Clinical trial NCT03398642: Influence of Lifestyle Redesign® on Health, Social Participation, Leisure and Mobility of Older French-Canadians
Official title: Influence of Lifestyle Redesign® on Health, Social Participation, Leisure and Mobility of Older French-Canadians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community-dwelling Older Adults
Keywords: Occupational therapy
Health promotion
Life Style
Quality of life
Aging
Aged
Community participation
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Université de Montréal
name: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
name: Research Centre on Aging, CIUSSS de l'Estrie-CHUS
name: Université du Québec à Trois-Rivières
name: University of Sheffield
First posted: 2018-01-12
Enrollment: 16
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Detailed description: Study Design and Participants This pilot study used a mixed-method concurrent triangulation design including a pre-experimental component \[pre-test (T1), post-test (T2) and follow-ups (T3 and T4)\] and an exploratory descriptive qualitative clinical study with a sample of 16 community-dwelling older adults with and without disability. A sample size of 16 participants allowed detection of a standardized difference of 0.75 or greater between two means according to paired bilateral t tests based on a significance level of 5% and power of 80%. This difference was sufficient in a study that explored the influence of another intervention on leisure and life-space mobility. This sample size also allowed in-depth exploration and data saturation. Eligibility criteria were: 1) aged 65 and over, 2) no or mild (group 1) or moderate or severe (group 2) loss of autonomy, 3) normal cognitive functions, 4) living in a conventional or residential home for semi-independent seniors, and 5) French-speaking. Participants were recruited from a previous study of people attending a day hospital and day center in a Health and Social Services Centre (HSSC) in Quebec (Canada), and from people living in a residence. The Research Ethics Committee of the Eastern Townships HSSC approved the study (2015-488).

Data Collection Procedures Participants were recruited until the predetermined sample size (n=16+3, anticipating possible attrition) was reached. All participants signed an informed consent form and were met individually at home by a research assistant or occupational therapy student specially trained to administer the questionnaires. An experienced research assistant conducted the qualitative interviews. At T1, one sociodemographic and eight outcome questionnaires, four reported here and others elsewhere (Trépanier et al., in preparation), were administered in approximately 120 minutes. Following the six-month intervention period, participants answered the same outcome questionnaires (T2) and, about one month later, had a face-to-face semi-structured individual interview lasting about 90 minutes. All interviews were digitally audiotaped, transcribed and verified with respect to the wording used by participants. After the first few interviews, two authors (MB and ML) discussed and adjusted the questions for subsequent interviews. Finally, three (T3) and six (T4) months after the end of the intervention, participants answered the same questionnaires again.

Intervention In the present study, 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. The OT was also supervised on a weekly basis by an academic OT specializing in health promotion and clinical research, and having a good knowledge of the intervention (highly involved in the translation). This supervision allowed the OT to have regular feedback on her role and intervention. Weekly 2-hour group sessions were held over a six-month period between August 2015 and March 2016. 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. These meetings aimed to help participants integrate the group session content and engage in personalized meaningful activities. In the group with participants having moderate or severe loss of autonomy, assistance to the OT was provided by one or two volunteers during respectively group sessions or outings.

Outcome Variables and Tools Data on health, social participation, leisure and life-space mobility were collected with four questionnaires. The 36-item Short Form Health Survey (SF-36) comprises 36 items covering eight domains related to physical and mental health. The SF-36 has good psychometric properties and is widely used in research, including previous Lifestyle Redesign® studies. The Social Participation Scale estimates the frequency of participation in 10 community activities and has shown good internal consistency. The Leisure Profile assesses involvement in leisure activities, attitudes toward leisure, and difficulties that might influence leisure activities; it has acceptable interrater and test-retest reliability. The Life-Space Assessment (LSA) measures life-space mobility and, more specifically, the range, independence, and frequency of movement over the preceding four weeks. The LSA presents good construct validity with observed physical performance and self-reported function and good sensitivity to change. Finally, a semi-structured interview guide validated by 5 qualitative research experts and pretested was used to explore the effect of Lifestyle Redesign®. Examples of questions were: 'Tell me about your experience with the program'; 'If applicable, how have your activities changed as a result of the program?' and 'How did the program help you make this change?' Data Analysis The participants' sociodemographic characteristics and outcomes were analyzed using descriptive statistics. Scores were compared with the Friedman test followed by the Wilcoxon signed rank test but for all participants and, in an exploratory manner, for participants of each group separately. Because of the exploratory nature of this study and the influence of seasonal variations on Quebecers' health, social participation, leisure and mobility, changes at any of the post-intervention measurement times with a p value \< 0.05 were consider to be potentially attributable to the intervention. Interview transcripts underwent thematic content analysis using mix extraction grids. Themes that emerged from the interview content were organized and renamed according to the Human Development Model-Disability Creation Process, a model of human development and disability. The coauthor cocoded one-third of the data and closely supervised the analysis that underwent adjustement to reach a consensus. For parsimony with respect to the quantitative results, themes presented in this paper focus on health, social participation, leisure and mobility. Analyses were conducted using SPSS Statistics (v18) or NVivo (v10).

Eligibility criteria: Inclusion Criteria:

1. Aged 65 and over
2. Normal cognitive functions
3. Living in a conventional or residential home for semi-independent seniors
4. French-speaking -

Exclusion Criteria:

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

Primary outcomes:
measure: 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
timeFrame: Baseline, 6, 9, 12 months
Secondary outcomes:
measure: 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
timeFrame: Baseline, 6, 9, 12 months
measure: Leisure Profile, for the assessment of change in leisure, attitudes and limitations from before at 6, 9, and 12 months after the intervention
timeFrame: Baseline, 6, 9, 12 months
measure: 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
timeFrame: Baseline, 6, 9, 12 months
measure: Exploration of the influence of the French Lifestyle Redesign
timeFrame: About one month after the intervention
Other outcomes:
Locations:
Study officials:
affiliation: Université de Sherbrooke, Centre de recherche sur le vieillissement
name: Mélanie Levasseur
role: PRINCIPAL_INVESTIGATOR
References: