NCT03398642

Brief Summary

To address population aging, health professionals, including occupational therapists, need to engage in effective interventions. The preventive occupational therapy intervention called Lifestyle Redesign® empowers older adults to regularly perform healthy and fulfilling activities. Lifestyle Redesign® has been shown to benefit physical and mental health and be cost-effective. This pilot study explored the influence of Lifestyle Redesign® on older French- Canadians' health, social participation, leisure and mobility. Method: A mixed-method design was used with 16 participants (10 women) aged 65-90 (76.4±7.6 y), 10 without and 6 with disabilities. Health, social participation, leisure and mobility questionnaires were administered before and after the 6-month intervention, as well as 3 and 6 months post-intervention. Semi-directed interviews were also conducted.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

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

Study Start

First participant enrolled

July 9, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 12, 2018

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

11 months

First QC Date

November 7, 2017

Last Update Submit

January 15, 2018

Conditions

Keywords

Occupational therapyHealth promotionLife StyleQuality of lifeAgingAgedCommunity participation

Outcome Measures

Primary Outcomes (1)

  • 36-item Short Form Health Survey (SF-36) version 2, for the assessment of changes in physical and Mental Health from before at 6, 9 and 12 months after the intervention

    Full scale name: 36-item Short Form Health Survey (SF-36) version 2. Construct: The SF-36v2® assesses the health-related quality of life (HRQOL). Scale ranges: 0-100 for the scoring of eight health domains: (1-Physical Functioning, 2-Role Physical, 3-Bodily Pain, 4-General Health, 5-Vitality, 6-Social Functioning, 7-Role Emotional, 8-Mental Health) and of the Physical Component Summary (PCS) and Mental Component Summary (MCS), which can be calculated when seven scale scores are available and, for the PCS, when the Physical Functioning scale is not missing and for the MCS, when the Mental Health scale is not missing. A unique scoring algorithm is apply to the calculation of the summary scores depending upon which particular scale score is missing from the eight scale profiles. Higher score indicates better health.

    Baseline, 6, 9, 12 months

Secondary Outcomes (4)

  • Social Participation Scale, for the assessment of change in the frequency of participation in ten community activities from before at 6, 9 and 12 months after the intervention

    Baseline, 6, 9, 12 months

  • Leisure Profile, for the assessment of change in leisure, attitudes and limitations from before at 6, 9, and 12 months after the intervention

    Baseline, 6, 9, 12 months

  • French-Canadian version of Life-Space Assessment, for the assessment of change in range, independence and frequency of movement in the 4 last weeks from before at 6, 9 and 12 months after the intervention

    Baseline, 6, 9, 12 months

  • Exploration of the influence of the French Lifestyle Redesign

    About one month after the intervention

Study Arms (1)

French Lifestyle Redesign

EXPERIMENTAL

16 older adults, 10 without and 6 with disabilities, participated to weekly 2-hour group sessions, including outings, and monthly 1-hour individual sessions led by a occupational therapist over 6-month period and promoting healthy lifestyle and involvement in meaningful activities.

Behavioral: French Lifestyle Redesign

Interventions

Lifestyle Redesign® is a preventive occupational therapy intervention designed to promote meaningful and healthy activities. The French-Canadian Lifestyle Redesign® intervention was led by an occupational therapist (OT) who took the University of Southern California 6-hour online introductory training course and was supervised on a weekly basis. Weekly 2-hour group sessions were held over a six-month period.These sessions were based on 12 modules (e.g. occupation, health and aging; transportation and occupation) from the 2nd edition of the Lifestyle Redesign® Manual and involved didactic presentations, peer exchanges, reflective exercises, direct experience and personal exploration. Every month, one group outing was targeted and individual meetings with the OT were planned.

French Lifestyle Redesign

Eligibility Criteria

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

You may qualify if:

  • Aged 65 and over
  • Normal cognitive functions
  • Living in a conventional or residential home for semi-independent seniors
  • French-speaking -

You may not qualify if:

  • Moderate or severe cognitive impairment \[score \< 17 Adult Lifestyles and Function Interview-Mini-Mental State Examination (ALFI-MMSE)\]
  • Moderate or severe language impairment -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Mélanie Levasseur

    Université de Sherbrooke, Centre de recherche sur le vieillissement

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

November 7, 2017

First Posted

January 12, 2018

Study Start

July 9, 2015

Primary Completion

May 27, 2016

Study Completion

November 9, 2016

Last Updated

January 17, 2018

Record last verified: 2018-01