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Table 2 Primary and secondary outcomes in the LIVE@Home.Path trial

From: LIVE@Home.Path—innovating the clinical pathway for home-dwelling people with dementia and their caregivers: study protocol for a mixed-method, stepped-wedge, randomized controlled trial

Domain: name of tool Specific measurement: what the tool measures Characteristics of tool Metric Method of aggregation Time points
Primary outcome
 Resource Utilization in Dementia (RUD) (65, 66, 68) Resource utilization in dementia care Self-reported formal and informal care time use in hours/30 days on activities of daily living (e.g. feeding, dressing, bathing) and supervision (e.g. wandering, preventing dangerous situations)
Assess number of contacts with health-care professionals for both PWD and caregivers in the last 30 days, and use of medications
High number of hours of direct care time and numerous contacts with health-care professionals indicates high overall resource use in dementia care
Change in hours/30 days Mean Mean difference in hours/30 days over the 6-month intervention period summarized for the three intervention groups compared to mean difference in hours/30 days summarized for the control groupsa
Mean difference in hours/30 days over the follow-up period in 6-month intervals stratified by time from end of interventionb
 Relative Stress Scale (RSS) (69, 70) Caregiver distress 15 items for self-report of three subgroups of distress: “emotional distress”, “social distress” and “negative feelings”
Each item ranging from 0 to 4
High score indicates high burden and psychiatric morbidity
Change in total score Mean Mean difference in score over the 6-month intervention period summarized for the three intervention groups compared to mean difference in score summarized for the control groupsa
Mean difference in score over the follow-up period in 6-month intervals stratified by time from end of interventionb
Secondary outcomes
 European Quality of Life—5 Dimensions—5 Levels (EQ-5D-5L) (72) Generic quality of life Evaluates generic self-reported health-related quality of life in relation to resource use
Five items regarding mobility, self-care, activities, pain/discomfort and anxiety/depression scored on a five-level scale
Scores are converted to a single summary index number
Change in total score Mean Mean difference in score over the 6-month intervention period summarized for the three intervention groups compared to mean difference in score summarized for the control groupsa
Mean difference in score over the follow-up period in 6-month intervals stratified by time from end of interventionb
 EQ-5D-VAS scale (73) Quality of Life-VAS scale One-point measure of generic self-reported health-related quality of life rated on a visual analog scale from 0 to 100, high score indicates good quality of life Change in score Mean Mean difference in score over the 6-month intervention period summarized for the three intervention groups compared to mean difference in score summarized for the control groupsa
Mean difference in score over the follow-up period in 6-month intervals stratified by time from end of interventionb
 Quality of Life in Alzheimer’s disease scale (QoL-AD) (71) Quality of life in Alzheimer’s dementia Disease-specific self-reported quality of life measure assessing13 items each ranging from 1 to 4
High score indicates high quality of life
Change in total score Mean Mean difference in score over the 6-month intervention period summarized for the three intervention groups compared to mean difference in score summarized for the control groupsa
Mean difference in score over the follow-up period in 6-month intervals stratified by time from end of interventionb
 Neuropsychiatric Inventory, 12-item version with caregiver distress (NPI-12) (74) Neuropsychiatric symptoms in dementia Proxy-rated presence, severity and caregiver distress of 12 items assessing depression, anxiety, psychosis and motor disturbances
Range 0–144, high score indicates frequent and severe symptoms
The distress scale assess caregiver distress associated with each neuropsychiatric symptom, range 0–60, high score indicate distressing symptoms
Change in total score and change in score for each item Mean, and proportion above clinical significant score Mean difference in total and item specific score over the 6-month intervention period summarized for the three intervention groups compared to mean difference in score summarized for the control groupsa
Mean difference in total and item specific score over the follow-up period in 6-month intervals stratified by time from end of interventionb
 Cohen-Mansfield Agitation Inventory (CMAI) (75, 76) Agitation in dementia 29 items rated from 1 to 7 for proxy assessment frequency of agitated behavior
Range 29–203, high score indicates frequent agitation
Change in total score Mean and proportion above clinical significant score Mean difference in score over the 6-month intervention period summarized for the three intervention groups compared to mean difference in score summarized for the control groupsa
Mean difference in score over the follow-up period in 6-month intervals stratified by time from end of interventionb
 Cornell Scale for Depression in Dementia (CSDD) (77) Depression in dementia 19 items rated from 0 to 2 for proxy assessment of depressive symptoms in dementia
Range 0–38
Score ≥ 8 indicates depression; ≥ 12 indicates moderate–severe depression
Change in total score Mean and proportion above clinical significant score Mean difference in score over the 6-month intervention period summarized for the three intervention groups compared to mean difference in score summarized for the control groupsa
Mean difference in score over the follow-up period in 6-month intervals stratified by time from end of interventionb
 Geriatric Depression Scale (GDS) (78) Depression in old age 30 items rated 0 or 1, for proxy assessment of depressive symptoms in the elderly population
High score indicates high symptom load
Change in total score Mean Mean difference in score over the 6-month intervention period summarized for the three intervention groups compared to mean difference in score summarized for the control groupsa
Mean difference in score over the follow-up period in 6-month intervals stratified by time from end of interventionb
 Activities of Daily Living, Instrumental (I-ADL) (76) Functional level for instrumental activities Eight items for proxy assessment of use of telephone, shopping, economy, public transport and household
Range 8–31, high score indicates poor functioning
Change in total score Mean Mean difference in score over the 6-month intervention period summarized for the three intervention groups compared to mean difference in score summarized for the control groupsa
Mean difference in score over the follow-up period in 6-month intervals stratified by time from end of interventionb
 Activities of Daily Living, Personal (P-ADL) (79) Functional level for personal activities Six items rated 1–5 for proxy assessment of personal activities such as toileting, grooming, dressing, transfer and eating
Range 6–30, high score indicates poor functioning
Change in total score Mean Mean difference in score over the 6-month intervention period summarized for the three intervention groups compared to mean difference in score summarized for the control groupsa
Mean difference in score over the follow-up period in 6-month intervals stratified by time from end of interventionb
 General Medical Health Rating Scale (GMRH) (85) Medical comorbidity in dementia 4-point Likert scale assessing presence and severity of medical conditions, scored by the interviewer
High score indicates high comorbidity burden
Ratings on the Likert scale transformed to numeric scale to estimate change in total score Mean Mean difference in score over the 6-month intervention period summarized for the three intervention groups compared to mean difference in score summarized for the control groupsa
Mean difference in score over the follow-up period in 6-month intervals stratified by time from end of interventionb
 Mobilization–Observation–Behavior–Intensity Dementia Pain Scale (MOBID-2) (80–84) Pain in dementia 10 items rated 0–10 for proxy-rated assessment of pain related to the muscle–skeletal system and pain that might be related to internal organs, head and skin
High score indicates frequent and severe pain
Change in overall score and change in score for each item Mean Mean difference in score over the 6-month intervention period summarized for the three intervention groups compared to mean difference in score summarized for the control groupsa
Mean difference in score over the follow-up period in 6-month intervals stratified by time from end of interventionb
 Clinical Global Impression of Change (CGIC) (86) Clinical meaningful change Quantifies and tracks patient progress and treatment response on a scale from 1 to 7, scored by the interviewer
High score indicates worsening
Change in overall score Mean and proportion with worsening, no change and improvement Mean difference in score over the 6-month intervention period summarized for the three intervention groups compared to mean difference in score summarized for the control groupsa
Mean difference in score over the follow-up period in 6-month intervals stratified by time from end of interventionb
  1. All assessment will be made by research personal or affiliated staff in the municipalities during home visits with the person with disability (PWD) and the caregiver
  2. aIntervention groups: group 1 (red), t1–t2; group 2 (yellow), t2–t3; group 3 (green), t3–t4. Control groups: (t1–t2 + t2–t3) (see Fig. 2a)
  3. bGroup 1 (red): three 6-month periods, t2–t3, t3–t4 and t4–t5. Group 2 (yellow): two 6-month periods, t3–t4 and t4–t5. Group 3 (green): one 6-month period, t4–t5 (see Fig. 2a)