NCT02904889

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

September 26, 2017

Status Verified

December 1, 2016

Enrollment Period

10 months

First QC Date

September 8, 2016

Last Update Submit

September 25, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Short Physical Performance Battery (older adults)

    after 6 months

  • Groningen Activity Restriction Scale (older adults)

    after 6 months

Secondary Outcomes (8)

  • Patient Health Questionnaire-9 (older adults)

    baseline, after 6 and 9 months

  • EQ-5D-5L (older adults)

    baseline, after 6 and 9 months

  • Healthcare utilisation questionnaire (older adults)

    baseline, after 6 and 9 months

  • Self-efficacy and outcome expectation questionnaire (older adults and professionals)

    baseline, after 6 and 9 months

  • Satisfaction with care, 1 item CQ index (older adults)

    baseline, after 6 and 9 months

  • +3 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

ACTIVE COMPARATOR

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

Other: Usual care

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

Homecare professionals will get no training and their clients will receive usual homecare.

Usual care

Eligibility Criteria

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

You may qualify if:

  • ≥65 years
  • Community-dwelling
  • Indication for homecare
  • ≥10 hours sedentary behaviour/day (measured with LASA vragenlijst questionnaire)
  • Written informed consent

You may not qualify if:

  • Terminal
  • Serious cognitive or psychological problems
  • Not able to speak Dutch

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MeanderGroep Zuid-Limburg

Kerkrade, Limburg, Netherlands

Location

Study Officials

  • Gertrudis IJ Kempen, PhD

    Maastricht University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 19, 2016

Study Start

September 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

September 26, 2017

Record last verified: 2016-12

Locations