Skelly 2009.
| Methods |
Group randomised controlled clinical trial (RCT): (2/3 of participants were randomly assigned to the intervention, 1/3 to a diet and weight control intervention. Control group received an attention‐control intervention. Of the participants randomly assigned to receive the intervention, half were randomly assigned to receive a telephone booster after 6 months, and half were randomly assigned to not receive this booster. Will not include booster analysis in this review) Randomisation ratio: 2:1 intervention:control Superiority design |
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| Participants |
Inclusion criteria:
Exclusion criteria:
Others not specified Participating population: African American women over 50 years of age who had type 2 diabetes and lived in a rural area |
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| Interventions |
Number of study centres: not stated Treatment before study: unclear Intervention: Intervention consisted of 4 60‐minute fortnightly home visits by a nurse to participant's house. Intervention was symptom‐focused and involved teaching and counselling. Each session was guided by a different module: (1) symptoms of hyperglycaemia, (2) symptoms of hypoglycaemia, (3) numbness and tingling in the feet/foot pain and (4) prevention of cardiovascular symptoms. The intervention was individualised by allowing participants to choose in what order they addressed symptoms and what management strategies they used. Intervention was made culturally appropriate by incorporating women's own coping strategies (e.g. spirituality, importance of family) and allowing time for women to tell their own stories about living with diabetes. In addition, an advisory board of 6 African American women living in similar communities as participants guided development of study materials. Booster intervention started after 6 months (about 3 months after intervention finished) and consisted of 4 telephone calls by nurse who had carried out intervention at intervals of about 2‐3 weeks Control: Control participants also received 4 60‐minute fortnightly home visits by a nurse (a different nurse from the one who carried out the symptom‐focused intervention). However, instead of a symptom‐focused intervention, the control group received a weight and diet program. The 4 modules delivered across the 4 sessions were weight maintenance (2 modules), fat modification and sodium modification. Participants were taught skills to enhance diabetes self‐care (e.g. reading labels, determining portion sizes). This intervention was also individualised and was culturally tailored. It was expected that this intervention would not be effective, but actually it was, probably because it was individualised to each participant Provider: nurse |
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| Outcomes | Assessed at 3, 6 and 9 months
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| Study details |
Run‐in period: unclear Study terminated before regular end: no |
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| Publication details |
Language of publication: English Funding: National Institute of Nursing Research grant Publication status: peer‐reviewed journal |
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| Stated aim of study | Quote from publication: "To test the effectiveness of a symptom‐focused diabetes intervention on older African American women with type 2 diabetes" | |
| Notes | ‐ | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: unclear how randomisation procedure was carried out |
| Allocation concealment (selection bias) | Low risk | Quote from publication: "Allocation concealed in sealed, opaque envelopes, that were opened in a verified system, which assured that participants received assignment in the order in which they were enrolled" |
| Blinding of participants and personnel (performance bias) Objective outcomes | Unclear risk | Comment: no data used |
| Blinding of participants and personnel (performance bias) Subjective outcomes | Unclear risk | Comment: no data used |
| Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C | Unclear risk | Comment: no data used |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Comment: no data used |
| Incomplete outcome data (attrition bias) Objective outcomes | Unclear risk | Comment: no data used |
| Incomplete outcome data (attrition bias) Subjective outcomes | Unclear risk | Comment: no data used |
| Selective reporting (reporting bias) | Unclear risk | Comment: no data used |
| Other bias | Unclear risk | Comment: no data used |