University of Michigan - East Ann Arbor Geriatrics Center
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT06624163
The purpose of the present pilot is to evaluate the outcomes of adding a patient coach to support the Optimal Health Weight and Lifestyle (OHWL) Clinic plan developed by PI Dewar, specifically to address barriers and facilitators of adherence to the plan. This will be accomplished via a coach who is not embedded in clinic care and is supported by pilot research funds. Evaluation of the coach activities, conducted by research personnel, will include compiling data from the electronic health record, a short set of patient report and performance measures, and qualitative interviews.
Looking for future studies?
Notify Me60 year–85 year
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
A patient coach added to the OHWL Clinic plan as part of the pilot will help patients who are being treated for weight loss to achieve their goals, help address barriers and facilitators of adherence to referred services such physical therapy and nutritionist appointments and various specialists and links to community services as needed. Evaluation of the coach activities will be conducted by research personnel, which will also include data compilation from the electronic health record, a short set of patient report and performance measures, and qualitative interviews. This project will provide pilot data for future funding proposals.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Following a directed history and physical at the initial visit, the OHWL Care provider (OCP) develops a medical and weight management plan, which includes laboratory testing (such as for Hemoglobin A1C (HbA1c), consultant referrals (e.g. sleep, heart failure clinics) and referral to nutritionists and physical therapy (PT). The OCP begins the process of establishing patient goals, which will be followed up by the coach. The OCP reviews patient progress with the goals during face-to-face visits (some by telehealth) at two, four and six months. As part of the standard initial clinic evaluation, a medical assistant evaluates grip strength (using a hand dynamometer) the timed up and go mobility test; these are repeated at the 6-month visit.
A patient coach follows patients outside of clinic to ensure adherence with referral appointments and use of recommended community services. The coach assesses the participant at baseline, 3 months, and 6 months using the Patient-Specific Functional Scale and follows up with patients via phone over 6 months. The coach utilizes S.M.A.R.T. (Specific, Measurable, Achievable, Relevant, Time-bound) goals to facilitate, for example, transportation, barriers to scheduling, etc. The coach follows up on specialist referral recommendations, physical therapy, and nutrition program, as well as social work recommendations. Barriers and facilitators to program adherence are identified and addressed.
Time frame: 6 months
Patients who reported attending at least one physical therapy appointment during the course of the study, if referred.
Time frame: 6 months
Percentage of participants whose coaches reported successful achievement of established goals for diet and physical therapy based on end of study interview.
Time frame: 6 months
Patients who reported attending at least one nutritional consultation appointment during the course of the study.
Time frame: 6 months
Patients who reported using a community resource (such as a gym, community park, or other similar resource) at least once during the course of the study.
Time frame: 6 months
PROMIS 29 questionnaire gauges health-related quality of life across seven key domains: physical function, pain interference, fatigue, sleep disturbance, physical and mental health, and social health. Each item is auto-scored and T-score is obtained for each domain and will be tracked during the study time frame
Scores range from 0 to 100, where a score of 0 indicates lowest quality of life and 100 indicates highest quality of life.
Time frame: 6 months
This is assessed by PROMIS-Global Pain instrument which is a survey administered to patient by Computer adaptive testing, Scale 0-10 (where 0 is no pain and 10 is worst pain imaginable) and will track change during study period
Time frame: 6 months
NHATS instrument scores individual's self-report of difficulty or dependency with performing activities of daily living such as self-care and mobility and restrictions in instrumental activities of daily living domains. Each domain has multiple questions with responses such as (Yes/No) for most; (None, little, some, Lot); (Always did it by self, together with someone else, someone always did it, it varied, not done in the last month); (everyday, most days, some days, rarely, never); (every time, most times, sometimes, rarely).
Time frame: 6 months, 12 months
Mobility and balance is measured during clinic visits using TUG (Timed up and go). The patient is asked to rise from a seated position, walk 3 m, turn around, and return and sit in the starting point chair while timed. Patients who fail to complete the test in fewer than 12 s are considered to have elevated fall risk Measurements will be taken every six months.
Time frame: 6 months
Life-space mobility is a measure of resilience to physical decline and social isolation in older adults. They are nine 'yes/no' questions regarding a person's movements across nine life-space zones in the preceding 3 days. The total score ranges from 0 to 9, where 0 means most restricted life-space and 9 is least restricted life-space.
Time frame: 6 months
The Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool is a web-based tool that enables multiple, automatically coded self-administered 24-hour recalls. Participants are asked to report everything they ate or drank over the last 24-hours by using an online tool. Data collected on enrollment and 3 months and at 6 months. Intake of grams fat will be tracked to see changes over the study period.
Time frame: 6 months
The Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool is a web-based tool that enables multiple, automatically coded self-administered 24-hour recalls. Participants are asked to report everything they ate or drank over the last 24-hours by using an online tool. Data collected on enrollment and 3 months and at 6 months. Intake of total kilocalories will be tracked to see changes over the study period.
Time frame: 6 months
The Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool is a web-based tool that enables multiple, automatically coded self-administered 24-hour recalls. Participants are asked to report everything they ate or drank over the last 24-hours by using an online tool. Data collected on enrollment and 3 months and at 6 months. Intake of grams saturated fat will be tracked to see changes over the study period.
Time frame: 6 months
The Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool is a web-based tool that enables multiple, automatically coded self-administered 24-hour recalls. Participants are asked to report everything they ate or drank over the last 24-hours by using an online tool. Data collected on enrollment and 3 months and at 6 months. Intake of milligrams sodium will be tracked to see changes over the study period.
Time frame: 6 months
The Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool is a web-based tool that enables multiple, automatically coded self-administered 24-hour recalls. Participants are asked to report everything they ate or drank over the last 24-hours by using an online tool. Data collected on enrollment and 3 months and at 6 months. Intake of grams of added sugar will be tracked to see changes over the study period.
Time frame: 6 months
The Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool is a web-based tool that enables multiple, automatically coded self-administered 24-hour recalls. Participants are asked to report everything they ate or drank over the last 24-hours by using an online tool. Data collected on enrollment and 3 months and at 6 months. Intake of grams of alcohol will be tracked to see changes over the study period.
University of Michigan
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05742165
Behavior, Body Weight
New York, United States
View Trial DetailsNCT05882045
Body Weight, Cardiovascular Diseases
Phoenix, Arizona, United States
View Trial DetailsNCT05929079
Apnea, Body Weight
Anniston, Alabama, United States
View Trial DetailsNCT00342732
Body Weight, Nutrition Disorders
Phoenix, Arizona, United States
View Trial Details