Boston Rehabilitative Impairment Study of the Elderly (Boston RISE), 2009-2015 (ICPSR 37045)

Time Period(s) View help for Time Period(s)

Date of Collection View help for Date of Collection

Study Purpose View help for Study Purpose

The purpose of this study was to fill the knowledge gap regarding predictors for mobility decline.

Study Design View help for Study Design

The study visits were designed to collect extensive information on medical and rehabilitative impairments according to the aims of the study. An effort was made to evaluate all relevant attributes while also keeping subject burden manageable. During the first baseline visit, a nurse practitioner and a research assistant obtained informed consent and conducted the final eligibility screening. If the participant screened into the study, the nurse practitioner conducted the baseline visit, which generally required 2.5 hours including informed consent. This assessment included a physical examination, medical history, medication inventory, demographics, neuropsychological testing, and questionnaires on pain. The second baseline visit, which was conducted by a research assistant, took place within 2 weeks of the first visit and generally required 2 hours. This assessment included physical performance testing and questionnaires on functional ability, falls, rehabilitative care, and physical activity. Participants received $20 for each baseline visit. Transportation to both visits using commercial wheelchair-accessible vans was provided for all participants as needed. Follow-up assessments were conducted at 12 and 24 months at Spaulding Rehabilitation Hospital Cambridge and used the same 2-visit structure. Between each set of visits, study staff contacted participants by phone every 3 months for a brief interview tracking falls, hospitalizations, emergency department visits, and rehabilitative care. Recruitment was initiated in December 2009 and was completed in January 2012.

Sample View help for Sample

Study recruitment targeted adults aged 65 years or older living within a 10-mile radius from and who were receiving primary care at Massachusetts General Hospital (MGH) or Brigham and Women's Hospital (BWH). Study staff used the Research Patient Data Registry (RPDR) to generate primary care provider specific lists of patients meeting the preliminary eligibility criteria. The RPDR is a centralized clinical data registry housing clinical information from Partners HealthCare facilities. Patients meeting the preliminary inclusion criteria within a provider's panel were randomly selected for inclusion on the recruitment master list. The master list was divided into subgroups based on sex, age, and race, and sorted into a random order to ensure random selection from each subgroup. Screening samples of 50 to 100 patients were created and sent to each provider for review. Oversampling did occur within the sample lists with regard to race, age, and sex to ensure recruitment of a cohort representative of the older adult population living within the recruitment catchment area. The providers received the screening sample by e-mail and were asked to respond within 1 week to corroborate eligibility. Study staff sent a reminder e-mail to nonresponding providers after 1 week. Participating practices were given posters and brochures to display in waiting areas so interested patients could contact study staff directly.

Potential participants approved for contact were sent either a single letter signed by the provider and the principal investigator (for MGH patients) or 2 letters signed separately by the provider and the principal investigator (for BWH patients). The letters described the study and included a postage-paid postcard to return to decline participation. The letters stated that study staff would try to contact patients by phone if there was no response within 2 weeks. Study staff made up to 7 attempts to reach potential participants by phone.

During the initial phone contact, study staff performed an eligibility screening. To be included, participants had to (1) be age 65 or older (2) be able to understand and communicate in English and (3) have difficulty or task modification with walking one-half mile (6 blocks) or climbing 1 flight (10 steps) of stairs. Study staff also asked questions to determine the presence of major medical problems that would interfere with safe completion of the study protocol: significant visual impairment, uncontrolled hypertension, lower extremity amputation, supplemental oxygen use, and myocardial infarction or major surgery in the previous 6 months. Study participation was limited to English speakers because it was not feasible to translate the study instruments and conduct the interviews in the many other languages spoken in the Boston area.

Individuals who expressed interest in participating and met eligibility criteria were scheduled for the 2 baseline visits. Final eligibility was determined at the first visit. Researchers excluded persons with a Mini-Mental State Exam score of less than 18, which indicated moderate or severe cognitive impairment. Researchers also excluded persons scoring less than 4 on the Short Physical Performance Battery (SPPB), which indicated existing disability. To ensure a broad distribution of baseline physical functioning, researchers used the SPPB score to group prospective enrollees based on mobility performance. Researchers excluded individuals scoring 11 or 12 (maximum score) on the SPPB once the preselected threshold was reached.

Participants from the original sample were invited to participate in the extension and the ancillary studies.

Time Method View help for Time Method

Universe View help for Universe

Adults aged 65 years or older living within a 10-mile radius from and who were receiving primary care at Massachusetts General Hospital or Brigham and Women's Hospital in Boston.

Unit(s) of Observation View help for Unit(s) of Observation

Data Type(s) View help for Data Type(s)

Mode of Data Collection View help for Mode of Data Collection

Description of Variables View help for Description of Variables

Dataset 1 (Main Data File) contains 1,290 cases and 246 variables. The data file includes demographic variables such as education, marital status, and gender. There are scores derived from administered instruments such as the Mini Mental State Exam (MMSE), the Short Physical Performance Battery (SPPB), and the Hopkins Verbal Learning Test (HVLT). There are several variables asking respondents if they have certain health problems such as heart disease, hypertension, or lung disease. Respondents were also asked about their history of smoking and falls. Pain was measured using the Brief Pain Inventory (BPI) and the McGill Pain Map. Additionally, scores derived from the Late Life Function and Disability Instrument (LLFDI) and the Patient Health Questionnaire (PHQ-9) are included. Lastly, there are measures of physical ability and characteristic scores such as range of motion, coordination, endurance, and body mass index (BMI).

Dataset 2 (Falls and Rehabilitation Follow-Up Years 0-2) contains 4,273 cases and 13 variables. The variables pertain to recent falls, hospital stays, rehabilitative care, and emergency room visits.

Dataset 3 (Medications) contains 10,293 cases and 9 variables. The variables relate to medications taken by respondents such as name, strength, route, and number taken. There are also variables for the Iowa Drug Information Service drug name and number.

Dataset 4 (Tracking) contains 430 cases and 7 variables. The variables include the participant's status at Years 1 to 4 and provides a reason if the participant missed a visit or left the study.

Dataset 5 (Falls and Rehabilitation Follow-Up Years 3-4) contains 1,846 cases and 14 variables. The variables pertain to recent falls, hospital stays, and emergency room visits.

Dataset 6 (Fall Injury Medical Record) contains 6,550 cases and 90 variables. The variables pertain to recent falls, fall injuries, type and severity of fall injuries, emergency room visits, and hospitalization dates.

Dataset 7 (Imputed Impairments Year 0) contains 43,000 cases and 10 variables. The variables include measurements of physical ability such as extension and strength of trunk, legs, and joints.

Dataset 8 (Imputed Impairments Year 1) contains 43,000 cases and 14 variables. The variables include measurements of physical ability such as extension and strength of trunk, legs, and joints.

Dataset 9 (Imputed Impairments Year 2) contains 43,000 cases and 14 variables. The variables include measurements of physical ability such as extension and strength of trunk, legs, and joints.

Dataset 10 (Late Life Function and Disability Instrument (LLFDI)) contains 610 cases and 17 variables. The variables include scores based on ability to perform basic tasks such as walking and climbing stairs.

Dataset 11 (Mobility Assessment Tool: Short Form (MAT-SF)) contains 632 cases and 15 variables. The variables measure self-perception of physical ability for tasks such as walking, jogging, and climbing stairs.

Dataset 12 (Definitive Symptomatic Lumbar Spinal Stenosis (SLSS)) contains 1,275 cases and 18 variables. The variables measure symptoms of Lumbar Spinal Stenosis (LSS) such as leg pain, numbness, or weakness.

Dataset 13 (CT Scan Measurements - Abdominal Cavity and Vertebral Height) contains 49 cases and 13 variables. The variables measure cross sectional area and width of the abdominal cavity at different vertebral levels as well as vertebral height of individual vertebra.

Dataset 14 (CT Scan Measurements - Lumbar Muscle) contains 4,861 cases and 11 variables. The variables include measurements of position and area of scans made at 3 lumbar slices at different vertebral levels.

Dataset 15 (CT Scan Measurements - Thigh Muscle) contains 816 cases and 11 variables. The variables include measurements of position and area of a scanned mid-thigh slice.

Response Rates View help for Response Rates

Of 7,403 primary patients identified using the Research Patient Data Registry (RPDR), 5,333 (72 percent) were approved by primary care providers to receive communication about the study. Recruitment letters were received by 4,495 people and 47 people independently contacted study staff after seeing recruitment materials in primary care offices or hearing about the study from a family member or friend. Among 1,349 people who had phone screenings, 712 (56 percent) met eligibility for the final screening at the clinic study site. Informed consent was given by 523 people, and 443 (85 percent) met eligibility criteria for continuation in the study. Out of those, 430 (96 percent) completed both baseline visits.

Presence of Common Scales View help for Presence of Common Scales

The study utilized the following:

• Avlund Mobility-Tiredness Scale
• Frailty and Injuries Cooperative Studies of Intervention Techniques (FICSIT)
• Hopkins Verbal Learning Test
• Late Life Function and Disability Instrument (LLFDI)
• McGill Pain Map
• Mini-Mental State Exam (MMSE)
• Patient Health Questionnaire-9 (PHQ-9)
• Semmes-Weinstein Monofilament Test
• Short Physical Performance Battery (SPPB)
• Snellen Vision Test
• Mobility Assessment Tool: Short Form (MAT-SF)

Original Release Date View help for Original Release Date

2018-05-31

Version History View help for Version History