Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to investigate if the investigators can improve physical activity and social participation level among Veterans with diabetes.
Physical activity is the cornerstone of good diabetes management, and yet effective physical activity intervention is not available. The investigators developed a lifestyle intervention based on individual's home activity patterns. The goal of the study is to test the efficacy of this intervention among Veterans with diabetes in a randomized-controlled trial. In addition to physical activity, the investigators will also assess if the intervention will improve social participation among Veterans.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | OT-led counseling based on home activity pattern |
|
| Wait-listed | Placebo Comparator | Usual activity during the study. At the end of the study, will receive OT-led counseling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Counseling | Behavioral | OT led counseling |
| |
| Usual education |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity | Home physical activity changes from baseline to 6-months.Physical activity was measured using a validated survey called CHAMPS, asking the participants to report activities that they participated in a typical week, such as walking, doing house work, dancing, etc. | 6 months |
| Social Participation | Survey questionnaires of participation change from baseline to 6-months follow up, specifically, satisfaction with participation in social roles, satisfaction with participation in discretionary social activities, and ability to participate in social roles and activities. Each survey has been validated and scored on the T-score metrics. A T-score is a standardized score, and has a "middle" score; it is 50 for T-scores. This middle score is the mean of a large sample that is representative of the US general population. The survey results are T-score metrics in which 50 is the mean score of the general population and 10 is the standard deviation (SD) of that population. The study outcomes are changes in T-scores of each survey from baseline to 6-months follow-up, where positive score means improved outcome, and negative score means worse outcome at 6-months. | 6 months |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Physical Function | Six month changes in timed up and go test, where the participant get up from sitting in a chair, walk meters, turn around, and walk back to sit down. Positive changes means worse outcome for timed up and go (seconds). | 6 months |
| Physical Function |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pearl G. Lee, MD | VA Ann Arbor Healthcare System, Ann Arbor, MI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan | 48105 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | OT-led counseling based on home activity pattern Counseling: OT led counseling |
| FG001 | Wait-listed | Usual activity during the study. At the end of the study, will receive OT-led counseling Usual education: At the end of the study, will receive OT-led counseling |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One participant was identified to not have diabetes diagnosis after consent, therefore, no baseline data collected on this participant and s/he was not included in further analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | OT-led counseling based on home activity pattern Counseling: OT led counseling |
| BG001 | Wait-listed | Usual activity during the study. At the end of the study, will receive OT-led counseling Usual education: At the end of the study, will receive OT-led counseling |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Physical Activity | Home physical activity changes from baseline to 6-months.Physical activity was measured using a validated survey called CHAMPS, asking the participants to report activities that they participated in a typical week, such as walking, doing house work, dancing, etc. | Only participants who completed the home monitoring activities were included in the outcomes analysis. | Posted | Mean | Standard Deviation | KCal/week | 6 months |
|
For each participant, the adverse event data were collected from the beginning of the enrollment until the last follow up visit, up to 6-months final follow up visit, or when the participant withdrew from the study. For the wait-list group, the participants may complete the OT-intervention up to one month after the 6-months follow-up visit, thus the total follow up period may be 7 months.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | OT-led counseling based on home activity pattern Counseling: OT led counseling |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor , possibly study related adverse events | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Muscle sprain, knee pain |
The study participants are predominantly male and are all veterans, so the results would be difficult to be generalized to female and non-veterans. Physical activity is measured by a survey, which may have recall bias.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pearl Lee, MD | VA Ann Arbor | 734-845-3182 | Pearl.Lee2@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2015 | Oct 25, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Behavioral |
At the end of the study, will receive OT-led counseling |
|
Six month changes in gait speed, which is the comfortable gait peed in 10 meter walking. Positive changes means better outcomes for gait speed (meters per second). |
| 6 months |
| Physical Function | Six month changes in six-minute walk test, which measures the distance a participant walked at usual pace for six minutes. Positive changes means better outcomes for six-minute walk (meters). | 6 months |
| Participant did not have diabetes |
|
| Did not complete home monitoring activities after baseline visit |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Primary | Social Participation | Survey questionnaires of participation change from baseline to 6-months follow up, specifically, satisfaction with participation in social roles, satisfaction with participation in discretionary social activities, and ability to participate in social roles and activities. Each survey has been validated and scored on the T-score metrics. A T-score is a standardized score, and has a "middle" score; it is 50 for T-scores. This middle score is the mean of a large sample that is representative of the US general population. The survey results are T-score metrics in which 50 is the mean score of the general population and 10 is the standard deviation (SD) of that population. The study outcomes are changes in T-scores of each survey from baseline to 6-months follow-up, where positive score means improved outcome, and negative score means worse outcome at 6-months. | Only participants with completed surveys were included in the analysis. | Posted | Mean | Standard Deviation | T-score | 6 months |
|
|
|
|
| Other Pre-specified | Physical Function | Six month changes in timed up and go test, where the participant get up from sitting in a chair, walk meters, turn around, and walk back to sit down. Positive changes means worse outcome for timed up and go (seconds). | Only participants who completed the 6-months physical function assessment were included in the analysis. | Posted | Mean | Standard Deviation | seconds | 6 months |
|
|
|
|
| Other Pre-specified | Physical Function | Six month changes in gait speed, which is the comfortable gait peed in 10 meter walking. Positive changes means better outcomes for gait speed (meters per second). | Only participants who completed the 6-months physical function assessment were included in the analysis. | Posted | Mean | Standard Deviation | meter per second | 6 months |
|
|
|
|
| Other Pre-specified | Physical Function | Six month changes in six-minute walk test, which measures the distance a participant walked at usual pace for six minutes. Positive changes means better outcomes for six-minute walk (meters). | Only participants who completed the 6-months physical function assessment were included in the analysis. | Posted | Mean | Standard Deviation | meters | 6 months |
|
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 2 |
| 52 |
| EG001 | Wait-listed Without OT-Led Counseling | Usual activity during the study. At the end of the study, will receive OT-led counseling Usual education | 0 | 52 | 0 | 52 | 0 | 52 |
| EG002 | Wait-listed With OT-Led Counseling | Usual activity during the study. At the end of the study, will receive OT-led counseling Counseling: At the end of the study, will receive OT-led counseling | 0 | 52 | 0 | 52 | 1 | 52 |
|
| Minor, possibly study related adverse events | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | A fall under unclear circumstances and did not need to seek medical care |
|
| Minor, possibly related to the study | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | toe nail bleed may be related to walking |
|
Not provided
Not provided
| D001519 | Behavior |
| D005159 | Health Care Facilities Workforce and Services |
| Satisfaction discretionary social roles |
|
|
| Ability to participate social roles and activities |
|
|
| Mixed Models Analysis |
| 0.57 |
| Slope |
| -1.02 |
| 2-Sided |
| 95 |
| -4.53 |
| 2.48 |
| Superiority |
| We hypothesized that at the end of 6 months, intervention group will have improved participation as measured by the survey on the ability to participate in social roles and activities. | Mixed Models Analysis | 0.12 | Slope | -2.44 | 2-Sided | 95 | -5.52 | 0.63 | Superiority |