Community-dwelling Older AdultsNCT02904889
Stimulating Engagement in Daily and Physical Activities Among Older Adults Receiving Homecare Services (Part of Basic Care Revisited)
A study testing Stay Active at Home in people with Community-dwelling Older Adults, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Most older adults want to stay at home for as long as possible. To reach this aim it is important to maintain their mobility and self-care abilities. However, many older adults are at risk to lose their abilities, as they have an inactive lifestyle. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Community-dwelling Older Adults
- What is being tested?
- Stay Active at Home
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ≥65 years
- Community-dwelling
- Indication for homecare
- ≥10 hours sedentary behaviour/day (measured with LASA vragenlijst questionnaire)
- Written informed consent
Who cannot join
- Terminal
- Serious cognitive or psychological problems
- Not able to speak Dutch
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stimulating Engagement in Daily and Physical Activities Among Older Adults Receiving Homecare Services: An Exploratory Trial (Part of Basic Care Revisited)
Most older adults want to stay at home for as long as possible. To reach this aim it is important to maintain their mobility and self-care abilities. However, many older adults are at risk to lose their abilities, as they have an inactive lifestyle. In this study, homecare professionals learn to motivate their clients to be more active in daily and physical activities. Examples of these activities are washing and dressing, household chores or going for a walk.
The primary aim of this exploratory study is to evaluate the implementation of the 'Stay Active at Home' program (process evaluation). The secondary aim is to get insight into the potential effectiveness of the program with regard to several primary and secondary outcomes measures (effect evaluation). The tertiary aim is to test the feasibility of the proposed study design.
- Conditions
- Community-dwelling Older Adults
- Being tested
- Stay Active at Home, Usual care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stay Active at HomeBehavioural
Stay Active at Home' aims to change the behaviour of community nurses and domestic support workers by offering them an intensive training programme. Subsequently, professionals are expected to deliver goal-oriented, holistic and person-centred services focusing on supporting older adults to maintain, gain or restore their competences to engage in physical and daily activities so that they can manage their everyday life as independently as possible.
Usual careOther
Homecare professionals will get no training and their clients will receive usual homecare.
| Study group | Role | What they receive |
|---|---|---|
| Stay Active at Home | Experimental | One group of homecare professionals receives a training programme. In this training they learn to motivate their clients to be more active in daily and physical activities. Receives: Behavioral: Stay Active at Home |
| Usual care | Active comparator | Second group of homecare professionals will get no training and their clients will receive usual homecare. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery (older adults)
Measured: after 6 months
Groningen Activity Restriction Scale (older adults)
Measured: after 6 months
Secondary outcomes (8)
Patient Health Questionnaire-9 (older adults)
Measured: baseline, after 6 and 9 months
EQ-5D-5L (older adults)
Measured: baseline, after 6 and 9 months
Healthcare utilisation questionnaire (older adults)
Measured: baseline, after 6 and 9 months
Self-efficacy and outcome expectation questionnaire (older adults and professionals)
Measured: baseline, after 6 and 9 months
Satisfaction with care, 1 item CQ index (older adults)
Measured: baseline, after 6 and 9 months
Falls, 1 item 'How often did you fall during the ... months?' (older adults)
Measured: baseline, after 6 and 9 months
LASA sedentary behaviour questionnaire (older adults)
Measured: baseline, after 6 and 9 months
Physical activity (actigraph, counts/minute, subsample older adults)
Measured: baseline, after 6 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-dwelling Older AdultsStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silke Metzelthin, Maastricht University Medical Center
- Investigators
- Gertrudis IJ Kempen, PhD, Study chair, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904889
- Sponsor's protocol ID
- ZonMw no. 520002003
- Status last verified
- Dec 2016
- First submitted
- 8 Sep 2016
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: data are avalailble upon request depending on specific circumstances
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulating Engagement in Daily and Physical Activities Among Older Adults Receiving Homecare Services: An Exploratory Trial (Part of Basic Care Revisited)
- ClinicalTrials.gov ID
- NCT02904889
- Acronym / sponsor ID
- ZonMw no. 520002003
- Conditions
- Community-dwelling Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most older adults want to stay at home for as long as possible. To reach this aim it is important to maintain their mobility and self-care abilities. However, many older adults are at risk to lose their abilities, as they have an inactive lifestyle. In this study, homecare professionals learn to motivate their clients to be more active in daily and physical activities. Examples of these activities are washing and dressing, household chores or going for a walk.
The primary aim of this exploratory study is to evaluate the implementation of the 'Stay Active at Home' program (process evaluation). The secondary aim is to get insight into the potential effectiveness of the program with regard to several primary and secondary outcomes measures (effect evaluation). The tertiary aim is to test the feasibility of the proposed study design.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stay Active at Home | Experimental | Behavioral: Stay Active at HomeOne group of homecare professionals receives a training programme. In this training they learn to motivate their clients to be more active in daily and physical activities. |
| Usual care | Active comparator | Other: Usual careSecond group of homecare professionals will get no training and their clients will receive usual homecare. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- ≥65 years
- Community-dwelling
- Indication for homecare
- ≥10 hours sedentary behaviour/day (measured with LASA vragenlijst questionnaire)
- Written informed consent
Key exclusion criteria (3 listed)
- Terminal
- Serious cognitive or psychological problems
- Not able to speak Dutch
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stay Active at HomeStay Active at Home' aims to change the behaviour of community nurses and domestic support workers by offering them an intensive training programme. Subsequently, professionals are expected to deliver goal-oriented, holistic and person-centred services focusing on supporting older adults to maintain, gain or restore their competences to engage in physical and daily activities so that they can manage their everyday life as independently as possible. | Behavioural | Stay Active at Home |
| Usual careHomecare professionals will get no training and their clients will receive usual homecare. | Other | Usual care |
Primary outcome
Short Physical Performance Battery (older adults)
Time frame: after 6 months
Groningen Activity Restriction Scale (older adults)
Time frame: after 6 months
8 secondary outcomes
Patient Health Questionnaire-9 (older adults)
Time frame: baseline, after 6 and 9 months
EQ-5D-5L (older adults)
Time frame: baseline, after 6 and 9 months
Healthcare utilisation questionnaire (older adults)
Time frame: baseline, after 6 and 9 months
Self-efficacy and outcome expectation questionnaire (older adults and professionals)
Time frame: baseline, after 6 and 9 months
Satisfaction with care, 1 item CQ index (older adults)
Time frame: baseline, after 6 and 9 months
Falls, 1 item 'How often did you fall during the ... months?' (older adults)
Time frame: baseline, after 6 and 9 months
LASA sedentary behaviour questionnaire (older adults)
Time frame: baseline, after 6 and 9 months
Physical activity (actigraph, counts/minute, subsample older adults)
Time frame: baseline, after 6 and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
- Individual participant dataSharing planned: Undecided. data are avalailble upon request depending on specific circumstances
Related trials for Community-dwelling Older Adults
Not yet recruiting
Motor Imagery and Turning Practice to Improve Mobility: Pilot Trial
Mobility Impairment, Community Dwelling Older Adults
Not yet recruiting
Comparative Effects of Exercises on Reactive Balance and Fall Risk in Community-Dwelling Older Adults
COMMUNITY-DWELLING OLDER ADULTS
Enrolling by invitationObservational study
Comorbidity, Cognition, Gait Speed, and Respiratory Muscle Strength in Older Adults
Geriatrics, Older Adults (60 - 85 Years Old)
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Not yet recruiting
Eccentric Exercise in Community-dwelling Older Adults
Ageing Well
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gertrudis IJ Kempen, PhD study chair
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stay Active at Home in people with Community-dwelling Older Adults, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (older adults) (time frame: after 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2017.