Evaluation of the effects of a diabetes educational program: a randomized clinical trial

Torres, Heloísa de Carvalho; Pace, Ana Emília; Chaves, Fernanda Figueredo; Velasquez-Melendez, Gustavo; Reis, Ilka Afonso

doi:10.11606/S1518-8787.2018052007132

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Original Articles • Rev. Saúde Pública 52 • 2018 • https://doi.org/10.11606/S1518-8787.2018052007132 copy

Evaluation of the effects of a diabetes educational program: a randomized clinical trial

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

OBJECTIVE

Evaluate the effectiveness of a diabetes mellitus educational program in primary health care.

METHODS

This cluster randomized trial was conducted in a sample of 470 people with type 2 diabetes mellitus from eight health units, randomly assigned to two groups: intervention (n = 231) and control (n = 239). The intervention group participated in the educational program composed of three strategies: group education, home visit, and telephone intervention. Simultaneously, the control group was monitored individually. Group monitoring took place over nine months in the year 2012. Clinical evaluations were performed at the initial time (T₀), three (T₃), six (T₆) and nine (T₉) months after the beginning of the intervention.

RESULTS

After nine months of follow-up, 341 users remained in the study, 171 in the control group and 170 in the intervention group. The average age of users was 60.6 years. In both groups, statistically significant differences were observed in mean HbA1c levels over the follow-up time (p < 0.05). However, the mean HbA1c level at T₃, T₆ and T₉ times were significantly lower among the people in the intervention group (p < 0.05).

CONCLUSIONS

The educational program model developed was effective to improve the glycemic control of the intervention group participants.

DESCRIPTORS
Diabetes Mellitus, Type 2, prevention & control; Self Care; Health Education; Health Programs and Plans; Evaluation of the Efficacy-Effectiveness of Interventions; Outcome and Process Assessment (Health Care)

Variable		Initial (T₀)			Final (T₉)
Variable		Control	Intervention	p^a a T-Student-Welch for independent samples or chi-square test.	Control	Intervention	p^a a T-Student-Welch for independent samples or chi-square test.
Gender		(n = 239)	(n = 231)		(n = 171)	(n = 170)
	Female	161 (67.4%)	164 (71.0%)	0.452	118 (69.0%)	127 (74.7%)	0.294
	Male	78 (32.6%)	67 (29.0%)	0.452	53 (31.0%)	43 (25.3%)	0.294
Occupation		(n = 230)	(n = 227)		(n = 167)	(n = 168)
	Active	65 (28.3%)	55 (24.2%)	0.383	42 (25.1%)	39 (23.2%)	0.775
	Inactive	165 (71.7%)	172 (75.8%)	0.383	125 (74.9%)	129 (76.8%)	0.775
Marital status		(n = 230)	(n = 226)		(n = 167)	(n = 167)
	Had partner	127 (55.2%)	119 (52.7%)	0.649	93 (55.7%)	88 (52.7%)	0.660
	Without partner	103 (44.8%)	107 (47.3%)	0.649	74 (44.3%)	79 (47.3%)	0.660
Education^b b The groups are statistically different in the percentage of illiterate people.		(n = 230)	(n = 225)		(n = 167)	(n = 167)
	Illiterate	13 (5.7%)	38 (16.9%)	0.0003	13 (7.8%)	28 (16.8%)	0.020
	Literate	217 (94.3%)	187 (83.1%)	0.0003	154 (92.2%)	139 (83.3%)	0.020
Age (years)		(n = 230) 62.5 (10.5)	(n = 223) 62.1 (10.9)	0.682	(n = 167) 62.8 (10.5)	(n = 165) 63.4 (10.6)	0.475
Income (minimum wage)		(n = 230) 1.8 (1.9)	(n = 214) 1.9 (1.8)	0.846	(n = 167) 1.7 (1.9)	(n = 157) 1.7 (1.4)	0.827
Disease duration (years)		(n = 229) 9.8 (8.1)	(n = 221) 9.2 (8.1)	0.463	(n = 166) 9.9 (8.5)	(n = 163) 9.4 (8.3)	0.614
Body mass index (kg/m²)		(n = 230) 28.6 (5.1)	(n = 224) 29.2 (5.6)	0.272	(n = 167) 29.2 (5.3)	(n = 165) 28.6 (5.3)	0.389
Abdominal circumference (cm)		(n = 230) 101.5 (12.5)	(n = 222) 100.0 (13.7)	0.243	(n = 131) 101.5 (13.4)	(n = 143) 100.6 (12.9)	0.602

Variable	Group	Time
Variable	Group	T₀	T₃	T₆	T₉
	Intervention	7.88^a a.b.c Equal letters on the same line indicate that the mean difference between two time periods is statistically zero (Student t-test paired with Bonferroni correction). (2.19) (n = 155)	8.31 (2.01) (n = 155)	7.95^a a.b.c Equal letters on the same line indicate that the mean difference between two time periods is statistically zero (Student t-test paired with Bonferroni correction). (1.86) (n = 155)	7.93^a a.b.c Equal letters on the same line indicate that the mean difference between two time periods is statistically zero (Student t-test paired with Bonferroni correction). (2.06) (n = 155)
HbA1c (%)		p < 0.05
	Control	7.83^a a.b.c Equal letters on the same line indicate that the mean difference between two time periods is statistically zero (Student t-test paired with Bonferroni correction). (2.08) (n = 155)	8.59^b a.b.c Equal letters on the same line indicate that the mean difference between two time periods is statistically zero (Student t-test paired with Bonferroni correction). (2.06) (n = 155)	8.53^b a.b.c Equal letters on the same line indicate that the mean difference between two time periods is statistically zero (Student t-test paired with Bonferroni correction). (2.11) (n = 155)	8.29^b a.b.c Equal letters on the same line indicate that the mean difference between two time periods is statistically zero (Student t-test paired with Bonferroni correction). (2.22) (n = 155)
		p < 0.05
	Intervention	188.48^a a.b.c Equal letters on the same line indicate that the mean difference between two time periods is statistically zero (Student t-test paired with Bonferroni correction). (55.41) (n = 155)	181.50^a a.b.c Equal letters on the same line indicate that the mean difference between two time periods is statistically zero (Student t-test paired with Bonferroni correction). .^b a.b.c Equal letters on the same line indicate that the mean difference between two time periods is statistically zero (Student t-test paired with Bonferroni correction). (42.21) (n = 155	178.89^b a.b.c Equal letters on the same line indicate that the mean difference between two time periods is statistically zero (Student t-test paired with Bonferroni correction). (38.95) (n = 155)	180.07^a a.b.c Equal letters on the same line indicate that the mean difference between two time periods is statistically zero (Student t-test paired with Bonferroni correction). .^b a.b.c Equal letters on the same line indicate that the mean difference between two time periods is statistically zero (Student t-test paired with Bonferroni correction). (41.39) (n = 155)
Total cholesterol (mg/dL)		p < 0.05
	Control	188.13^a a.b.c Equal letters on the same line indicate that the mean difference between two time periods is statistically zero (Student t-test paired with Bonferroni correction). (45.11) (n = 155)	188.28^a a.b.c Equal letters on the same line indicate that the mean difference between two time periods is statistically zero (Student t-test paired with Bonferroni correction). (46.13) (n = 155	184.77^a a.b.c Equal letters on the same line indicate that the mean difference between two time periods is statistically zero (Student t-test paired with Bonferroni correction). (43.87) (n = 155)	183.38^a a.b.c Equal letters on the same line indicate that the mean difference between two time periods is statistically zero (Student t-test paired with Bonferroni correction). (39.84) (n = 155)
		p>0.05
	Intervention	40.54 (31.87) (n = 155)	41.87^b a.b.c Equal letters on the same line indicate that the mean difference between two time periods is statistically zero (Student t-test paired with Bonferroni correction). (12.51) (n = 155)	41.69^b a.b.c Equal letters on the same line indicate that the mean difference between two time periods is statistically zero (Student t-test paired with Bonferroni correction). (10.48) (n = 155)	43.16^b a.b.c Equal letters on the same line indicate that the mean difference between two time periods is statistically zero (Student t-test paired with Bonferroni correction). (10.52) (n = 155)
HDL-C^d d Analysis was done using the logarithmic scale (Box-Cox transformation). (mg/dL)		p < 0.05
	Control	43.11^a a.b.c Equal letters on the same line indicate that the mean difference between two time periods is statistically zero (Student t-test paired with Bonferroni correction). (36.59) (n = 155)	59.95^b a.b.c Equal letters on the same line indicate that the mean difference between two time periods is statistically zero (Student t-test paired with Bonferroni correction). (35.50) (n = 155)	42.36^c a.b.c Equal letters on the same line indicate that the mean difference between two time periods is statistically zero (Student t-test paired with Bonferroni correction). (12.09) (n = 155)	42.97^c a.b.c Equal letters on the same line indicate that the mean difference between two time periods is statistically zero (Student t-test paired with Bonferroni correction). (10.86) (n = 155)
		p < 0.05

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[1] Correspondence: Heloísa de Carvalho Torres Escola de Enfermagem – UFMG Av. Alfredo Balena, 190 Santa Efigênia 30130-100 Belo Horizonte, MG, Brasil E-mail: heloisa@enf.ufmg.br