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Table 1 Data collection measures instruments

From: HOME DM-BAT: home-based diabetes-modified behavioral activation treatment for low-income seniors with type 2 diabetes—study protocol for a randomized controlled trial

Measure

Method

Primary outcomes

 Hemoglobin A1C

Blood specimens will be obtained at baseline and at 3, 6, 9, and 12 months.

 Blood pressure

Blood pressure readings will be obtained by study nurses using automated BP monitors (OMRON IntelliSenseTM HEM-907XL). The device will be programmed to take 3 readings at 2-min intervals and give an average of the 3 BP readings.

 LDL - cholesterol

Blood specimens will be obtained at baseline and at 3, 6, 9, and 12 months.

Secondary outcomes

 Behavioral skills (SDSCA)

This will be assessed with the Summary of Diabetes Self-Care Activities (SDSCA) scale [47], a brief, validated self-report questionnaire of diabetes self-care.

 Medication adherence

This will be measured with the 6-item validated self-report Brooks Medication Adherence Scale (BMAS) [48].

 Resource utilization/cost

Previously validated questions that capture information on hospitalizations, physician visits, professional visits, and medications will be used.

 Quality of life (SF-12)

The SF-12 [49] is a valid and reliable instrument to measure functional status and reproduces 90% of the variance in PCS-36 and MCS-36 scores.

 Quality adjusted life years (EQ-5D)

The EQ-5D is a validated measure to assess health status developed by the EuroQol group and assess health status across 5 dimensions using 26 items [50].

Social determinants

 Financial resources

Financial resources will be measured using 7 items previously validated by Behavioral Risk Factor Surveillance System [51] regarding the social context in which a respondent lives.

 Housing insecurity

Housing insecurity will be based on a series of 6 questions developed by Columbia University to measure the full spectrum of instability in housing over one year [52].

 Food insecurity

6-item scale classifies household food security status and is valid for households with and without children [53]

 Perceived stress

The perceived stress scale (PSS) is a 4-item scale that assesses the degree to which the respondent finds situations stressful [54].

 Coping

Coping will be assessed using the 8-item emotional approach coping measure to allow evaluation of emotional processing and emotional expression [55].

 Perceived discrimination

Previously validated items from the DISTANCE survey [56] will be used to capture perceived discrimination.

 Adverse childhood experiences

The Adverse Childhood Experiences scale is a 10-item scale that assesses the degree to which the respondent experienced childhood maltreatment [57].

 Competing needs

This will be assessed by validated questions that capture the impact of competing subsistence needs on healthcare [58].

Covariates

 Patient demographics

Previously validated items from the National Health Interview Survey will be used to capture demographic characteristics.

 Social support

The Medical Outcomes Study (MOS) Social Support Survey [59] will be used to measure social support.

 Health literacy

A 3-item literacy scale noting capacity to obtain, process, and understand basic health-related decisions will measure health literacy [60].

 Depression (Patient Health Questionnaire – 9 – PHQ-9)

This will be assessed by the validated 9-item PHQ-9 [61].

 Medical comorbidity (chronic health conditions—BRFSS)

This will be assessed using previously validated items from the Behavioral Risk Factor Surveillance System [62].