Table 1. Study data collected, timing of data collection points, and purpose of data item.
| For the person with dementia | |||
|---|---|---|---|
| Construct | Measure | Time points (months) | Purpose |
| Age | Date of birth | 0 | Describe population |
| Gender | Categorical | 0 | Describe population |
| Dementia diagnosis | Yes/No | 0 | Describe population |
| Dementia type | Categorical | 0 | Describe population |
| Years living with dementia diagnosis | Years | 0 | Describe population |
| Living arrangement | Categorical | 0 | Describe population |
| Education level | Categorical | 0 | Describe population |
| Medical history | Categorical | 0 | Describe population |
| Physical capacity (self-report/observed) | Categorical | 0,6,12 | Describe population |
| Use of a walking aid indoors/outdoors | Yes/No | 0,6,12 | Describe population |
| Falls | Number • At baseline, the person living with dementia will be asked to recall falls over the last 6-months. • For the following 12-months, the person will complete a falls diary that will prospectively capture the number of falls. |
0,6,12 | Describe population and analysis of economic efficiency |
| Falls with injury | Number and open text • At baseline, the person living with dementia will be asked to recall falls and falls injuries, over the last 6-months. • For the following 12-months, the person will complete a falls diary that will prospectively capture the number and injuries from falls. |
0,6,12 | Describe population and analysis of economic efficiency |
| Outcome measures for the person with dementia | |||
| Program acceptability | Is the “Changing the Focus” program suitable for you? • Yes/no/unsure Is the “Changing the Focus” program adequate to meet your needs? • Yes/no/unsure |
6,12 | Primary outcome |
| Program acceptability | Semi-structured interview | 6 (or at the time of withdrawal) | Primary outcome for implementation evaluation |
| Total physical activity time / week | Active Australia Survey, time and frequency of physical activity in the preceding week (or most recent “typical” week in the preceding month if the preceding week was not typical for amount of physical activity (e.g. acute health condition) | 0, 6,12 | Primary outcome |
| Program participation: Sustained participation in “Changing the Focus” | Proportion • The proportion of people living with dementia continuing with their selected program at 12-months |
12 | Primary outcome |
| Physical activity: New or modified (e.g increased dosage) of physical activity options undertaken as part of the “Changing the Focus” program | Physical activity program and time spent Recorded in exercise diary prospectively |
6,12 | Describe population, secondary outcome |
| Life space | Life Space Assessment-Cognitive Impairment (LSA-CI) questionnaire | 0,6,12 | Describe population, secondary outcome |
| Dynamic balance | Step test for L leg stepping and R leg stepping |
0,6,12 | Describe population, secondary outcome |
| Endurance | 2-min walk test | 0,6,12 | Describe population, secondary outcome |
| Leg strength | 30-second sit-to-stand | 0,6,12 | Describe population, secondary outcome |
| Functional mobility | Time-Up-and-Go-test | 0,6,12 | Describe population, secondary outcome |
| Cognition | Mini Mental State Examination | 0,6,12 | Describe population, secondary outcome |
| Social connectedness | Lubben Social Network Scale-6 (LSNS-6) | 0,6,12 | Describe population, secondary outcome |
| Physical activity enjoyment | Physical Enjoyment Scale PACES-8 | 0,6,12 | Describe population, secondary outcome |
| Activities of daily living | KATZ Activity of Daily Living Index | 0,6,12 | Describe population, secondary outcome |
| Impact on care-partners | Zarit Carer Burden Scale | 0,6,12 | Describe population, secondary outcome |
| Health-related quality of life | EQ-5D-5L | 0,6,12 | Describe population, secondary outcome and analysis of economic efficiency |
| Other adverse events | Number and event type (Recorded in falls diary for the last 6-months) |
6,12 | Describe population, secondary outcome |
| Program implementation cost | Customised survey: • Implementation and running of physical activity and dementia referral pathway, training of physical activity personnel and participant costs for program access. |
1,2,3,4,5,6,7,8,9,10,11,12 | Describe population and analysis of economic efficiency |
| Cost data (for the person with dementia) | Customised survey: Support from informal and formal care-partners, health care utilisation, pharmaceuticals, and opportunity costs. • The person living with dementia (with support from their care-partner) will be asked to recall support and health care utilisation over the last 6-months |
0,6,12 | Describe population and analysis of economic efficiency |
| Effect cost | • Falls and fall injuries (only for the person living with dementia) • Quality of life (both the person living with dementia and their care-partner) |
0,6,12 | Describe population and analysis of economic efficiency |
| Outcome of the shared decision process | • Type and amount of physical activity per week they currently do • Physical activity program(s) the person (and/or the care-partner if applicable) decided to take part in • Physical activity goal • Factors influencing the person’s choice |
0 | Describe population and guide the physical activity program, referral pathways and ongoing support required |
| Review of physical activity program the person is undertaking | Open text | 6,12 | Describe population and guide the physical activity program, referral pathways and ongoing support required |
| Review of physical activity goal/s that were set | Open text | 6,12 | Describe population and guide the physical activity program, referral pathways and ongoing support required |
| Achievement of physical activity goal/s relative to their expectation | Categorical | 6,12 | Describe population and guide the physical activity program, referral pathways and ongoing support required |
| For the care-partner of the person with dementia | |||
| Construct | Measure | Time points (months) | Purpose |
| Age | Date of birth | 0 | Describe population |
| Gender | Categorical | 0 | Describe population |
| Relationship to the person | Categorical | 0 | Describe population |
| Living with the person | Yes/No | 0 | Describe population |
| Years caring for the person | Years | 0 | Describe population |
| Past experience with assisting the person with physical activity participation | Yes/No | 0 | Describe population |
| Physical activity program/s they have helped the person with | Open text | 0 | Describe population |
| Health related quality of life | EQ-5D-5L | 0,6,12 | Describe population and analysis of economic efficiency |
| Program acceptability | Is the “Changing the Focus” program suitable for you as a care-partner? • Yes/no/unsure Is the “Changing the Focus” program adequate to meet your needs as a carer? • Yes/no/unsure |
6,12 | Primary outcome |
| Program acceptability | Semi-structured interview | 6 (or at the time of withdrawal) | Primary outcome for implementation evaluation |
| For referrers of the person with dementia participating in “Changing the Focus” | |||
| Construct | Measure | Time points (months) | Purpose |
| Program acceptability | Semi-structured interview | 1–2 | Primary outcome for implementation evaluation |
| For physical activity providers of the person with dementia participating in “Changing the Focus” | |||
| Construct | Measure | Time points (months) | Purpose |
| Program acceptability | Semi-structured interview | 6 | Primary outcome for implementation evaluation |