Telehealth Intervention Involving the HEARTS Technical Package and the Use of an Activity Monitor to Increase Physical Activity Level Post-stroke: a Feasibility Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Federal University of Minas Gerais
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Feasibility of intervention (perceived effectiveness)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
Objectives: The aim of this feasibility randomized controlled trial (RCT) study is to investigate whether the theoretically informed telehealth intervention involving the HEARTS Technical Package and the use of an activity monitor to increase physical activity level post-stroke is feasible and to estimate the parameters for conducting a fully powered RCT.
Design: A Phase 1 feasibility RCT study with blinded assessment will assign eligible participants to experimental or control group. Participants in both groups will undergo a theoretically informed telehealth intervention based on the HEARTS technical package (a face-to-face session and telephone call follow-up). The experimental group will have additional use of the Mi Band 7® Smartwatch activity monitor. For both groups, the intervention will last for 12 weeks. The feasibility outcomes will be identified considering the different phases of conducting the study. A trained researcher, blinded to the group allocation, will collect the sociodemographic, anthropometric, and clinical outcomes, in a university laboratory setting.
Study Outcomes: Feasibility of recruitment, intervention, and measurement, and clinical outcomes.
Conclusions: Results from this feasibility RCT study will inform on the design and sample required for a fully powered RCT with a similar aim.
Detailed Description
Standard Operating Procedures: A non-probabilistic sample will be recruited from the community. Recruitment strategies include: referrals (e.g, phone numbers obtained from other research projects and university extension programs) and advertisements (e.g. physical folders distributed in public places, and electronic pamphlets published on social media). All subjects will be informed about the study procedures and will provide written consent. The feasibility outcomes will be identified considering the different phases of conducting the study. A trained researcher, blinded to the group allocation, will collect the sociodemographic, anthropometric, and clinical outcomes, in a university laboratory setting. Two independent examiners, blinded to the group allocation, will enter the data into a statistical software package, verify any missing or apparently wrong values. Original paper forms will be kept in a secure place. Electronic files will be available only to the research team. Analysis will be carried-out by a researcher, blinded to the group allocation. All individuals will receive an identification code to ensure anonymity. Statistical analyzes: All analyzes will be performed using SPSS (SPSS Inc., Chicago, IL, USA). Descriptive statistics will be calculated for all outcomes. The effect sizes will be calculated to determine the magnitude of within-groups and between-groups comparisons. The level of significance will be set at 5% and adjusted for multiple comparisons.
Investigators
Christina Danielli Coelho de Morais Faria
Doctor
Federal University of Minas Gerais
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of stroke for more than six months;
- •≥18 years of age;
- •Be rated as "Inactive" according to Human Activity Profile (HAP);
- •Provide medical approval to practice physical activity.
Exclusion Criteria
- •Positive screening test for possible cognitive alterations;
- •Pain or other adverse health condition that compromises the performance of the proposed intervention program, such as vestibular disorders, severe arthritis or any other diagnosis of disease of the nervous system.
Outcomes
Primary Outcomes
Feasibility of intervention (perceived effectiveness)
Time Frame: At post-intervention (week-12).
It will be determined by the following question: "Comparing how it was before you carried out the intervention and now, do you think that your ability to perform routine physical activity is: much worse, moderately worse, a little worse, the same, a little better, moderately better, or very better?".
Feasibility of intervention (attendance)
Time Frame: At allocation and post-intervention (week-12).
It will be determined by the ratio between the total number of sessions performed and the total number of sessions offered.
Feasibility of intervention (retention)
Time Frame: At allocation and post-intervention (week-12).
It will be determined by the ratio between the total number of individuals who completed the proposed intervention program and the total number of individuals who started the proposed intervention program.
Feasibility of intervention (follow-up of individuals)
Time Frame: At allocation, post-intervention (week-12), and one month after the end of the intervention (week-16).
It will be determined the ratio between the total number of individuals who remained in the same group to which they were initially allocated until follow-up and the total number of individuals who were allocated.
Feasibility of intervention (safety)
Time Frame: During the intervention (12 weeks) and follow-up (4 weeks).
It will be determined by the number and reasons of adverse events (e.g. pain, falls, hospitalization, and death) identified during the period of intervention and follow-up of the individual.
Feasibility of measurement
Time Frame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).
It will be determined by the percentage of clinical outcomes measured (ratio between the number of clinical outcomes measured and the number of clinical outcomes proposed to be measured), and the percentage of participants who filled-out the diary (ratio between the number of individuals who filled-out the diary and the number of individuals who started the proposed intervention program).
Feasibility of recruitment
Time Frame: At enrolment and allocation.
It will be determined by the ratio between the total number of eligible individuals (EI) and the total number of screened individuals (SI) (measure=EI/IS), and by the ratio between the total number of eligible individuals (EI) and the total number of recruited individuals (RI) (measure=EI/RI).
Secondary Outcomes
- Physical activity level(At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).)
- Self-efficacy for physical activity(At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).)
- Health-related quality of life(At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).)
- Number of post-stroke individuals who became physically active(At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).)
- Systolic and diastolic blood pressure(At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).)
- Lifestyle-related energy consumption(At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).)