Effect of a telemedicine intervention for diabetes-related foot ulcers on health, well-being and quality of life: secondary outcomes from a cluster randomized controlled trial (DiaFOTo)

Table 1 Characteristics of the participants: the DiaFOTo study, Western Norway^a

Characteristics	Total	Telemedicine	Standard outpatient care
Characteristics	(n = 156)	(n = 78)	(n = 78)
Demographic variables
Male sex	115 (73.7)	57 (73.1)	58 (74.4)
Age (years)	65.5 ± 16.3	66.3 ± 16.3	64.7 ± 16.4
Married or Cohabitant	91 (60.7)	42 (56.8)	49 (64.5)
Education level^b
Primary	36 (25.5)	22 (32.4)	14 (19.2)
Secondary	73 (51.8)	34 (50.0)	39 (53.4)
Tertiary	32 (22.7)	12 (17.7)	20 (27.4)
Employed	34 (21.9)	18 (23.4)	16 (20.5)
Travel distance > 25 km to hospital	40 (27.4)	21 (28.4)	19 (26.4)
Lifestyle characteristics
Smoking (yes)	27 (18.1)	14 (18.9)	13 (17.3)
Subgroups of diabetes
Type 1 diabetes	35 (22.4)	11 (14.1)	24 (30.8)
Type 2 diabetes	121 (77.6)	67 (85.9)	54 (69.2)
Diabetes-related variables
Diabetes duration, years	20.8 ± 15.0	19.8 ± 14.1	21.8 ± 15.8
Insulin treatment	101 (65.2)	47 (61.0)	54 (69.2)
HbA_1c, (mmol/mol)^c	63 ± 18.6	63 ± 17.5	64 ± 18.6
HbA_1c, (%)^b	7.9 ± 1.7	7.9 ± 1.6	8.0 ± 1.7
Ulcer characteristics
Localization of ulcer
Toe	80 (51.3)	49 (62.7)	31 (39.8)
Metatarsal	23 (14.7)	8 (10.3)	15 (19.2)
Heal	12 (7.7)	7 (9.0)	5 (6.4)
Other	41 (26.3)	14 (18.0)	27 (34.6)
Comorbidities
Cardiovascular disease^d	42 (27.3)	19 (24.7)	23 (29.9)
Neuropathy^e	102 (70.0)	51 (70.0)	51 (70.0)
Renal disease, GFR < 60	58 (37.2)	31 (39.7)	27 (34.6)
Retinopathy	53 (37.1)	23 (31.9)	30 (42.3)
Ulcer endpoints
Healing	124 (79.5)	64 (82.1)	60 (76.9)
Amputation	15 (9.6)	4 (5.1)	11 (14.1)
Death	9 (5.8)	4 (5.1)	5 (6.4)
Not healed after 12 months	8 (5.1)	6 (7.8)	2 (2.6)

Data are shown as n (%) Percent of patients with valid values for categorical variables and mean ± SD for continuous variables
^aIn the current study we included all participants with at least one valid patient-reported outcome measure at baseline
^bEducation level: primary: up to 10 years of compulsory education, secondary: high school or vocational school and tertiary: college/university
^cHbA1c measurements were reported using the International Federation of Clinical Chemistry units (mmol/mol) in addition to the derived NGSP units (%) upon attendance at the outpatient clinic
^dCardiovascular disease was defined as a history of angina pectoris, myocardial infarction or stroke
^eNeuropathy: Neuropathy was defined as an abnormal pressure sensation evaluated with the 10 g monofilament and/or presence of symptoms and/or signs of peripheral nerve dysfunction

ISSN: 1472-6823