The usability and effectiveness of connecting technology on physical and psychosocial functioning of cardiovascular disease rehabilitees in usual rehabilitation

• Register: ISRCTN
• Last refreshed on: 24 April 2023
• Main ID: ISRCTN61225589
• Date of registration: 06/01/2017
• Prospective Registration: No
• Primary sponsor: University of Jyväskylä
• Public title: The usability and effectiveness of connecting technology on physical and psychosocial functioning of cardiovascular disease rehabilitees in usual rehabilitation
• Scientific title: The usability and effectiveness of connecting technology on physical activity, physical and psychosocial functioning, participation and quality of life of cardiovascular disease rehabilitees - a cluster randomized trial with six month follow up in usual rehabilitation
• Date of first enrolment: 21/09/2015
• Target sample size: 60
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN61225589
• Study type: Interventional
• Study design: Parallel cluster randomized trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Finland

Contacts

• Name: Tuulikki Sjögren

Key inclusion & exclusion criteria

Inclusion criteria:
1. Coronary artery disease rehabilitee with basic skills for using internet
2. Adults and elderly, no restrictions in age

Exclusion criteria: Musculoskeletal diseases, cognitive diseases or problems with memory that clearly limit functional capacity

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Coronary artery disease rehabilitation (chronic phase)
Circulatory System

Intervention(s)

The participants consist of 60 volunteer cardiovascular disease rehabilitees from six rehabilitation courses in a 12-month coronary artery disease rehabilitation intervention. Three of the courses are randomized to a usual rehabilitation group and the other three courses use connecting technology (Fitbit Zip® accelerometer and Movendos m-coach internet application) during usual rehabilitation.

12-month usual multidisciplinary rehabilitation consists of three five-day inpatient face-to-face rehabilitation periods in the rehabilitation center (at baseline, 6 months and 12 months) and an outpatient period between inpatient rehabilitation sessions (2 x 6 months). Quantitative data is collected with physical and psychosocial questionnaires and physical measurements. The effectiveness of the intervention on physical and psychosocial functioning are analyzed using linear mixed models. Cluster-specific methods are justified by the composition of inpatient courses, when groups rather than individuals are randomized. Qualitative data is collected with focus group interviews (baseline, 6 month and 12 months). The qualitative data is analyzed by inductive content analysis.

Primary Outcome(s)

1. Objective physical activity (total physical activity: frequency, duration, intensity and patterns of movement [and different combinations of outcomes]), measured using Fitbit Zip® accelerometer. This study uses five times one-week recall during the intervention (baseline, 3, 6, 9 and 12 months) and once during the follow up period (6 months).
2. Subjective physical activity (vigorous and moderate physical activity and walking [and different combinations of outcomes]), measured using the International Physical Activity Questionnaire (IPAQ) three times during the intervention period (baseline, 6 months and at 12 months) and once during the follow up period (6 months).

Secondary Outcome(s)

1. Physical functioning:
1.1. Cardiorespiratory fitness, evaluated using submaximal level of functional capacity by using the 6-minute walking test. Outcome measures are: maximal oxygen uptake, heart rate, walking pace, Borg scale 0-10 (ATS Statements: Guidelines for the Six-Minute Walk Test 2002). Schedule of measurements is three times during intervention period (baseline, 6 months and at 12 months) and once during the follow-up period (6 months).
1.2. Body composition. measured by weight (kg), height (cm), body mass index (BMI) and waist circumference (cm). Schedule of measurements is three times during intervention period (baseline, 6 months and at 12 months) and once during the follow-up period (6 months).
2. Quality of life, measured using The World Health Organization Quality of Life-assessment (WHOQOL-BREF). WHOQOL-BREF domains are physical health, psychological, social relationships, environment (WHOQOL Group 1996, WHOQOL Group 1998, Skevington ym. 2004). Schedule of measurements is three times during the intervention period (baseline, 6 months and at 12 months) and once during the follow-up period (6 months).
3. Adherence to treatment, measured by the times of log-in to the Movendos m-coach internet application and the amount of exercise according to the data that Movendos m-coach software has collected. The data is collected at the end of the 12-month intervention.
4. Technology acceptance, evaluated using a questionnaire (modified by Venkatesh & Bala 2008) with sections “perceived ease of use” and “perceived usefulness”. The data is collected at the end of the 12-month intervention.
5. Cost-effectiveness of connecting technology, evaluated based on the differential between the common benefits and costs. Outcomes are related to direct time-related costs of rehabilitee, rehabilitation employees and management of the rehabilitation center. The main health-related outcomes are related to physical activity and quality of life. Cost-effectiveness is evaluated during the intervention period (12 months) and during the follow-up period (6 months).
6. Expectations and attitudes towards the use of connecting technology in rehabilitation, evaluated by the data from group interviews. Interviews are performed three times during the intervention period (baseline, 6 months and at 12 months) and once during the follow-up period.

Secondary ID(s)

D number 44/26/2015

Source(s) of Monetary Support

Kela

Ethics review

Status:
Approval date:
Contact:

Ethics committee of the Central Finland Health Care District, 06/10/2015, ref: 44/26/2015

Results

• Date Completed: 30/11/2017