NCT03339011

Brief Summary

Physical inactivity is a major risk behaviour with a potential for causing premature death, particularly among people with mobility limitations, such as knee osteoarthritis. Digital motivational interventions (such as SMS) can motive to a healthy behaviour including increased physical activity. The purpose of this study is to investigate if motivational text messages following an exercise intervention to improve mobility limitations will change the physical activity level in patients with knee osteoarthritis. This study is designed as pilot randomized controlled trial, with equal randomization (1:1). Eligible participants will be randomised into one of two groups (intervention or control) after completing their baseline measurements. The intervention group will receive weekly motivational text messages and the control group will not receive any attention from the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable knee-osteoarthritis

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

November 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

November 14, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2018

Completed
Last Updated

August 2, 2018

Status Verified

August 1, 2018

Enrollment Period

9 months

First QC Date

November 7, 2017

Last Update Submit

August 1, 2018

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in physical inactivity

    Physical inactivity is measured using an accelerometer based activity monitor. Physical activity is defined as time (in minutes) spent inactive, i.e. lying, sitting, standing during a day.

    6 weeks

Secondary Outcomes (3)

  • Change form baseline in the Knee Injury and Osteoarthritis Outcome Score (KOOS)

    6 weeks

  • Transition questionnaire (TRANS-Q) of perceived change in knee symptoms

    6 weeks

  • Self-reported change in physical inactivity

    6 weeks

Study Arms (2)

SMS text message

EXPERIMENTAL

The content of the text messages is developed based on recommendation and advice from the Danish Health Authority about the importance of regular daily physical activity. For 6 weeks, the text messages will be send three times per week, twice during the week days and once in the weekend, based on previous experience with SMS as motivation for chronic pain patients.

Behavioral: Motivational SMS text message

No intervention

NO INTERVENTION

No attention from the study

Interventions

Motivational SMS text messageBEHAVIORAL

Motivational text messages delivered to the participants' mobile phones. The text messages contain motivational text and advice on physical activity.

SMS text message

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≤18
  • Diagnosed with knee osteoarthritis
  • Owner of a smart phone or tablet
  • Have just finished an exercise program for knee osteoarthritis

You may not qualify if:

  • Not able to read and understand Danish
  • Any condition, which in the opinion of the investigator would put the subject at increased safety risk by participation, or otherwise make the subject unsuitable for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Parker Institute, Bispebjerg and Frederiksberg University Hospitals

Copenhagen, 2000, Denmark

Location

Related Publications (1)

  • Bartholdy C, Bliddal H, Henriksen M. Effectiveness of text messages for decreasing inactive behaviour in patients with knee osteoarthritis: a pilot randomised controlled study. Pilot Feasibility Stud. 2019 Sep 7;5:112. doi: 10.1186/s40814-019-0494-6. eCollection 2019.

    PMID: 31516729DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 7, 2017

First Posted

November 9, 2017

Study Start

November 14, 2017

Primary Completion

July 29, 2018

Study Completion

July 29, 2018

Last Updated

August 2, 2018

Record last verified: 2018-08

Locations

DK(1)