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)

Iversen, Marjolein M.; Igland, Jannicke; Smith-Strøm, Hilde; Østbye, Truls; Tell, Grethe S.; Skeie, Svein; Cooper, John G.; Peyrot, Mark; Graue, Marit

doi:10.1186/s12902-020-00637-x

Table 2 Patient-reported outcomes comparing telemedicine versus standard outpatient care: the DiaFOTo study, Western Norway^a

From: 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)

		Telemedicine (n = 78)					Standard Outpatient Care (SOC) (n = 78)				Intervention effect
		Baseline		Follow-up	p-value		Baseline		Follow-up	p-value	Effect^b	p-value
Generic Quality of Life measures^c	n		n			n		n
EQ-5D-5L, (0–1)	75	0.72 (0.3)	67	0.76 (0.2)	0.06	72	0.70 (0.3)	56	0.75 (0.2)	0.02	−0.01 (−0.08, 0.05)	0.66
EQ-VAS, (0–100)	74	59.0 (21.8)	68	60.4 (21.7)	0.53	73	57.7 (20.8)	57	63.5 (21.4)	0.02	−3.99 (−10.17, 2.19)	0.21
WHO-5, (0–100)	73	63.2 (21.0)	64	65.4 (19.8)	0.44	67	59.4 (21.5)	54	62.4 (20.6)	0.48	−0.67 (−6.74, 5.39)	0.83
HADS-A, (0–21)	77	4.3 (3.3)	66	4.5 (3.9)	0.89	78	4.6 (4.0)	58	4.7 (3.9)	0.43	−0.25 (−1.28, 0.78)	0.63
HADS-D, (0–21)	77	4.7 (3.3)	66	4.7 (3.9)	0.88	78	5.4 (4.1)	58	5.1 (3.5)	0.57	0.15 (−0.83, 1.1)	0.76
Disease-specific Quality of Life measures^c
PAID-20, mean (SD)	68	21.6 (18.6)	64	25.4 (20.0)	0.04	62	21.4 (18.3)	48	22.3 (18.0)	0.76	2.56 (−1.95, 7.06)	0.27
PAID-20 ≥ 40 (%)	68	14 (20.6)	64	11 (17.2)	0.31	62	8 (12.9)	48	7 (14.6)	0.85	−0.34 (−1.22, 0.54)	0.45
NeuroQOL weighted (1–15)
Painful symptoms	75	4.0 (2.2)	65	4.1 (2.6)	0.97	73	4.2 (2.7)	58	4.2 (2.7)	0.89	0.06 (−0.77–0.88)	0.90
Reduced feeling	71	4.8 (3.7)	63	4.4 (3.3)	0.19	70	5.2 (3.3)	55	4.7 (3.3)	0.26	−0.03 (−1.06–0.99)	0.95
Diffuse sensorimotor symptoms	70	5.8 (4.2)	64	5.5 (4.3)	0.29	71	5.7 (4.0)	54	5.4 (3.7)	0.12	0.23 (−0.78–1.24)	0.66
ADL restrictions	69	7.2 (4.2)	58	6.5 (3.7)	0.19	70	8.2 (4.4)	52	6.3 (4.0)	0.003	1.05 (−0.65–2.75)	0.23
Interpersonal burden	70	5.5 (3.9)	59	5.1 (4.0)	0.18	71	5.3 (3.5)	50	4.7 (3.6)	0.20	0.02 (−1.18–1.22)	0.97
Emotional distress	75	4.0 (2.2)	63	4.1 (2.6)	0.97	73	4.2 (2.7)	53	4.2 (2.7)	0.89	0.06 (−0.77–0.88)	0.90

Data are shown as mean ± SD for continuous variables and n (%) percent for categorical variables
^aIn the current study we included all participants with at least one valid patient-reported outcome measure at baseline
^bRegression coefficient for interaction between time and treatment group in linear mixed effects model for continuous outcome and generalized estimation equations (GEE) for binary outcomes
^cHigher scores on EQ-VAS, or WHO-5 reflect better perceived health, health state or psychological well-being. Higher scores on EQ-5D, HADS-anxiety or –depression or PAID-20 reflect lower health-related quality of Life, more anxiety or depressive symptoms or more diabetes distress; Higher scores on the NeuroQOL reflect greater impact of foot ulcers on quality of life

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ISSN: 1472-6823

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