Table 1 Summary of outcomes, measures/approaches, and methods of analysis
Objective | Outcomes | Measures/approaches | Methods of analysis |
|---|---|---|---|
1. Feasibility of program implementation | Client acceptability | -Semi-structured interview (at 6 months) | -Content analysis |
-% of participants that did not die or transfer to long-term care and completed the 6-month program | -Descriptive statistics | ||
-% of completers that had at least 1 home visit | -Descriptive statistics | ||
-% of completers that had at least 1 group session | |||
Provider acceptability | -Focus group interview (at 6 months) | -Content analysis | |
Peer support volunteer acceptability | -Focus group interview (at 6 months) | -Content analysis | |
Implementation barriers and facilitators | -Focus groups (providers) | -Content analysis | |
-Semi-structured interviews (clients) | |||
Fidelity | -Compare log (visits, case conferences, group attendance) to fidelity checklist | -Rating of compliance | |
-Descriptive feedback | |||
2. Feasibility of study methods | Eligibility | -No. of individuals screened and found eligible to participate in study | -Descriptive statistics |
Recruitment | -No. of eligible participants enrolled in study | -Descriptive statistics | |
Retention | -% of enrolled participants that completed 6-month program | -Descriptive statistics | |
Representative | -Comparison of completers and non-completers (characteristics: sociodemographic, self-management, health status, cost characteristics) | -Descriptive statistics | |
Data collection and analysis | -Length of interview | -Content analysis | |
-Clarity and acceptability of questions | |||
-Applicability of questions to clients | |||
-Ease of data collection | |||
-Follow-up on missing or inconsistent response data | |||
-Focus groups and semi-structured interviews for problems relating to data requested or issues affecting data analysis | |||
3. Change in client outcomes | Self-management behavior | -SDSCAa total scale, sub-scale items | -Mean (SD), 95 % CI for mean score difference |
Health-related quality of life | -PCSc score from SF-12b (physical) | -Mean (SD), 95 % CI for mean score difference | |
-MCSd score from SF-12b (mental) | |||
Depression | -CES-De score | -Mean (SD), 95 % CI for mean score difference | |
-Descriptive statistics (cut-off analysis) | |||
Anxiety | -GAD-7f score | -Mean (SD), 95 % CI for mean score difference | |
-Descriptive statistics (cut-off analysis) | |||
Glycated hemoglobin | -HbA1C measure (% sugar in blood) | -Mean (SD), 95 % CI for mean difference | |
Hypoglycemic episodes (blood glucose <4 mmol/L) | -Number (proportion) of clients in each category: not sure, never or hardly ever, more than once a month, more than once a week, daily or almost daily | -Descriptive statistics | |
Diabetes medication use | -Number (proportion) of clients in each category: increased medications, decreased medications, no change in medications | -Descriptive statistics | |
Costs | -6-month costs by service type | -Median costs | |
4. Primary outcome for full RCT | SDSCA, PCS, HbA1C | -Applicability to clients | -Comprehensive performance evaluation of candidate outcome measures |
-Face validity | |||
-Ease of collection/completion |