Skelly 2005.

Methods	Parallel randomised controlled clinical trial (RCT) Randomisation ratio: 23 intervention:18 control Superiority design
Participants	Inclusion criteria: Age 50‐85 years Women with type 2 DM No cognitive, affective or functional dysfunction preventing them from participating in the intervention Exclusion criteria: BDI‐II score 29 SPMSQ error 8‐10 (depression or intellectual impairment) Diagnostic criteria: not stated Participating population: older African American women in rural area in North Carolina
Interventions	Number of study centres: One health department; two community‐based practices; one community health centre providing primary care in 3 rural counties of a southeastern state Treatment before study: not stated Intervention: individual biweekly visits to individuals' homes lasting < 1 hour, with 4 achievable modules on teaching and counselling intervention based on patient‐nurse collaboration. Total time spent with participants was 6 hours. Provider was a nurse‐investigator not blinded to participants' group assignment Control: Control group received also 2 pre‐intervention visits, during which demographic data were collected and study instruments administered. Controls also received a telephone call at a midpoint between baseline and final evaluation details. Total time spent was 3 hours and time spent on a telephone call Provider: nurse
Outcomes	Outcomes reported in abstract of publication: Primary outcome(s): Symptoms distress and its effects on QoL diabetes management, etc, measured by DSDS (Diabetes Symptoms Distress Scale) Diabetes knowledge (Diabetes Knowledge Test, and New Leaf Diabetes Knowledge Instrument) HbA1c QoL (with Quality of LIfe in Diabetes Instrument) Diabetes self‐care practices (instrument developed by Skelly et al 1995) Participant satisfaction with intervention assessed using structured in‐depth interviews Secondary outcome(s): Not stated primary or secondary outcomes
Study details	Run‐in period: not stated Study terminated before regular end: no
Publication details	Language of publication: English Funding: National Institute of Nursing Research Grant Publication status: peer‐reviewed journal
Stated aim of study	Quote from publication: "To assess the effect of culturally sensitive symptoms‐focused intervention in older African‐American women with type 2 DM in a rural area"
Notes	‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: used random tables
Allocation concealment (selection bias)	Unclear risk	Comment: no mention
Blinding of participants and personnel (performance bias) Objective outcomes	High risk	Comment: participants and providers not blinded
Blinding of participants and personnel (performance bias) Subjective outcomes	Unclear risk	Comment: no subjective outcomes used in data analysis
Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C	Low risk	Comment: outcome assessors not blinded but unlikely to have affected HbA1c
Blinding of outcome assessment (detection bias) Subjective outcomes	Unclear risk	Comment: no subjective outcomes used in data analysis
Incomplete outcome data (attrition bias) Objective outcomes	Unclear risk	Comment: not stated whether ITT used. 4 of 47 lost to follow‐up. Few reasons given
Incomplete outcome data (attrition bias) Subjective outcomes	Unclear risk	Comment: no subjective outcomes used in data analysis
Selective reporting (reporting bias)	Unclear risk	Comment: protocol not seen
Other bias	Unclear risk	Comment: none