NCT06807060

Brief Summary

Ageing is associated with circadian rhythm sleep disorders, poor sleep at night, less physical activity and more time spent indoors, affecting the wellbeing of older adults. Their sleep and mood could benefit from daytime outdoor physical activity, exposure to daylight, better indoor lighting and sleep routines. However, maintaining or increasing one's physical activity can be challenging depending on individual behavioural conditions, e.g., having the physical and cognitive capacity (capability), finding the activity enjoyable and relevant to one's needs (motivation), and having a supportive social and physical environment (opportunity), such as a walk-friendly environment. To address these challenges, a complex behavioural intervention was developed. The intervention is delivered as a web-based course ('Light, activity and sleep in my daily life', LAS) that targets light-related behaviour, outdoor walking and sleep behaviour among community-dwelling older adults. This protocol describes a pilot case study aiming to evaluate the usability and usefulness of the LAS intervention, the intervention outcomes and whether changes to routines are sustained. Eligible intervention participants (target N=40) are Swedish-speaking adults (≥ 70 years), living in one-person households in apartments in four municipalities. Participants complete questionnaires assessing intervention outcome measures (e.g., quality of life), are interviewed about their daily routines, and wear an accelerometer which tracks activity and rest at the baseline. Participants then enrol in a 9-week course, including self-studies at home and four physical meetings at the senior citizen meeting point. Baseline measures are repeated after the course, at 3, 6 and 10 months after baseline. In addition, participants evaluate the intervention's usability and usefulness after the course at 3 months and are interviewed at 6 months after baseline about perceived enablers and inhibitors to daytime outdoor walking. Results will inform a subsequent larger case study focused on optimising the LAS intervention's content and delivery procedures to enable an intervention better integrated into municipal health promotion services/strategies. An anticipated long-term outcome is continued active ageing and independence.

Trial Health

77
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 quality-of-life

Timeline
4mo left

Started May 2024

Typical duration for not_applicable quality-of-life

Geographic Reach
1 country

4 active sites

Status
recruiting

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 Progress84%
May 2024Oct 2026

Study Start

First participant enrolled

May 15, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 4, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2026

Last Updated

February 4, 2025

Status Verified

January 1, 2025

Enrollment Period

2.4 years

First QC Date

January 24, 2025

Last Update Submit

January 31, 2025

Conditions

Keywords

Complex interventionBehavioural changeEnvironmental proactivityOlder adultsUsabilityQuality of LifeDaytime outdoor walking

Outcome Measures

Primary Outcomes (1)

  • Usability

    System Usability Scale score. The usability of the intervention, that is, if the online content is easy for the intervention participants to use, will be evaluated through a usability testing questionnaire (perceptions of complexity, integration of functions, consistency). Following published instructions on scoring of the 10-item System Usability Scale (SUS), a total usability score will be calculated ranging from 0 to 100. Higher SUS scores indicate greater usability. Based on empirical evaluations of the SUS, a SUS score below 50 indicates usability difficulties, while scores in the 70s and 80s are considered promising.

    At one timepoint: 3 months after baseline

Secondary Outcomes (8)

  • Mood

    At four timepoints: baseline, 3, 6 and 13 months after baseline

  • Sleep quality

    At four timepoints: baseline, 3, 6 and 13 months after baseline

  • Behavioural skill

    At four timepoints: baseline, 3, 6 and 13 months after baseline

  • Quality of life

    At four timepoints: baseline, 3, 6 and 13 months after baseline

  • Sleep (activity and rest patterns)

    At four timepoints: baseline, 3, 6 and 13 months after baseline. Duration of time over which each participant is assessed: 7 days (not used during shower)

  • +3 more secondary outcomes

Other Outcomes (2)

  • Computer anxiety

    At two timepoints: baseline and 3 months after baseline

  • Lighting quality

    At two timepoints: baseline and 3 months after baseline

Study Arms (1)

Intervention

EXPERIMENTAL

All participants receive the same intervention, including noninvasive approaches (both education and behavioural).

Behavioral: 'Light, activity and sleep in my daily life' intervention

Interventions

The intervention is complex in that it considers multiple factors (e.g., light-related behaviour, physical activity and sleep behaviour) and multiple components (e.g., cognitive goal setting and implementation). The intervention is delivered as a web-based course on a digital learning platform. Course material is placed in nine modules covering electric lighting, daylight, physical activity outdoors and sleep. Besides online material, the course includes a test kit containing light bulbs, a sleep mask, a checklist for the room inventory, a cap, a notebook, and a sleep diary. The purpose of the test kit is to encourage experimentation and provide handouts and printed copies to facilitate the completion of assignments.

Intervention

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • aged 70 and over, ambulatory and sighted,
  • Swedish speaking,
  • living independently in one-person households in ordinary apartments and
  • receiving no or limited home care services.

You may not qualify if:

  • Study participants will be excluded if they have any condition that makes it difficult to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Gothenburg Municipality

Gothenburg, Sweden

RECRUITING

Jönköping Municipality

Jönköping, Sweden

NOT YET RECRUITING

Lund Municipality

Lund, Sweden

ACTIVE NOT RECRUITING

Malmö Municipality

Malmo, Sweden

ACTIVE NOT RECRUITING

Related Publications (1)

  • Gerhardsson KM, Hassan M, Tornberg AB, Schmidt SM. Usability and feasibility of an online intervention for older adults to support changes to routines and the home ('Light, activity and sleep in my daily life'). BMC Public Health. 2024 Oct 14;24(1):2808. doi: 10.1186/s12889-024-20309-y.

    PMID: 39402489BACKGROUND

MeSH Terms

Interventions

LightExerciseSleep

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaOptical PhenomenaRadiationRadiation, NonionizingMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNervous System Physiological Phenomena

Central Study Contacts

Steven M Schmidt, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2025

First Posted

February 4, 2025

Study Start

May 15, 2024

Primary Completion (Estimated)

October 16, 2026

Study Completion (Estimated)

October 16, 2026

Last Updated

February 4, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations