Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00223457
Status:
COMPLETED
Last Update Posted:
2007-01-25
First Post:
2005-09-15
Brief Title:
Factors That Influence Compliance With Disease-Modifying Therapy in Multiple Sclerosis
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Factors That Influence Compliance With Disease-Modifying Therapy in Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2005-04
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:
The purpose of this study is to evaluate the coorelation between patient factors health care provider factors drug factors and compliance in patients with relapsing forms of multiple sclerosis RMS treated with Disease Modifying Agents DMA We hypothesize that a number of factors influence compliance with DMAs
Detailed Description:
While compliance rates with interferons and glatiramer acetate treatment have been high when assessed in the context of controlled clinical trials we have observed substantially less consistent rates of drug administration in general practice Correspondingly the magnitude of drug efficacy achieved on clinical and surrogate markers of disease activity in the latter patient group may be compromised compared to patients participating in controlled clinical trials Further in many circumstances the perception of breakthrough disease simply constitutes treatment noncompliance
The National Multiple Sclerosis Society reports only 50 of all MS patients and 60 with relapsing remitting MS are taking disease modifying agents in the US Zwibel 2003 A number of studies have investigated this challenging issue When glatiramer acetate therapy was specifically evaluated the investigators found several factors to be associated with compliance They discovered adherence to be higher with the patient perception of physician support of the medication prescribed patient sense of control higher levels of hope and no previous use of other disease modifying therapy Fraser Hadjimichael and Vollmer 2001 Another study by Hadjimichael and Vollmer 1999 surveyed patients for reasons that medications were discontinued Disease progression lack of improvement and side effects were some of the reasons reported by patients for stopping disease-modifying therapy
Depression is another factor found to impact adherence Mohr Goodkin Likosky Gatto Baumann and Rudick 1997 saw increased rates of compliance with Interferon beta-1b therapy in multiple sclerosis with the treatment of underlying depression The study showed that patients with increased depression were more likely to discontinue therapy This link of depression has also been demonstrated with noncompliance with antihypertensive medications WangBohn Harooni et al 2002 In another study Mohr 2001 saw patients experienced level of anxiety with their injections was related to adherence
We hypothesize that a number of factors influence compliance with DMAs these include
1 Patient factors
1 Perceived quality of life
2 Empowerment sense of control hope
3 Support structure family faith injection assistance etc
4 Depression
5 Fatigue
6 Cognitive problems
7 Perception of drug efficacy benefit over costs
2 Physician HCP support factors
1 Patients perception of MD support
2 Relationship with MD
3 Access to nurses and other HCP support functions
4 Services provided by physicianclinical practice ie academic community-based or MS clinic
5 Adequate education on MS establishing reasonable expectations concerning the benefit derived from therapy
3 Drug factors
1 complexity of drug administration
2 drug associated side effectstolerability
3 Perceived MS symptom control
4 Insurance coverage of the injection
5 Concomitant medications
Once the factors that contribute to noncompliance to DMA therapies are identified healthcare professionals can evaluate how they can be impacted The healthcare team can work towards addressing those barriers where there is a possibility for change to help improve patient outcomes
The primary objective of this study is to evaluate the correlation between patient factors HCP support factors drug factors and compliance in patients with relapsing forms of multiple sclerosis RMS treated with Disease Modifying Agents DMA
The secondary objectives of the study are to determine differences in patient compliance between patients treated by academic centersMS specialists and community neurology centers and to determine the factors that impact this difference
Patients are asked to sign electronic agreement a consent to participate in this confidential study when they initially log-on to the study website Patients are assigned a unique identification number when they log into the internet for the first time to complete the study survey By using this assigned number health information will be protected for each individual Patient names will be used only for purposes of check distribution and participation in following studies if the patient consents If a patient drops out of the study TNS Healthcare will contact the patient to find out the reason The treating physician does not know who elected to participate in the study
Study Design- This is a multicenter retrospective trial administered through patient surveys We are utilizing the validated MS quality of life 54 MSQOL-54 the Becks Fast Screen for medical patients the Hope Herth Index and a patient self-reported drug compliance survey The participating neurologists were asked to give patients with relapsing forms of MS flyers describing the study The flyers direct patients to the designated study website to complete the confidential survey by internet As described below patients log-on to the website a total of 3 times during the study period Baseline time 0 Month 1 Time 1 and Month 2 Time 2 Patients log on with a unique identification number rather than names to ensure that confidentiality is maintained throughout the study
The goal is to have an equal number of patients treated with the four different DMAs AVONEX Rebif Copaxone and Betaseron The sample is to include at least 150-200 patients from each of the MS Centers and 15-20 patients from each of the community sites for a total of approximately 1040 patients Power analysis was performed assuming a 15 critical effect value The sample size was calculated to provide 80 power to detect the critical effect value at a confidence interval of 95 Response rates are estimated to be 60 for the first wave and 75 for the second wave of questionnaires
The National Multiple Sclerosis Society reports only 50 of all MS patients and 60 with relapsing remitting MS are taking disease modifying agents in the US Zwibel 2003 A number of studies have investigated this challenging issue When glatiramer acetate therapy was specifically evaluated the investigators found several factors to be associated with compliance They discovered adherence to be higher with the patient perception of physician support of the medication prescribed patient sense of control higher levels of hope and no previous use of other disease modifying therapy Fraser Hadjimichael and Vollmer 2001 Another study by Hadjimichael and Vollmer 1999 surveyed patients for reasons that medications were discontinued Disease progression lack of improvement and side effects were some of the reasons reported by patients for stopping disease-modifying therapy
Depression is another factor found to impact adherence Mohr Goodkin Likosky Gatto Baumann and Rudick 1997 saw increased rates of compliance with Interferon beta-1b therapy in multiple sclerosis with the treatment of underlying depression The study showed that patients with increased depression were more likely to discontinue therapy This link of depression has also been demonstrated with noncompliance with antihypertensive medications WangBohn Harooni et al 2002 In another study Mohr 2001 saw patients experienced level of anxiety with their injections was related to adherence
We hypothesize that a number of factors influence compliance with DMAs these include
1 Patient factors
1 Perceived quality of life
2 Empowerment sense of control hope
3 Support structure family faith injection assistance etc
4 Depression
5 Fatigue
6 Cognitive problems
7 Perception of drug efficacy benefit over costs
2 Physician HCP support factors
1 Patients perception of MD support
2 Relationship with MD
3 Access to nurses and other HCP support functions
4 Services provided by physicianclinical practice ie academic community-based or MS clinic
5 Adequate education on MS establishing reasonable expectations concerning the benefit derived from therapy
3 Drug factors
1 complexity of drug administration
2 drug associated side effectstolerability
3 Perceived MS symptom control
4 Insurance coverage of the injection
5 Concomitant medications
Once the factors that contribute to noncompliance to DMA therapies are identified healthcare professionals can evaluate how they can be impacted The healthcare team can work towards addressing those barriers where there is a possibility for change to help improve patient outcomes
The primary objective of this study is to evaluate the correlation between patient factors HCP support factors drug factors and compliance in patients with relapsing forms of multiple sclerosis RMS treated with Disease Modifying Agents DMA
The secondary objectives of the study are to determine differences in patient compliance between patients treated by academic centersMS specialists and community neurology centers and to determine the factors that impact this difference
Patients are asked to sign electronic agreement a consent to participate in this confidential study when they initially log-on to the study website Patients are assigned a unique identification number when they log into the internet for the first time to complete the study survey By using this assigned number health information will be protected for each individual Patient names will be used only for purposes of check distribution and participation in following studies if the patient consents If a patient drops out of the study TNS Healthcare will contact the patient to find out the reason The treating physician does not know who elected to participate in the study
Study Design- This is a multicenter retrospective trial administered through patient surveys We are utilizing the validated MS quality of life 54 MSQOL-54 the Becks Fast Screen for medical patients the Hope Herth Index and a patient self-reported drug compliance survey The participating neurologists were asked to give patients with relapsing forms of MS flyers describing the study The flyers direct patients to the designated study website to complete the confidential survey by internet As described below patients log-on to the website a total of 3 times during the study period Baseline time 0 Month 1 Time 1 and Month 2 Time 2 Patients log on with a unique identification number rather than names to ensure that confidentiality is maintained throughout the study
The goal is to have an equal number of patients treated with the four different DMAs AVONEX Rebif Copaxone and Betaseron The sample is to include at least 150-200 patients from each of the MS Centers and 15-20 patients from each of the community sites for a total of approximately 1040 patients Power analysis was performed assuming a 15 critical effect value The sample size was calculated to provide 80 power to detect the critical effect value at a confidence interval of 95 Response rates are estimated to be 60 for the first wave and 75 for the second wave of questionnaires
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