An interventional study of Brief telephone-based counseling and Education counseling in Multiple Sclerosis, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-10-09.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
This is a clinical trial examining a brief motivational intervention to improve adherence to exercise among individuals with MS to improve fatigue.
This is a 2-arm single blind parallel group RCT comparing a brief telephone based motivational intervention to an informational control to improve adherence to exercise among individuals with MS. The primary outcome is improvement in fatigue.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 64 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Telephone based counseling and instructional video
Behavioral: Brief telephone-based counseling
Mailed Physical Activity information and instructional video only
Other: Education counseling
Brief telephone-based counseling using Motivational Interviewing and physical activity goal setting and problem solving
Mailed informational video of exercise programs
Fatigue
Modified Fatigue Inventory Scale (MFIS) at baseline, 3-month, 6-month MFIS consisted of 21 items, ranging from 0 (never) to 4 (almost always). The total score was 0 to 84.
Time frame: baseline, 3 months, 6 months
Depression
Depression Module of the Patient Health Questionnaire (PHQ-9). 9-item self-report instrument designed to identify depressive symptoms consistent with criteria for major depressive episode in the Diagnostic and Statistical Manual for Mental Disorders, 4th Edition. Each item is rated over the last 2 weeks: 0 (not at all), 1 (several days), 2 (more than half the days), or 3 (nearly every day). Total Score for 9 items = 27.
Time frame: baseline, 3 months, 6 months
Physical Activity (Behavioral Target)
First item of the Godin Leisure-Time Exercise Questionnaire (GLTEQ). GLTEQ asks participants to indicated the number of days per week they engaged in strenuous (e.g., running), moderate (e.g., easy bicycling), and mild (e.g., easy walking) exercise activities for periods of 15 min or more. Total weekly frequency is then calculated using an algorithm that multiplies the frequency of activities by 9 (strenuous), 5 (moderate), or 3 (mild) metabolic equivalents and sums each to produce a total level of physical activity in MET/min per week.
Time frame: baseline, 3 months, 6 months
| Milestone | Telephone Counseling | Education Counseling |
|---|---|---|
| Started | 31 | 33 |
| Completed | 30 | 33 |
| Not completed | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
Modified Fatigue Inventory Scale (MFIS) at baseline, 3-month, 6-month MFIS consisted of 21 items, ranging from 0 (never) to 4 (almost always). The total score was 0 to 84.
| units on a scale | Telephone Counseling | Education Counseling |
|---|---|---|
| Baseline | 53.78 ± 2.67 | 49.65 ± 2.54 |
| Month 3 | 45.76 ± 3.01 | 50.53 ± 2.86 |
| Month 6 | 44.73 ± 2.78 | 49.70 ± 2.65 |
Depression Module of the Patient Health Questionnaire (PHQ-9). 9-item self-report instrument designed to identify depressive symptoms consistent with criteria for major depressive episode in the Diagnostic and Statistical Manual for Mental Disorders, 4th Edition. Each item is rated over the last 2 weeks: 0 (not at all), 1 (several days), 2 (more than half the days), or 3 (nearly every day). Total Score for 9 items = 27.
| units on a scale | Telephone Counseling | Education Counseling |
|---|---|---|
| Baseline | 11.38 ± 0.99 | 10.54 ± 0.95 |
| Month 3 | 9.55 ± 1.08 | 10.86 ± 1.03 |
| Month 6 | 7.90 ± 1.02 | 10.85 ± 0.98 |
First item of the Godin Leisure-Time Exercise Questionnaire (GLTEQ). GLTEQ asks participants to indicated the number of days per week they engaged in strenuous (e.g., running), moderate (e.g., easy bicycling), and mild (e.g., easy walking) exercise activities for periods of 15 min or more. Total weekly frequency is then calculated using an algorithm that multiplies the frequency of activities by 9 (strenuous), 5 (moderate), or 3 (mild) metabolic equivalents and sums each to produce a total level of physical activity in MET/min per week.
| units on a scale | Telephone Counseling | Education Counseling |
|---|---|---|
| Baseline | 16.37 ± 3.54 | 14.79 ± 3.37 |
| Month 3 | 29.68 ± 3.72 | 19.74 ± 3.54 |
| Month 6 | 31.06 ± 3.19 | 15.43 ± 3.04 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Telephone Counseling | — | 3/31 (9.7%) | 24/31 (77.4%) |
| Education Counseling | — | 4/33 (12.1%) | 18/33 (54.5%) |
| Event | Telephone Counseling | Education Counseling |
|---|---|---|
| MS exacerbationNervous system disorders | 1/31 | 2/33 |
| car accident not related to studyCardiac disorders | 1/31 | 0/33 |
| FallMusculoskeletal and connective tissue disorders | 1/31 | 0/33 |
| Overnight hospital stay - 24 hour observation of first dose of FingolimodNervous system disorders | 0/31 | 1/33 |
| Routine Overnight Inpatient Hospital Stay for MS EvaluationNervous system disorders | 0/31 | 1/33 |
| Event | Telephone Counseling | Education Counseling |
|---|---|---|
| FallNervous system disorders | 6/31 | 3/33 |
| Suicidal ideationPsychiatric disorders | 4/31 | 5/33 |
| PainMusculoskeletal and connective tissue disorders | 3/31 | 1/33 |
| FatigueNervous system disorders | 2/31 | 3/33 |
| Increased MS SymptomsNervous system disorders | 2/31 | 0/33 |
| MS exacerbationNervous system disorders | 2/31 | 2/33 |
| muscle soreness from exerciseMusculoskeletal and connective tissue disorders | 2/31 | 0/33 |
| NumbnessNervous system disorders | 2/31 | 1/33 |
| Cut ThumbInjury, poisoning and procedural complications | 1/31 | 0/33 |
| ulcerGastrointestinal disorders | 1/31 | 0/33 |
Participants were individuals with MS recruited through (a) outpatient clinics at Veterans Affairs (VA) Puget Sound Health Care System, (b) targeted mailings to veterans in the VA MS National Data Repository who lived within the state of Washington, and (c) non-VA community-based MS support groups in the greater Puget Sound area.
| Age, Categorical(Participants) | Telephone Counseling | Education Counseling | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 31 | 30 | 61 |
| >=65 years | 0 | 3 | 3 |
| Age, Continuous(years) | Telephone Counseling | Education Counseling | Total |
|---|---|---|---|
| Mean | 52.7 ± 11.6 | 53.6 ± 13.1 | 53.1 ± 12.3 |
| Sex: Female, Male(Participants) | Telephone Counseling | Education Counseling | Total |
|---|---|---|---|
| Female | 9 | 14 | 23 |
| Male | 22 | 19 | 41 |
| Race/Ethnicity, Customized(participants) | Telephone Counseling | Education Counseling | Total |
|---|---|---|---|
| Non-Hispanic, White | 27 | 26 | 53 |
| Other | 4 | 7 | 11 |
| Region of Enrollment(participants) | Telephone Counseling | Education Counseling | Total |
|---|---|---|---|
| United States | 31 | 33 | 64 |
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Plan to share: No
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