No identifiable Hb1Ac or lifestyle change after a comprehensive diabetes programme including motivational interviewing: A cluster randomised trial

Figures & data

Figure 1. The interventions in the comprehensive programme.

Figure 2. Flow diagram of general practices and patients at different stages (enrolment, allocation, baseline measurement, follow-up, and analysis) of the trial.

Table I. Baseline characteristics of general practices, primary care nurses, patients, and baseline values of measures.

	Intervention		Usual care
		SD		SD
General practices (n = 53):^a	25		28
Mean number of patients in general practice^b	4566	2703.8	5657	4153.3
Mean number of patients with type 2 diabetes in general practice	195	109.6	202	119.4
Mean FTE^c primary care nurses in general practice	0.6	0.3	0.8	0.6
Primary care nurses (n = 53):^d	25		28
Mean age in years	40.7	7.8	44.4	6.6
Number of men/number of woman	2/23		1/27
Mean years of experience with diabetes consultations	3.6	2.1	3.6	2.1
Nurses who were formerly practice assistants	48.0		53.6
Mean years of experience as practice assistant	4.3	5.3	8.4	8.8
Patients (n = 521):	229		292
% men	55.9		54.0
Mean age in years	64.1	8.9	63.9	9.8
Mean duration of diabetes in years	7.5	6.0	7.8	5.8
Baseline (n = 336):	134		202
Outcome measures:
HbA1c, %	7.8	0.9	7.7	0.7
Systolic blood pressure, mm Hg	144.4	20.3	140.7	18.0
Diastolic blood pressure, mm Hg	81.9	10.6	79.9	9.9
LDL, mmol/l	2.8	1.0	2.5	0.8
Total cholesterol, mmol/l	4.7	1.0	4.5	1.0
BMI, kg/m^2	30.7	4.2	30.7	4.2
Lifestyle:
Alcohol, units/day^e	2.3	1.0	2.2	1.1
Fat score, g/day	14.1	4.5	14.5	4.9
Vegetables, tablespoons/day	2.9	1.6	3.0	1.5
Fruit, pieces/day	1.9	1.1	1.8	1.1
Physical activity, minutes/day	64.8	66.1	58.6	45.1
Pam score^f	19.2	8.5	21.2	8.0
Low activity, minutes/day	73.2	40.3	77.0	37.0
Medium activity, minutes/day	21.1	23.4	23.4	23.8
High activity, minutes/day	0.3	0.8	0.7	3.3
Diary activity, minutes/day	129.9	77.4	153.9	103.4
Quality of life:
VAS score	74.1	16.2	73.1	13.5

Notes: ^aFour general practices withdrew from the study before the nurse had completed the questionnaire about the baseline characteristics. ^bSD = standard deviation. ^cFTE = full time equivalent; ^dIn six practices two nurses were employed. In such cases we calculated the mean of the nurse characteristics, because the mean values were used in follow-up analyses. ^eOnly people who reported alcohol consumption. ^fPam score = Personal activity meter score.

Table II. Effect of comprehensive diabetes programme on diabetes outcome measures, lifestyle, and quality of life after 14 months’ follow-up.^a

	Intervention			Usual care			Difference between groups^b	95% CI	p-value
	M	SD	n	M	SD	n
Outcome measures:
HbA1c, %	7.3	0.7	129	7.4	1.0	197	0.13	−0.08 – 0.35	0.221
Systolic blood pressure, mm Hg	141.5	17.0	120	137.8	15.8	185	−1.98	−5.63 – 1.67	0.279
Diastolic blood pressure, mm Hg	79.5	8.4	120	77.6	9.2	120	−1.17	−3.41 – 1.07	0.294
LDL, mmol/l	2.6	0.8	106	2.4	0.6	178	−0.15	−0,32 – −0.02	0.081
Total cholesterol, mmol/l	4.5	1.0	122	4.2	0.8	186	−0.21	−0.41 – 0.00	0.051
BMI, kg/m^2	30.2	4.0	106	30.5	4.6	179	0.36	−0.19 – 0.90	0.198
Lifestyle:
Alcohol, units/day^c	2.2	1.0	58	2.2	1.1	95	0.04	−0.14 – 0.23	0.647
Fat score, g/day	13.9	5.4	105	14.2	6.1	163	0.19	−0.82 – 1.21	0.708
Vegetables, tablespoons/day	3.1	1.6	102	3.1	1.5	165	0.10	−0.21 – 0.41	0.518
Fruit, pieces/day	1.8	1.1	119	1.7	1.2	173	−0.02	−0.26 – 0.22	0.884
Physical activity, minutes/day	62.8	69.6	124	59.1	51.3	171	−1.15	−12.26 – 9.97	0.839
Pam score^d
Low activity, minutes/day	78.3	40.3	78	78.8	39.8	120	−2.70	−10.52 – 5.14	0.498
Medium activity, minutes/day	22.5	27.0	78	22.6	20.2	120	−1.46	−6.80 – 3.89	0.592
High activity, minutes/day	0.4	0.9	78	1.0	6.5	120	0.18	−0.65 – 1.01	0.669
Diary activity, minutes/day	152.9	97.6	84	157.4	89.0	128	−19.36	−39.97 – 1.26	0.066
Quality of life:
VAS score	75.3	16.2	111	73.5	13.6	171	−1.27	−4.50 1.97	0.441

Notes: ^aAdjusted for baseline measures, nurses’ years of experience, and cluster effects. ^bDifference between intervention and usual care group (reference group). ^cOnly people who reported alcohol consumption. ^dPam score = Personal activity meter score.

Table III. Effect of comprehensive diabetes programme on patient's readiness to change lifestyle^a after 14 months’ follow-up.^b

	Intervention			Usual care
	M	SD	n	M	SD	n	B	95% CI	p-value
Alcohol, units/week^c	12.8	4.1	11	10.5	3.6	18	−1.03	−3.93 – 1.86	0.471
Fat, g/day	14.8	6.0	30	13.0	3.9	43	0.21	−3.19 – 3.60	0.901
Vegetables, g/day	12.5	5.1	89	13.7	4.5	150	0.74	−0.47 – 1.96	0.228
Fruit, pieces/day	12.5	4.4	71	11.9	4.1	116	−0.38	−1.82 – 1.05	0.597
Physical activity, minutes/day	11.7	5.4	63	11.1	4.1	126	−0.48	−2.13 – 1.17	0.563

Notes: ^aOnly for patients who did not reach the norm for lifestyle; range 1–25. ^bAdjusted for baseline measures and nurses’ years of experience. ^cOnly people who reported alcohol consumption.

Table IV. Effect of comprehensive diabetes programme on diabetes process indicators after 14 months’ follow-up.^a

	Number of patients (%)
	Interventionn = 186	Usual caren = 263	Odds ratio	95% CI	p-value
Dietary advice	104 (56)	119 (45)	0.96	0.86 – 1.06	0.838
Physical activity advice	106 (57)	116 (44)	0.96	0.87 – 1.06	0.984
HbA1c checked	182 (99)	251 (95)	2.13	0.60 – 7.53	0.239
Blood pressure checked	185 (100)	245 (93)	13.59	1.79 – 103.37	0.01
Total cholesterol checked	174 (94)	242 (92)	0.99	0.94 – 1.04	0.554
LDL cholesterol checked	169 (91)	239 (91)	2.25	1.01 – 5.00	0.838
Creatinine (serum) checked	174 (94)	242 (92)	1.02	0.96 – 1.07	0.322
Microalbuminuria checked	163 (88)	223 (85)	0.98	0.93 – 1.04	0.931
Eye examination^b	61 (33)	106 (40)	1.01	0.96 – 1.06	0.717
Foot examination	131 (70)	205 (78)	0.98	0.94 – 1.02	0.101
BMI determined	166 (89)	230 (87)	0.97	0.91 – 1.04	0.832
Cholesterol-lowering medication	80 (43)	93 (36)	0.97	0.88 – 1.07	0.955

Notes: ^aAdjusted for baseline measures and nurses’ years of experience. ^bIn general once in 24 months, but eye examinations were recorded in the last 12 months.