Trial Outcomes & Findings for The Cherokee Study: Cherokee Health for Elderly Residents With Osteoarthritis of the Knee (NCT NCT04946344)

The Cherokee Study: Cherokee Health for Elderly Residents With Osteoarthritis of the Knee

Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) pain subscale in overweight and obese adults with knee OA compared to an attention-control group - The pain index assesses participants' pain on the same scale, ranging from 0 (none) to 4 (extreme). The pain subscale consists of 5 items. Normalized values are reported. To calculate, the mean score of the individual items of is divided by 4 (the highest possible score for a single answer option). The mean of the observed items is then multiplied by 100 and subtracted from 100. Total scores can range from 0-100, with larger scores indicating greater pain.

Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) function subscale in overweight and obese adults with knee OA compared to an attention-control group - participants indicate on a scale from 0 (none) to 4 (extreme) the degree of difficulty experienced in the last week due to knee OA. Scores range from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status. The higher the score, the poorer the function.

The physical dimension of the SF-36 is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. A higher score represents a more favorable health state.

To determine whether a pragmatic, community-based, 3-month, diet-induced weight-loss and exercise intervention improves 6-minute walk distance (an accepted measure of mobility) in overweight and obese adults with knee OA compared to an attention control group.

A score lower than 10 indicates one or more mobility limitations. A score lower than 10 is predictive of all-cause mortality

A score lower than 10 indicates one or more mobility limitations. A score lower than 10 is predictive of all-cause mortality

A score lower than 10 indicates one or more mobility limitations. A score lower than 10 is predictive of all-cause mortality

Ascending and descending stair activity measured by the time (in seconds) it takes to ascend and descend a flight of 8 steps with 20cm (8 inch) step height

Evaluates the generic quality of life developed in Europe and widely used. The EuroQol Quality (EQ)-five dimensions (5D) descriptive system is a preference-based Health-related quality of life (HRQL) measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression

Duration is a measure to determine participants' beliefs in their physical capability to successfully complete incremental 5-minute intervals (5 to 40 minutes) at a moderately fast pace For each item, participants indicate their confidence to execute the behavior on a 100-point percentage scale comprised of 10-point increments, ranging from 0% (not at all confident) to 100% (highly confident). Total strength for each measure of self-efficacy is then calculated by summing the confidence ratings and dividing by the total number of items in the scale, resulting in a maximum possible efficacy score of 100

Measures both positive and negative affect, leading to more insightful outlooks regarding participants' feeling states. This scale consists of 20 items that reflect the intensity of how the participant "feels" right now

Will ask the participants' confidence in performing certain activities

Focused to assess global life satisfaction - Participants indicate how much they agree or disagree with each of the 5 items using a 7-point scale that ranges from 7 strongly agree to 1 strongly disagree

A 20-item measure employed to assess self-efficacy for weight management - 10-point Likert scale ranging from 0 (not confident) to 9 (very confident) to resist the desire to eat.

Will measure the degree to which people perceive their lives as stressful - PSS-10 scores are obtained by reversing the scores on the four positive items: For example, 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4, 5, 7, and 8 are the positively stated items. Scores around 13 are considered average. Higher scores indicate higher stress.

Assess beliefs in one's ability (confidence) to continue exercising at various intensities and frequencies - This 12-item scale assessed patient confidence to carry out important treatment-related behaviors related to adhering to treatment plans, including medication regimen adherence and following plans for nutrition, exercise, etc, in the face of barriers - Higher scores indicate a greater level of self-efficacy

People are asked to indicate the degree to which they have the above thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is yielded (ranging from 0-52), along with three subscale scores assessing rumination, magnification and helplessness

The KOOS questionnaire will be used to assess the patient's opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury and also consequences of primary osteoarthritis (OA) - the mean score of the individual items of each subscale and divide by 4 (the highest possible score for a single answer option). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems

The ICOAP assesses pain in individuals with knee osteoarthritis taking into account both constant and intermittent pain experiences - the 11 items are scored from 0-4 with 0 being no pain and 4 being extreme pain - maximum score = 100

The diet history method is a detailed retrospective dietary assessment which obtains details of individual foods, and comprehensive information about foods eaten less regularly

The BRFSS is a cross-sectional telephone survey that measures health literacy - the nation's premier system of health-related telephone surveys that collect state data about U.S. residents regarding their health-related risk behaviors, chronic health conditions, and use of preventive services.

The PASE assesses the types of activities typically chosen by older adults (walking, recreational activities, exercise, housework, yard work, and caring for others. It uses frequency, duration, and intensity level of activity over the previous week to assign a score, ranging from 0 to 793, with higher scores indicating greater physical activity -Total PASE scores are computed by multiplying activity weights by activity frequencies

During the MOCA, a health professional asks a patient a series of questions designed to test a range of everyday mental skills. The maximum MOCA score is 30 points. A score of 20 to 24 suggests mild dementia, 13 to 20 suggests moderate dementia, and less than 12 indicates severe dementia

The score is the sum of the 20 questions. Possible range is 0-60. If more than four questions are missing answers, do not score the Center for Epidemiologic Studies Depression (CES-D) questionnaire. A score of 16 points or more is considered depressed

Resource utilization will be collected by questionnaire, with domains including visits to clinicians (physicians, nurses, physical therapists, others), tests, medications, injections, surgery, alternative therapies. The Work Productivity and Activity Impairment index (WPAI) will be used to assess absenteeism and reduced productivity while at work