Table 2.
Summary of Descriptive and Secondary Endpoint Measures and Testing Occasions
| Domain (purpose) | Measure (Citation/ Source) | Description (alpha based on previous trials) | Respondent | Testing Occasion |
|---|---|---|---|---|
| PwD cognitive status (descriptive, possible covariate) | MMSE (Folstein, 1999) | Cognitive status | PwD | Screening process |
| PwD physical health and comorbidities (descriptive, possible covariate) | Caregiver assessment of function (CAFU).(Gitlin, 2005) | CG proxy report of PwD dependence level (a little to complete help) (alpha =.90) | Caregiver | Screening process |
| PwD Quality of life as rated by CG (secondary outcome) | QOL-AD (Logsdon, 2002) | 12 domains; PwD with MMSE>10 can respond; also proxy report is used | Caregiver | T1, T2, T3 |
| Demographics (descriptive, possible covariate) | Caregiver and PwD Information (US Census + other sources) | Basic background characteristics | Caregiver | T1 |
| Medications (descriptive, possible covariate) | PwD and CG medications (Adapted from REACH) | Brown bag review of prescription and non-prescription meds | Brown bag review | T1 |
| PwD physical health (descriptive, possible covariate) | SF-36, other health measures | CG Proxy report of health | Caregiver | T1 |
| CG Objective and subjective burden (secondary outcomes) | -Upset with behaviors (NPI-C);burden;(Bedard, 2001) Vigilance Items (Hrs. on duty + doing things)(Mahoney, 2003) | For each NPI-C behavior, CG rates upset (0=no upset to 4=very upset); Vigilance items ask CG to estimate time spent in care (alpha = .89) | Caregiver | T1, T2, T3 T1, T2, T3 |
| CG Depressive symptoms (potential moderator) | CES-D short form179,(Santor, 1997)188 | 10-items; sensitive to change; Cut off for depression ≥8 (alpha = .91) | Caregiver | T1, T2, T3 |
| CG Skill acquisition (secondary outcome) | Task Management Strategies Index (Gitlin, 2002)87 | Frequency using simplification techniques. Likert scale (1= never use to 5 = always use) (alpha = .80) | Caregiver | T1, T2, T3 |
| CG Efficacy (secondary outcome) | Caregiver confidence using activities (Gitlin, 2008)86 | 5 items reported on a 10 point scale (0=Not confident, 10=Very confident). | Caregiver | T1, T2, T3 |
| Activity use and CG use of discretionary time (exploratory outcome) | Investigator developed(Gitlin, 2008)86,92 | Track use of prescribed activities in treatment arm | Caregiver | Telephone survey following T3 |
| Treatment implementation - Delivery; Receipt Enactment (description of intervention processes) | Intervention Delivery Assessment form Investigator developed (adapted from REACH and refined in pilot work) | a) dose (# of contacts); b) intensity (time spent each contact); c) session content; d) CG acceptability (receipt) and perceived benefit (enactment; e) acceptability (receipt) and perceived benefit and activity use (enactment) | Interventionist | Interventionist completes within 48 hrs. of each |
| Evaluation of study/ Quality control (descriptive, quality control) | Program Evaluation (Adapted from previous studies | Caregiver satisfaction with and utility of intervention; quality assurance | Caregiver | Telephone survey following T3 |
Note: CG=caregivers; PwD= person with dementia; T1 = baseline, T2 = 3-month follow-up; T3 = 6-month follow-up. We estimate interviews with CGs to average 1½ hours.