Multiple Sclerosis
Conditions
Keywords
multiple sclerosis, Fatigue, exercise, telemedicine, motivational interviewing, counseling, depression, physical activity
Brief summary
This is a clinical trial examining a brief motivational intervention to improve adherence to exercise among individuals with MS to improve fatigue.
Detailed description
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.
Interventions
BEHAVIORALBrief telephone-based counseling
Brief telephone-based counseling using Motivational Interviewing and physical activity goal setting and problem solving
OTHEREducation counseling
Mailed informational video of exercise programs
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Multiple Sclerosis * Veteran receiving services in VA VISN 20 * Fatigue * Ability to ambulate * cell phone or Household phone line * Individual with multiple sclerosis verified by MS provider * ambulatory
Exclusion criteria
* Current alcohol dependence or other substance dependence * No working phone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | baseline, 3 months, 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression | baseline, 3 months, 6 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity (Behavioral Target) | baseline, 3 months, 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Telephone Counseling Telephone based counseling and instructional video
Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving | 31 |
| Education Counseling Exercise information and instructional video
Informational video: Mailed video of exercise programs | 33 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Telephone Counseling | Education Counseling | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 3 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 30 Participants | 61 Participants |
| Age, Continuous | 52.7 years STANDARD_DEVIATION 11.6 | 53.6 years STANDARD_DEVIATION 13.1 | 53.1 years STANDARD_DEVIATION 12.3 |
| Race/Ethnicity, Customized Non-Hispanic, White | 27 participants | 26 participants | 53 participants |
| Race/Ethnicity, Customized Other | 4 participants | 7 participants | 11 participants |
| Region of Enrollment United States | 31 participants | 33 participants | 64 participants |
| Sex: Female, Male Female | 9 Participants | 14 Participants | 23 Participants |
| Sex: Female, Male Male | 22 Participants | 19 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 24 / 31 | 18 / 33 |
| serious Total, serious adverse events | 3 / 31 | 4 / 33 |
Outcome results
Primary
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
Population: Veterans with MS from Veterans Affairs (VA) Puget Sound Health Care System and civilians with MS from the greater Puget Sound area. Note: Telephone Counseling Group: 1=lost to follow-up, so analyzed 30 participants instead of 31.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telephone Counseling | Fatigue | Month 6 | 44.73 units on a scale | Standard Error 2.78 |
| Telephone Counseling | Fatigue | Baseline | 53.78 units on a scale | Standard Error 2.67 |
| Telephone Counseling | Fatigue | Month 3 | 45.76 units on a scale | Standard Error 3.01 |
| Education Counseling | Fatigue | Month 3 | 50.53 units on a scale | Standard Error 2.86 |
| Education Counseling | Fatigue | Month 6 | 49.70 units on a scale | Standard Error 2.65 |
| Education Counseling | Fatigue | Baseline | 49.65 units on a scale | Standard Error 2.54 |
p-value: 0.013ANOVA
p-value: 0.005ANOVA
p-value: 0.01ANOVA
Secondary
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
Population: Veterans with MS from Veterans Affairs (VA) Puget Sound Health Care System and civilians with MS from the greater Puget Sound area. Note: Telephone Counseling Group: 1=lost to follow-up, so analyzed 30 participants instead of 31.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telephone Counseling | Depression | Baseline | 11.38 units on a scale | Standard Error 0.99 |
| Telephone Counseling | Depression | Month 6 | 7.90 units on a scale | Standard Error 1.02 |
| Telephone Counseling | Depression | Month 3 | 9.55 units on a scale | Standard Error 1.08 |
| Education Counseling | Depression | Baseline | 10.54 units on a scale | Standard Error 0.95 |
| Education Counseling | Depression | Month 6 | 10.85 units on a scale | Standard Error 0.98 |
| Education Counseling | Depression | Month 3 | 10.86 units on a scale | Standard Error 1.03 |
p-value: 0.009ANOVA
p-value: 0.032ANOVA
Other Pre-specified
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
Population: Veterans with MS from Veterans Affairs (VA) Puget Sound Health Care System and civilians with MS from the greater Puget Sound area. Note: Telephone Counseling Group: 1=lost to follow-up, so analyzed 30 participants instead of 31.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telephone Counseling | Physical Activity (Behavioral Target) | Baseline | 16.37 units on a scale | Standard Error 3.54 |
| Telephone Counseling | Physical Activity (Behavioral Target) | Month 3 | 29.68 units on a scale | Standard Error 3.72 |
| Telephone Counseling | Physical Activity (Behavioral Target) | Month 6 | 31.06 units on a scale | Standard Error 3.19 |
| Education Counseling | Physical Activity (Behavioral Target) | Baseline | 14.79 units on a scale | Standard Error 3.37 |
| Education Counseling | Physical Activity (Behavioral Target) | Month 3 | 19.74 units on a scale | Standard Error 3.54 |
| Education Counseling | Physical Activity (Behavioral Target) | Month 6 | 15.43 units on a scale | Standard Error 3.04 |
p-value: 0.049ANOVA
p-value: 0.014ANOVA