NCT03293303

Brief Summary

BACKGROUND: Older adults spend approximately 80% of their awake time in sedentary activities which represents 8 to 12 hours per day. In the past, numerous stand-alone exercise programs have been developed. However, it is challenging to persuade older adults to become and maintain physically active. Consequently, physical activity should be embedded in the daily life of older adults to reduce their sedentary time, prevent negative health consequences and facilitate ageing in place. INTERVENTION: 'Stay Active at Home' is not an additional, (classical) exercise programme; physical activity is integrated in usual home care. Healthcare professionals learn to engage older adults in daily life in order to improve their physical activity and reduce their sedentary time. For example, washing the upper body and face independently; changing the pillowcase, while professional changes bedcover; and motivating clients to join a dancing class at the community centre. AIM and DESIGN: The aim of this cluster randomised controlled trial is to provide evidence about the (cost-) effectiveness of 'Stay Active at Home' prior to dissemination and implementation of the programme. Alongside the trial an extensive process evaluation will be conducted.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

October 6, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2019

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

1.7 years

First QC Date

September 20, 2017

Last Update Submit

October 15, 2020

Conditions

Keywords

PreventionPhysical activitySedentary behaviourDaily activitiesHomecareNursingPrimary careOlder adultsFunction Focused CareReablementRestorative Care

Outcome Measures

Primary Outcomes (1)

  • Sedentary behaviour measured by ActiGraph GT3X+ (older adults)

    An accelerometer that measures sedentary time and physical activity by assessing the magnitude of the body's acceleration in terms of 'counts' per unit time.

    12 months

Secondary Outcomes (6)

  • Disabilities in ADL and IADL by Groningen Activity Restriction Scale (older adults)

    baseline and after 12 months

  • Physical activity by Short Physical Performance Battery (older adults)

    baseline and after 12 months

  • Major and minor depression by Patient Health Questionnaire-9 (older adults)

    baseline and after 12 months

  • Falls, 1 item 'How often did you fall during the last 6 months?' (older adults)

    baseline and after 6, 12 months

  • Health-related quality of life by EQ-5D-5L (older adults)

    baseline and after 6, 12 months

  • +1 more secondary outcomes

Study Arms (2)

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.

Behavioral: Stay Active at Home

Usual care

NO INTERVENTION

Second group of homecare professionals will get no training and their clients will receive usual homecare.

Interventions

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.

Stay Active at Home

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Receive home care services by the selected nursing teams
  • Age ≥65 years

You may not qualify if:

  • Terminal ill or bedbound
  • Serious cognitive or psychological problems
  • Not able to communicate in Dutch

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MeanderGroep Zuid-Limburg

Landgraaf, Limburg, Netherlands

Location

Related Publications (4)

  • Metzelthin SF, Rooijackers TH, Zijlstra GAR, van Rossum E, Veenstra MY, Koster A, Evers SMAA, van Breukelen GJP, Kempen GIJM. Effects, costs and feasibility of the 'Stay Active at Home' Reablement training programme for home care professionals: study protocol of a cluster randomised controlled trial. BMC Geriatr. 2018 Nov 13;18(1):276. doi: 10.1186/s12877-018-0968-z.

    PMID: 30424738BACKGROUND
  • Metzelthin SF, Zijlstra GA, van Rossum E, de Man-van Ginkel JM, Resnick B, Lewin G, Parsons M, Kempen GI. 'Doing with ...' rather than 'doing for ...' older adults: rationale and content of the 'Stay Active at Home' programme. Clin Rehabil. 2017 Nov;31(11):1419-1430. doi: 10.1177/0269215517698733. Epub 2017 Mar 14.

    PMID: 29050508BACKGROUND
  • Rooijackers TH, Metzelthin SF, van Rossum E, Kempen GIJM, Evers SMAA, Gabrio A, Zijlstra GAR. Economic Evaluation of a Reablement Training Program for Homecare Staff Targeting Sedentary Behavior in Community-Dwelling Older Adults Compared to Usual Care: A Cluster Randomized Controlled Trial. Clin Interv Aging. 2021 Dec 22;16:2095-2109. doi: 10.2147/CIA.S341221. eCollection 2021.

  • Rooijackers TH, Zijlstra GAR, van Rossum E, Vogel RGM, Veenstra MY, Kempen GIJM, Metzelthin SF. Process evaluation of a reablement training program for homecare staff to encourage independence in community-dwelling older adults. BMC Geriatr. 2021 Jan 6;21(1):5. doi: 10.1186/s12877-020-01936-7.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Gertrudis IJ Kempen, PhD

    Maastricht University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants (i.e., older adults will be blinded); it's not possible to blind the healthcare professionals.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A randomised controlled trial with 12 months follow-up will be conducted. In total, five homecare teams from MeanderGroep Zuid-Limburg and the local domestic support workers will be trained in 'Stay Active at Home' (intervention group). Another five homecare teams and domestic support workers will deliver usual care (control group). Both groups of professionals and their clients will be compared at baseline and after 6 and/or 12 months follow-up.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2017

First Posted

September 26, 2017

Study Start

October 6, 2017

Primary Completion

July 5, 2019

Study Completion

August 20, 2019

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

Individual participant data and data dictionaries that underlie the results reported in articles that are published within this project are available from the corresponding author on reasonable request after deidentification (text, tables, figures, and appendices).

Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE
Time Frame
Data will be available beginning 9 months and ending 36 months following article publication.
Access Criteria
Data will be available for researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to t.rooijackers@maastrichtuniversity.nl. To gain access, data requestors will need to sign a data access agreement.

Locations