Multicomponent Program to Reduce Functional Decline in Frail Elderly People: A Cluster Controlled Trial

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Figure 1.
Flow diagram of practices and participants. GP, general practitioner.

Table 1. Baseline Characteristics of Participants in the Intervention Group and Control Group

Characteristics	CareWell Primary Care (n = 287)	Usual Care (n = 249)	P Value for Difference
Age (years), mean (SD)	83.1 (5.6)	80.5 (6.0)	.42
Female sex	192 (66.9)	160 (64.3)	.52
Living alone	182 (63.4)	136 (54.6)	.039
Socioeconomic status score,^* mean (SD)	0.5 (1.1)	0.2 (0.5)	<.001
Low level of education	69 (24.1)	100 (41.0)	<.001
Cognition score,^{^†} mean (SD)	7.5 (7.0)	5.3 (4.8)	<.001
Katz-15 index,^{^‡} mean (SD)	5.4 (2.9)	4.6 (2.7)	.33
EQ-5D+C,^{^§} mean (SD)	0.6 (0.3)	0.6 (0.3)	.08
RAND-36 mental health^{^¶}	61.1 (13.1)	62.4 (13.7)	.38
Presence of health-related limitations in social functioning^{^‖}	178 (64.3)	88 (37.1)	<.001
Frailty index,^** mean (SD)	0.4 (0.2)	0.4 (0.2)	.90
Presence of care complexity	60 (21.1)	75 (30.1)	.017

Data are expressed as numbers (percentage) unless otherwise indicated.
↵* Socioeconomic status score was based on postal code areas (income, employment, and education); a higher score indicates more social disadvantage.
↵† Based on a modified Mini-Mental State Examination (range, 0–28); a higher score indicates more cognitive problems.
↵‡ Katz-15 scores range from 0 to 15; a higher score indicates more dependence in (instrumental) activities of daily living.
↵§ EQ-5D+C scores range from −0.33 to 1.00; a higher score indicates a higher health-related quality of life.
↵¶ The 36-item RAND Mental Health questionnaire (RAND-36) scores range from 0 to 100; a higher score indicates better mental health.
↵‖ Based on the social functioning subscale of the RAND-36. Answers were dichotomized as the “absence of limitations” vs. the other categories indicating the “presence of limitations.”
↵** The frailty index measures accumulated deficits (scale 0 to 1); a higher index suggests a more frail status.
EQ-5+C, EuroQuol instrument; SD, standard deviation.

Table 2. Effects of the CareWell Primary Care Program on Primary and Secondary Outcomes

Outcome	CareWell Primary Care^* (n = 204)		Usual Care^* (n = 165)		Estimated Intervention Effect^* (95% CI)	P Value
Outcome	Baseline	Change at Follow-up	Baseline	Change at Follow-up	Estimated Intervention Effect^* (95% CI)	P Value
Katz-15 index^{^†}	5.4 (2.9)	0.8 (1.9)	4.6 (2.7)	0.5 (2.1)	0.37 (−0.1 to 0.8)	.10
EQ-5D+C^{^‡}	0.6 (0.3)	0.0 (0.3)	0.6 (0.3)	0.0 (0.3)	−0.031 (−0.1 to 0.0)	.37
RAND-36 mental health^{^§}	61.1 (13.1)	−0.28 (13.6)	62.4 (13.7)	−0.8 (13.7)	0.86 (−2.3 to 4.0)	.56
Health-related limitations in social functioning^{^¶}	1.5 (1.4)	−0.1 (1.6)	0.9 (1.3)	0.3 (1.7)	0.037 (0.2–0.2)	.76

Data are mean (standard deviation) unless otherwise indicated.
↵* Adjusted for clustering; baseline values of relevant covariates (living situation, health-related limitations in social functioning, cognition score, socioeconomic status score, and care complexity); baseline value of the Katz-15 index; and, in the case of secondary outcomes, baseline value of the outcome parameter.
↵† Katz-15 scores range from 0 to 15; a higher score indicates more dependence in (instrumental) activities of daily living.
↵‡ EQ-5D+C scores range from −0.33 to 1.00; a higher score indicates a higher health-related quality of life.
↵§ The 36-item RAND Mental Health questionnaire (RAND-36) mental health scores range from 0 to 100; a higher score indicates better mental health.
↵¶ Based on the social functioning subscale of the RAND-36. Answers are dichotomized as the “absence of limitations” vs. the other categories indicating the “presence of limitations.”
CI, confidence interval; EQ-5D+C, EuroQol instrument.

Table 3. Admissions and Mortality During Follow-up

Outcome	CareWell Primary Care (n = 204)	Usual Care (n = 165)	Odds Ratio (95% CI)	P Value
Residential and nursing home admissions	24 (8.3)	13 (5.2)	1.32 (0.64–2.71)	.46
Hospital admissions	52 (18.1)	57 (22.9)	0.74 (0.48–1.14)	.17
Mortality	31 (10.8)	21 (8.4)	1.13 (0.61–2.08)	.70