Individualized Hospital to Home, Exercise-Nutrition Self-Managed Intervention for Pre-Frail and Frail Hospitalized Older Adults: The INDEPENDENCE Randomized Controlled Pilot Trial

Figures & data

Table 1 Outline of Default Participant Activities (for the Intervention Group)

Activities	Hospital Stay	After Discharge (Week)
		1	2	3	4	5	6	7	8	9	10	11	12
Nutrition therapy	x	x	x	x	x	x	x	x	x	x	x	x	x
Exercise therapy	x	x	x	x	x	x	x	x	x	x	x	x	x
Home visits			x	x		x			x
Telephone calls					x		x				x		x

Table 2 Outcome Variables Measured for All Study Participants

Outcome	Scale	Description
Pre-frailty and frailty	Edmonton Frail Scale^Citation17	Assesses nine domains – cognition, general health status, functional independence, social support, medication use, nutrition, mood, continence, and functional performance, score ranges from 0 to 17 points with higher scores indicative of a greater severity of frailty.
Lower extremity physical function	Short Physical Performance Battery^Citation45	Consist of three components: ability to stand with feet together side by side, semi-tandem, and tandem, timed trials of 4-meter walk, and sit-to-stand test. Score range from 0 to 12 points with higher scores indicating better function and 10 or more indicates robustness.
Grip strength	Hand-held dynamometer^Citation46	Average of three attempts with dominant hand using the TTM Advanced Hand Dynamometer, measured in kilograms.
Nutritional status	Scored Patient-Generated Subjective Global Asssessment^Citation47	Consist of a grade and score component. The grade component consists of five categories – weight, nutritional intake, nutrition impact symptoms (NIS), functioning, physical examination. An overall grade of A, B or C indicates well-nourished, moderate/suspected malnutrition or severely malnourished, respectively. The score components consist of seven categories – weight, food intake, NIS, activities and function, disease and relation to nutrition requirements, metabolic demand, physical examination, with a global assessment of nutritional status. A higher score would suggest a greater degree of malnutrition.
Cognition	Mini-mental state examination^Citation48	Consist of tests of orientation, attention, memory, language, and visual-spatial skills, ranging 0–30, with 25–30 indicating normal cognition, 24 and below suggesting mild to severe cognitive impairment as scores get lower.
Mood	Geriatric Depression Scale^Citation49	A set of 15 questions describing the respondent’s feeling over the past week. Score ranging from 0 to 15. A score of 0–5 is normal while a score greater than five suggests depression.
Health-related QoL	EuroQol-5-Dimension-5-Level^Citation50	Consists of five domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each has five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems that is combined into a 5-digit number that describes the patient’s health state. The EQ-5D Visual Analog Scale (VAS) quantifies the participant’s self-rated health on a vertical visual analogue scale from 0 to 100, with zero being the worst and 100 being the best health imagined.
Risk of functional decline	Hospital Admission Risk Profile^Citation51	Calculated with age, cognitive status, and self-reported Instrumental Activities of Daily Living (IADL) upon admission, ranging from 0 to 5, with higher scores indicative of higher risk of functional decline.
Hospital outcomes	-	The inpatient length of stay (LOS), total visits to the emergency department within 180-days post discharge, total number of reported unplanned readmissions (defined as a hospital admission resulting in an overnight stay) and total hospital LOS within 180-days post discharge, was also recorded at 3 and 6 months.

Figure 1 Overview of the Independence study with CONSORT Flow Diagram.

Notes: Adapted from Eldridge SM, Chan CL, Campbell MJ, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016;355. Copyright: © 2016 Eldridge et al. Creative Commons Attribution License.¹⁵.

Table 3 Baseline Characteristics of Study Participants (n=32)

Characteristic	Intervention (n=16)	Control (n=16)
Age, years, mean ± SD	80.0 ± 7.6	78.3 ± 5.8
Female, n (%)	11 (69)	9 (56)
Weight, kg, mean ± SD	72.5 ± 18.5	86.8 ± 29.2
Height, cm, mean ± SD	166.6 ± 8.6	168.0 ± 10.8
BMI, kg/m^2, mean ± SD	26.1 ± 6.2	30.5 ± 8.1
Charlson index, mean ± SD	4.4 ±1.6	4.4 ± 1.4
Comorbidities of significance, n (%)
Type 2 diabetes	6 (38)	2 (13)
Chronic kidney disease	2 (13)	4 (25)
Heart diseases^a	9 (56)	10 (63)
Pulmonary diseases^b	2 (13)	5 (31)
Cancer survivor^c	6 (38)	5 (31)
Medications, mean ± SD	7.5 ± 3.7	8.9 ± 4.7
On vitamin D supplements, n (%)	8 (50)	6 (43)
Education level tertiary and above, n (%)	8 (50)	7 (44)
Very low income (<$20,000), n (%)	4 (25)	4 (25)
Living status alone, n (%)	8 (50)	6 (43)
Alcohol, n (%)	0 (0)	1 (6)
Smokers, n (%)	6 (38)	4 (25)
Admission diagnosis, n (%)
Infection or sepsis	5 (31)	7 (44)
Exacerbation of COPD	2 (13)	3 (19)
Heart failure	3 (19)	1 (6)
Functional decline or fall	1 (6)	2 (6)
Postural hypotension	1 (6)	1 (6)
Headache	1 (6)	1 (6)
Atrial fibrillation	0	1 (6)
Multiple myeloma	1 (6)	0 (6)
Anemia	1 (6)	0 (6)
Social admission	1 (6)	0
Frail^d participants, n (%)
Pre-frail	3 (19)	9 (56)
Mild frail	6 (38)	3 (19)
Moderately frail	6 (38)	3 (19)
Severely frail	1 (6)	1 (6)
PG-SGA grade, n (%)
Well-nourished	5 (31)	11 (69)
Malnourished	11 (69)	5 (31)

Notes: Data expressed as mean ± SD for continuous variables; absolute numbers (percentage) for categorical variables. ^aHeart diseases in cohort: ischemic heart disease; congestive heart failure; aortic valve stenosis; chronic cardiomyopathy; coronary heart disease; atrial fibrillation.^bPulmonary diseases in cohort: chronic obstructive pulmonary disease; pulmonary fibrosis. ^cCancer history types in cohort: lung; breast; skin; colorectal; stomach; prostate. ^dFrailty status classified by the Edmonton Frail Scale.

Abbreviations: BMI, body mass index; PG-SGA, Patient-Generated Subjective Global Assessment.

Table 4 Baseline and Effects of Intervention on Outcome Variables, Intention-to-Treat Analyses

Outcome variable	Intervention	Control	Between-Group Difference^a	P-value^b
	Mean ±SD		Mean Differences (95% CI)
Edmonton Frail scale
0-month	9.1 ±1.8	8.0 ±2.0
3-month	5.7 ±3.0	8.2 ±2.5
6-month	4.9 ±3.0	6.7 ±2.0
Change from 0- to 3-month	−2.8 ±2.4	0.2 ±2.3	−3.0 (−4.8 to −3.0)	<0.001
Change from 0- to 6-month	−3.8 ±2.5	−1.4 ±1.0	−2.5 (−3.8 to −1.0)	<0.001
Short Physical Performance Battery^c – Overall
0-month	2.1 ±1.9	3.9 ±2.5
3-month	7.1 ±3.7	3.9 ±3.1
6-month	6.9 ±3.7	3.7 ±4.0
Change from 0- to 3-month	4.4 ±4.1	−0.2 ±2.5	4.0 (1.3 to 6.6)	0.003
Change from 0- to 6-month	4.1 ±3.9	−0.4 ±3.7	3.9 (1.0 to 6.9)	0.009
Short Physical Performance Battery – Gait speed test score
0-month	1.0 ±1.0	1.6 ±1.2
3-month	2.7 ±1.5	1.3 ±1.3
6-month	2.7 ±1.3	1.4 ±1.6
Change from 0 to 3-month	1.5 ±2.0	−0.4 ±1.3	1.5 (0.3 to 2.7)	0.015
Change from 0-to 6-month	1.5 ±1.8	−0.3 ±1.6	1.4 (0.2 to 2.6)	0.022
Short Physical Performance Battery – Chair stand test score
0-month	0.1 ±0.3	0.4 ±0.7
3-month	1.6 ±1.2	0.5 ±0.7
6-month	1.9 ±1.4	0.8 ±1.3
Change from 0- to 3-month	1.5 ±1.2	0.1 ±0.5	1.4 (0.6 to 2.2)	<0.001
Change from 0- to 6-month	1.7 ±1.4	0.4 ±1.3	1.2 (0.2–2.2)	0.022
Short Physical Performance Battery – Balance test score
0-month	1.0 ±1.1	1.9 ±1.1
3-month	2.6 ±1.7	2.2 ±1.7
6-month	2.3 ±1.6	1.5 ±1.7
Change from 0- to 3-month	1.3 ±1.9	0.1 ±1.6	0.8 (−0.6 to 2.1)	0.261
Change from 0- to 6-month	1.0 ±1.5	−0.5 ±1.5	1.4 (0.2 to 2.6)	0.022
Grip Strength
0-month	16.8 ±6.8	22.6 ±10.1
3-month	19.7 ±6.8	20.9 ±12.3
6-month	19.6 ±7.5	21.1 ±11.2
Change from 0- to 3-month	1.5 ±3.7	−1.7 ±7.1	3.3 (−1.1 to 7.6)	0.140
Change from 0- to 6-month	2.4 ±4.6	−1.0 ±4.5	3.7 (0.2 to 7.1)	0.039
Scored Patient Generated-Subjective Global Assessment^d
0-month	8.8 ±5.0	6.2 ±5.4
3-month	4.1 ±2.7	6.3 ±3.8
6-month	3.8 ±3.3	4.7 ±4.1
Change from 0- to 3-month	−3.4 ±4.0	0.1 ±5.6	−1.9 (−4.7 to 0.9)	0.176
Change from 0- to 6-month	−3.7 ±4.3	−1.7 ±5.1	−0.7 (−3.6 to 2.2)	0.649
Geriatric Depression Scale^e
0-month	5.6 ±3.6	4.3 ±2.6
3-month	2.9 ±2.6	3.9 ±3.1
6-month	2.8 ±3.0	4.4 ±3.4
Change from 0- to 3-month	−2.2 ±3.1	−0.6 ±2.2	−1.2 (−3.0 to 0.7)	0.211
Change from 0- to 6-month	−2.3 ±3.2	0.2 ±2.3	−2.2 (−4.1 to −0.3)	0.026
EQ-5D-5L Utility Index^f
0-month	0.6 ±0.4	0.4 ±0.4
3-month	0.7 ±0.3	0.6 ±0.4
6-month	0.7 ±0.4	0.7 ±0.2
Change from 0- to 3-month	0.3 ±0.5	0.1 ±0.3	0.2 (−0.1 to 0.5)	0.274
Change from 0- to 6-month	0.3 ±0.5	0.1 ±0.4	0.1 (−0.2 to 0.3)	0.674
EQ-5D Visual analogue scale^g
0-month	57.7 ±23.0	54.9 ±19.9
3-month	61.8 ±26.4	58.6 ±23.5
6-month	68.3 ±21.2	65.7 ±15.1
Change from 0- to 3-month	8.8 ±30.7	8.5 ±26.5	0.9 (−16.7 to 18.4)	0.924
Change from 0- to 6-month	8.8 ±19.6	8.6 ±13.0	1.2 (−9.2 to 11.7)	0.819
Hospital Admission Risk Profile^h
0-month	2.2 ±1.3	1.8 ±1.3
3-month	1.8 ±1.2	1.9 ±1.5
6-month	1.5 ±1.1	2.0 ±1.2
Change from 0- to 3-month	−0.4 ±1.2	0.1 ±1.4	−0.4 (−1.3 to 0.5)	0.419
Change from 0- to 6-month	−0.6 ±1.0	0.1 ±1.2	−0.5 (−1.3 to 0.2)	0.180
Mini-Mental State Examination^i
0-month	28.0 ±2.0	28.0 ±2.0
3-month	28.1 ±1.6	25.7 ±3.9
6-month	28.8 ±1.0	28.4 ±1.5
Change from 0- to 3-month	0.3 ±2.1	−1.8 ±3.0	2.1 (0.2 to 3.9)	0.029
Change from 0- to 6-month	0.8 ±1.8	0.6 ±1.6	0.2 (−0.8 to 1.2)	0.702

Notes: Data presented as mean ±standard deviation. ^aCoefficient from a linear regression model with follow-up values as a dependent variable and baseline values as a covariate. ^bP-values, which were derived from linear regression models with baseline values as a covariate, are for the differences in mean between intervention and control group. ^cShort Physical Performance Battery: consist of “balancing ability”, “gait speed”, and “sit-to-stand test”. Score range from 0–12 points with higher scores indicating better function and 10 or more indicates robustness. ^dScored Patient-generated Subjective Global Assessment: has scores between 0 and 35 with higher scores indicating worse nutrition status. ^eGeriatric Depression Scale has scores has scores between 0 and 15 with a higher score indicating more depressive symptoms. ^fQuality of life measured with the EQ-5D-5L utility index: has scores between 0 and 1 with higher scores indicating better health-related quality of life. ^gEQ-5D-5L visual analogue scale: has scores between 0 and 100 with higher scores indicating better health-related quality of life. ^hHospital Admission Risk Profile: has scores between 0 and 5 with higher scores indicating higher readmission risk. ⁱMini-Mental State Examination: has scores between 0 and 30 with higher scores indicating better cognition.

Abbreviation: EQ-5D-5L, EuroQol 5 Dimensions 5 Levels.

Table 5 Effects of Intervention on Clinical Outcomes, Intention-to-Treat Analyses

	Intervention	Control	P-value^a
Inpatient length of stay	8.5 (3–18)	5.5 (3–7.8)	0.402
Total length of stay in unplanned readmission within 180 days post discharge	0 (0–5.5)	1 (1–16.8)	0.160
Number of visits to emergency department within 180 days post discharge	0 (0–1)	1 (1–1.8)	0.039
Number of unplanned readmissions within 180-days post discharge	0 (0–1)	1 (0–1.8)	0.128

Notes: Data presented in median (interquartile range). ^aP-values, derived from Mann–Whitney U-test.

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