Table 3.
Details of home-based measures
| Method | Measure | LHR Protocol | Challenges |
|---|---|---|---|
| Interactive voice response (IVR) telephonic survey system twice daily for 7 days | Psychosocial experiences and exposures | LHR taught participants to respond to telephonic surveys about mood, stressors, and diabetes, twice daily for 7 days. | Participant burden; questions seem repetitive; needing a quiet place to answer phone survey; too busy to answer phone |
| The IVR survey was offered in English or Spanish. CHWs reviewed each question with participants who then practiced answering surveys. A cheat sheet was made available with easy-to-read instructions and pictures. CHWs called the participants several times over the 7 days to promote adherence to the protocol, answer questions, and resolve any problems. Participants were provided the phone number of the CHW to contact in case of any difficulties. Study cell phone and headphones were loaned to participants. | |||
| 24-h urine sample | Urine protein and catecholamine levels | LHR taught participants to collect and store a 24-hour urine sample that LHR picked up and transported to the university for analysis. | Forgetting; unpleasant; urinating while away from home; not wanting to store urine in the refrigerator |
| Participants were given “hats” in which to urinate on the toilet and a bottle to collect their urine for 24 hours. The bottle required refrigeration in a cooler chest. A cheat sheet was made available with easy-to-read instructions and pictures. | |||
| Continuous glucose monitor for 7 days | Interstitial glucose measured every 5 minutes | LHR instrumented participants with a CGM and de-instrumented them after 7 days. A supervisor transferred the electronic data file to the university. | Fear of insertion; forgetting to calibrate; discomfort of sensor insertion; itching/discomfort at the insertion site; unpleasant in hot months and many participants have no air conditioning |
| Medtronic Minimed Gold (Northridge, CA) CGM detects levels from 40 to 400 md/dL in the interstitial tissue via sensor to a monitor every 10 s. Participants were blinded to CGM glucose readings to minimize reactivity. LHR inserted the sensor under the skin and trained participants how to calibrate it twice daily for 7 days. LHR phone calls reminded participants to calibrate and to troubleshoot. Participants were also given a pictorial guide and LHR phone numbers for difficulties. A cheat sheet was made available with easy-to-read instructions and pictures. | |||
| Holter monitor for 24 hours | 24-hour heart rate variability | LHR instrumented participants with a Holter monitor, de-instrumented them after 24 hours, and a supervisor transferred electronic data file to the university. | Itching/discomfort at electrode site; participant burden wearing the monitor and leads; no shower for 24 h; unpleasant in hot months and many participants have no air conditioning |
| 7-lead, 3-channel ambulatory electrodcardiograms were used. LHR prepped skin and then instrumented participants with 7-lead, 3-channel ambulatory ECG monitors (Holters). GE Medical (Milwaukee, WI) Marquette Series 8500 direct (amplitude-modulated) recorders. A cheat sheet was made available with easy-to-read instructions. Participants were de-instrumented after 24 hours. Outcome was the standard deviation of the normal-to-normal R-R interval). | |||
| Sit-to-stand blood pressure | Autonomic function. | LHR took digital blood pressure and recorded values in REDCap. | Protocol demands precision from LHR; need for quiet place to lie down |
| The participant’s blood pressure is measured with a digital sphygmomanometer by Ormron (Kyoto, Japan) while lying down, and again after standing up unaided. The postural falling blood pressure is taken as the difference in systolic blood pressure exactly 4 minutes after standing. Outcome is the Difference between the baseline supine and the minimal BP after standing up. | |||
| Handgrip blood pressure | Autonomic function. | The maximum voluntary contraction is first determined using a handgrip dynamometer. Handgrip is then maintained at 30% of that maximum for as long as possible, up to 5 minutes. BP is measured three times before and at 1-minute intervals during handgrip. The outcome is the difference between diastolic during handgrip and mean of 3 baseline diastolics. | Protocol demands precise timing from LHR; low participant motivation due to hand/wrist discomfort |
| Actigraphy for 7 days | Physical activity and sedentary behavior | LHR instrumented participants with two accelerometers, one worn on the hip and one on the wrist. After 7 days, LHR de-instrumented participants and a supervisor transferred electronic data file to the university. | Participant burden and forgetting; accelerometer should not get wet |
| A tri-axial accelerometer (Actigraph GT3X, Actigraph) was worn for 7 days on the hip using an elastic belt or clip. Data collected at 80 Hz were downloaded (Actilife software, v6.13.3, Actigraph). Activity counts were analyzed at the minute level from the vertical axis of the device. Classification of activity was determined using cut-points to categorize minutes in sedentary behavior, light activity, and moderate-to-vigorous physical activity. | |||
| Actigraphy for 7 days | Sleep | For the same seven days, participants wore an accelerometer (Actiwatch Spectrum Plus; Philips-Respironics, Murrysville, PA) on the non-dominant wrist. Outcomes included mean nighttime total sleep time (TST), mean nighttime wake after sleep onset, standard deviation of 24-h TST, and standard deviation of sleep timing (clock-hour midpoint for nighttime sleep). | Participant burden and forgetting |
| Hair cortisol | Chronic stress | LHR collected, packaged, and labeled hair samples and shipped them to the university for processing. | Participant concerns about esthetics and appearance |
| LHR collected a hair sample (1 cm, ∼ 1month of growth) from approximately 2 cm below the cranial bone. | |||
| Surveys | Trauma symptoms | LHR administered surveys verbally and recorded responses in REDCap. | LHR discomfort asking, and participant distress responding to, items regarding trauma and hardship. |
| 16-item Harvard Trauma symptom questionnaire, 13 items from the baksbat questionnaire, 1 item regarding kmoach sangkhat, 4 questions regarding history of starvation, and the 6-item food security survey. |
CALMS-D = community health workers assisting latinos manage stress and diabetes; CGM = continuous glucose monitor; DREAM = diabetes risk reduction through eat, walk, sleep, and medication therapy management; IVR = interactive voice response; LHR = lay health research personnel; REDCap = Remote electronic data capture.
For example: “on a 3-point scale (1= “not at all” to 3 = “a lot”) did you …have pain, numbness, or tingling in your hands, legs or feet?.” Participants who did not own their own phone were provided study phones. All were provided headsets to facilitate hands-free keypad responding. Participants were provided with a “cheat sheet” of response options. IVR reporting windows were set for 8-10 AM and 8-10 PM. The IVR system called participants at random times during these 2-hour windows. If the call was unanswered, the system continued calling regularly within the time window. Participants could use a keypad response to indicate that they should be called back in 15 minutes. Postponed calls were permitted until the end of the reporting window after which the report was coded as missing.