educational material will result in better adherence to osteoporosis medication and positive lifestyle changes which will lead to a lower risk of fractures and injurious falls The primary aim of this study is to investigate if a Digital Education for Osteoporosis Patients DEOP affects the risk of sustaining a clinical fracture in patients over the age of 65 who have been recommended osteoporosis treatment after a bone density DXA scan The secondary aims are to investigate if DEOP affects the risk of injurious falls adherence to osteoporosis medications improves dietary intake and quality of life and increases physical activity compared to standard care
The planned study is a multicentre randomized controlled trial with 9 participating study centers osteoporosis clinics Patients who have not previously received osteoporosis medication the last year and are over the age of 65 visiting an osteoporosis clinic for a clinical evaluation including a bone density scan DXA and assessment of clinical risk factors and fracture risk will be asked to participate in the study Before the appointment for the DXA measurement possible study participants will receive written information about the study by mail At the visit oral information about the study will be provided by the bone densitometry technologist Written information will be distributed to possible participants that have not previously received the information The patients must have the opportunity to ask questions before they make their decision to participate or not Acceptance to participate must be communicated both verbally and through signing an informed consent form All patients will undergo a DXA-scan and answer a questionnaire regarding clinical risk factors included in the fracture risk assessment tool FRAX according to local clinical guidelines
At a later stage if the patient by the doctor at the osteoporosis clinic is recommended pharmacological treatment for osteoporosis due to a high fracture risk the patient becomes eligible for the study If the patient does not have an indication to receive osteoporosis medication as judged by the physician at the osteoporosis unit the patient will be excluded from the study as screening failure and receive a notification of this through e-mail or regular mail
Patients eligible for the study will be randomized stratified according to sex and study center into one of two arms where patients in one arm will be invited to the DEOP and patients in the other arm will receive standard care without the DEOP Patients in both groups will be treated and followed according to clinical guidelines for osteoporosis care in their health care region by either a general practitioner GP or a doctor at an osteoporosis clinic Only osteoporosis clinics without an ongoing DEOP will be eligible as study clinics in these health care regions After randomization the local study coordinator will contact all included patients through e-mail or regular mail and ask them to complete self-reported questionnaires regarding physical activity diet and quality of life Physical Activity Scale for the Elderly PASE Food Frequency Questionnaire FFQ and quality of life Short Form survey SF-12 respectively Data regarding clinical risk factors and calculated 10-year probability of major osteoporotic fracture and hip fracture in the fracture risk assessment tool FRAX height and weight and bone mineral density BMD of the lumbar spine total hip and femoral neck in gramscm2 and as T-scores will be collected from the osteoporosis clinic by the local study coordinator or other study personnel After years 1 and 3 an e-mail or regular mail if the study participant does not use e-mail will be sent to the participants and they will be asked to answer the same questionnaires again Data regarding clinical fractures will be collected from the Patient Register Socialstyrelsen the National Board of Health and Welfare the Swedish Fracture Register and from regional X-ray archives after the end of the study maximum 4 years of follow-up Data on the incidence of injurious falls including injuries without fracture will be collected through the Patient Register at the end of the study Data on osteoporosis medication use will be collected from the Drug Dispensation Register and regional databases regarding medications provided at health care facilities at the end of the study Data on deaths will be collected using the National Cause of Death Register Data on diagnoses and medication will be collected five years back from the inclusion date to determine comorbidity
The participants in the DEOP group will be given access to the DEOP for four months after randomization Reminders will be sent out using phone text messages monthly for the first 3 months to participants who have not yet started the DEOP The control group will be given information regarding fall prevention physical activity diet and osteoporosis medication according to standard care by their GP or the physician at the osteoporosis clinics depending on where they are treated for their osteoporosis
The planned study is a multicentre randomized controlled trial with 9 participating study centers osteoporosis clinics Patients who have not previously received osteoporosis medication the last year and are over the age of 65 visiting an osteoporosis clinic for a clinical evaluation including a bone density scan DXA and assessment of clinical risk factors and fracture risk will be asked to participate in the study Before the appointment for the DXA measurement possible study participants will receive written information about the study by mail At the visit oral information about the study will be provided by the bone densitometry technologist Written information will be distributed to possible participants that have not previously received the information The patients must have the opportunity to ask questions before they make their decision to participate or not Acceptance to participate must be communicated both verbally and through signing an informed consent form All patients will undergo a DXA-scan and answer a questionnaire regarding clinical risk factors included in the fracture risk assessment tool FRAX according to local clinical guidelines
At a later stage if the patient by the doctor at the osteoporosis clinic is recommended pharmacological treatment for osteoporosis due to a high fracture risk the patient becomes eligible for the study If the patient does not have an indication to receive osteoporosis medication as judged by the physician at the osteoporosis unit the patient will be excluded from the study as screening failure and receive a notification of this through e-mail or regular mail
Patients eligible for the study will be randomized stratified according to sex and study center into one of two arms where patients in one arm will be invited to the DEOP and patients in the other arm will receive standard care without the DEOP Patients in both groups will be treated and followed according to clinical guidelines for osteoporosis care in their health care region by either a general practitioner GP or a doctor at an osteoporosis clinic Only osteoporosis clinics without an ongoing DEOP will be eligible as study clinics in these health care regions After randomization the local study coordinator will contact all included patients through e-mail or regular mail and ask them to complete self-reported questionnaires regarding physical activity diet and quality of life Physical Activity Scale for the Elderly PASE Food Frequency Questionnaire FFQ and quality of life Short Form survey SF-12 respectively Data regarding clinical risk factors and calculated 10-year probability of major osteoporotic fracture and hip fracture in the fracture risk assessment tool FRAX height and weight and bone mineral density BMD of the lumbar spine total hip and femoral neck in gramscm2 and as T-scores will be collected from the osteoporosis clinic by the local study coordinator or other study personnel After years 1 and 3 an e-mail or regular mail if the study participant does not use e-mail will be sent to the participants and they will be asked to answer the same questionnaires again Data regarding clinical fractures will be collected from the Patient Register Socialstyrelsen the National Board of Health and Welfare the Swedish Fracture Register and from regional X-ray archives after the end of the study maximum 4 years of follow-up Data on the incidence of injurious falls including injuries without fracture will be collected through the Patient Register at the end of the study Data on osteoporosis medication use will be collected from the Drug Dispensation Register and regional databases regarding medications provided at health care facilities at the end of the study Data on deaths will be collected using the National Cause of Death Register Data on diagnoses and medication will be collected five years back from the inclusion date to determine comorbidity
The participants in the DEOP group will be given access to the DEOP for four months after randomization Reminders will be sent out using phone text messages monthly for the first 3 months to participants who have not yet started the DEOP The control group will be given information regarding fall prevention physical activity diet and osteoporosis medication according to standard care by their GP or the physician at the osteoporosis clinics depending on where they are treated for their osteoporosis
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