Effectiveness of a Mobile App–Based (OASapp) Intervention Among Older Adults Stroke Survivors
| ISRCTN | ISRCTN12147140 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12147140 |
| Secondary identifying numbers | Linyan K2022-003-01, Yu2022033, Lunshen 2022-10 |
- Submission date
- 15/12/2022
- Registration date
- 20/12/2022
- Last edited
- 21/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Globally, stroke remained the second-leading cause of death after ischaemic heart disease and the third adult disability factor. Compliance with prescription medication is critical to prevent recurrence and other adverse outcomes of stroke after the first stroke has been controlled. However, medication adherence in stroke survivors is problematic. In line with recent changes in technology, smartphone applications (Apps) are increasingly being used to improve health in a number of areas. However, little is known about the use of Apps among elderly stroke survivors.
The purpose of this study is to evaluate the effectiveness of a Mobile App–Based (OASapp) Intervention Among Older Adults Stroke Survivors on medication adherence, medicine beliefs, and health literacy on stroke and blood pressure.
Who can participate?
Older adults Stroke survivors who meet the inclusion-exclusion criteria
What does the study involve?
Participants will be randomly allocated to the intervention group (which received OASapp and standard carer) or control group (which received only standard carer). The intervention group will be provided with a detailed explanation of the OASapp in person by the project team leader and will be asked to utilize the app daily during a three-month period and receive one push notification each day at 19:00-21:00, with helpful self-care management tips. For the control group, they will not receive the app or any material included in the app during the study period. However, they will get access to the app after the 3-month trial.
What are the possible benefits and risks of participating?
This study’s findings may give a whole picture of the effectiveness of the OASapp. It can also serve as an eye-opener for HCP, policy-makers, and the government, to increase availability of disease management techniques to endorse better stroke management. The utilization of mobile app technology improves barriers to healthcare access, improves patient medication adherence, and increases patient exposure to self-care management techniques.
The risks involved in this study are minimal, which means they are equal to the risks you would encounter in everyday life.
Where is the study run from?
Three major general tertiary hospitals in Chenzhou, China: affiliated hospital of Xiangnan University, Chenzhou No. 1 People’s Hospital, and Chenzhou Third People’s Hospital.
When is the study starting and how long is it expected to run for?
August 2021 to September 2023
Who is funding the study?
This work is supported by a special fund for young key teachers in Hunan Province, China (Xiangjiaotong (2021) 29) and the Hunan University Students’ Innovation and Entrepreneurship Training Project (Xiangjiaotong (2022) 174 -4315).
Who is the main contact?
Wenjing Cao, caowenjing@student.usm.my
Contact information
Principal Investigator
Renmin Road
Chenzhou
423000
China
 ORCID ID |
0000-0002-3488-2430 |
|---|---|
| Phone | +86 17373529520 |
| 1435832421@qq.com |
Scientific
School of Health Sciences
Health Campus
Universiti Sains Malaysia
Kelantan
16150
Malaysia
| ORCID ID |
0000-0001-6907-8920 |
|---|---|
| Phone | +60 97677588 |
| intanidiana@usm.my |
Public
Renmin Road
Chenzhou
423000
China
| Phone | +86 17373529520 |
|---|---|
| 1435832421@qq.com |
Study information
| Study design | A randomized open-label controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | 42906 PIS.pdf |
| Scientific title | Effectiveness of a Mobile App–Based (OASapp) Intervention Among Older Adults Stroke Survivors |
| Study acronym | OASapp |
| Study hypothesis | The OASapp for older adults stroke survivors is effective in improving medication adherence, medicine belief, health literacy on stroke and reducing blood pressure |
| Ethics approval(s) | 1. Approved 24/06/2022, Ethical committees of the Affiliated Hospital of Xiangnan University (Renmin Road, Chenzhou, Hunan province, China; +86 7352325232; no email provided), ref: Linyan K2022—003—01 2. Approved 09/06/2022, Ethical committees of Chenzhou No. 1 People’s Hospital (Luojiajing Road, Chenzhou, Hunan province, China; +86 7352343039; no email provided), ref: Yu2022033 3. Approved 16/06/2022, Ethical committees of Chenzhou Third People’s People’s Hospital (Jiankang Road, Chenzhou, Hunan province, China; +86 7358889030; no email provided), ref: Lunshen 2022—10 |
| Condition | Prevention of cardiovascular disease in older adults stroke survivors |
| Intervention | Current interventions as of 09/05/2024: Consented patients will undergo randomization in a 1:1 ratio to the intervention group or control group. The random allocation sequence will be computer generated in blocks of four by an independent researcher who is not involved in data collection. The total sample size is 80 (40 × 2 arms). The study will last three months. For the intervention group, participants will be provided with a detailed explanation of the e-MAIMES in person by the project team leader and will be asked to utilize the app daily during a three-month period and receive one push notification each day at 19:00-21:00, with helpful self-care management tips. For the control group, they will not receive the app or any material included in the app during the study period. However, they will get access to the app after the 3-month trial. _____ Previous interventions: Consented patients will undergo randomization in a 1:1 ratio to the intervention group or control group. The random allocation sequence will be computer generated in blocks of four by an independent researcher who is not involved in data collection. The total sample size is 84 (42 × 2 arms). The study will last three months. For the intervention group, participants will be provided with a detailed explanation of the e-MAIMES in person by the project team leader and will be asked to utilize the app daily during a three-month period and receive one push notification each day at 19:00-21:00, with helpful self-care management tips. For the control group, they will not receive the app or any material included in the app during the study period. However, they will get access to the app after the 3-month trial. |
| Intervention type | Behavioural |
| Primary outcome measure | Current primary outcome measures as of 16/08/2023: Measured at baseline, 1 month and 3 months: 1. The general medication adherence scale (GMAS-C) 2. Blood pressure (mmHg) measured using a sphygmomanometer Previous primary outcome measures: Measured at baseline, 1 month and 3 months: 1. The general medication adherence scale (GMAS-C) 2. Beliefs about Medicines Questionnaire (BMQ) 3. Health literacy scale for stroke patients |
| Secondary outcome measures | Current secondary outcome measure as of 16/08/2023: Beliefs about medication and health literacy measured using the Beliefs about Medicines Questionnaire (BMQ) for stroke patients at baseline and 3 months Previous secondary outcome measure: Blood pressure (mmHg) is measured (sphygmomanometer) at baseline, 1 month and 3 months. |
| Overall study start date | 01/08/2021 |
| Overall study end date | 28/09/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 80 |
| Participant inclusion criteria | Current participant inclusion criteria as of 16/08/2023: 1. Aged 60 years or older 2. Have a history of stroke 3. Having a diagnosis of hypertension, either in the patient’s medical history or on admission to the hospital, defined as 140 mm Hg or higher for systolic blood pressure (SBP) and/or 90 mm Hg or higher for diastolic blood pressure by physicians 4. Taking at least one medication in the previous month such as (but not limited to) anti-platelets, statins, and anti-hypertensives to control risk factors for strokes 5. Having a smartphone and internet access to download App 6. More than a month since the last stroke episode 7. Modified Rankin Score of three or less 8. Able to read Chinese and communicate in Mandarin Chinese or the local Chenzhou dialect 9. Non-medication adherence (Patients with a total score of 26 according to the Chinese version of the General Medication Adherence Scale (GMAS-C)) Previous participant inclusion criteria: 1. Aged 60 years or older 2. Have a history of stroke 3. Having a diagnosis of hypertension, either in the patient’s medical history or on admission to the hospital, defined as 140 mm Hg or higher for systolic blood pressure (SBP) and/or 90 mm Hg or higher for diastolic blood pressure by physicians 4. Taking at least one medication in the previous month such as (but not limited to) anti-platelets, statins, and anti-hypertensives to control risk factors for strokes 5. Having a smartphone and internet access to download App 6. More than a month since the last stroke episode 7. Modified Rankin Score of three or less 8. Able to read Chinese and communicate in Mandarin Chinese or the local Chenzhou dialect |
| Participant exclusion criteria | 1. The persons who had diagnosed with cognitive impairment (Mini-Mental State Examination score ≤17 [for illiterate] or ≤20 [individuals with 1–6 years of education] or ≤24 [individuals with 7 or more years of education]) 2. Participating in another ongoing trial 3. Psychiatric illness or deafness, aphasia, or other language barriers 4. Secondary hypertension 5. Had participated in the Beta testing study |
| Recruitment start date | 20/01/2023 |
| Recruitment end date | 31/05/2023 |
Locations
Countries of recruitment
- China
Study participating centres
Chenzhou
423000
China
Chenzhou
423000
China
Chenzhou
423000
China
Sponsor information
University/education
Chenzhou Road, 889 hao
Chenzhou
423000
China
| Phone | +86 2653023 |
|---|---|
| xnygzx@163.com | |
| Website | https://www.xnu.edu.cn |
"ROR" |
https://ror.org/05by9mg64 |
University/education
School of Health Sciences
Health Campus
Universiti Sains Malaysia 16150
Kubang Kerian
Kelantan
16150
Malaysia
| Phone | +60 4-653 3888 |
|---|---|
| hello@usm.my | |
| Website | http://www.usm.my/ |
Funders
Funder type
Government
No information available
No information available
Results and Publications
| Intention to publish date | 12/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-review jounal |
| IPD sharing plan | The data will available on request and published as a supplement to the results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 19/12/2022 | No | Yes | ||
| Basic results | 21/10/2024 | No | No |
Additional files
Editorial Notes
21/10/2024: Basic results added.
09/05/2024: The following changes were made to the trial record:
1. The public title was changed from "Effectiveness of a mobile application intervention on medication adherence in older adults stroke survivors" to "Effectiveness of a Mobile App–Based (OASapp) Intervention Among Older Adults Stroke Survivors".
2. The scientific title was changed from "Effectiveness of a mobile application intervention module (e-MAIMES) for elderly stroke survivors in Chenzhou, China" to "Effectiveness of a Mobile App–Based (OASapp) Intervention Among Older Adults Stroke Survivors".
3. The acronym was changed from "e-MAIMES" to "OASapp".
4. The study hypothesis was changed from "The mobile application for elderly stroke survivors is effective in improving medication adherence, medicine belief, health literacy on stroke and reducing blood pressure" to "The OASapp for older adults stroke survivors is effective in improving medication adherence, medicine belief, health literacy on stroke and reducing blood pressure".
5. The overall end date was changed from 06/09/2023 to 28/09/2023.
6. The condition was changed from "Prevention of cardiovascular disease in elderly stroke survivors" to "Prevention of cardiovascular disease in older adults stroke survivors".
7. The interventions were changed.
8. The intention to publish date was changed from 12/12/2023 to 12/12/2024.
9. The plain English summary was updated to reflect these changes.
07/05/2024: The target number of participants was changed from 84 to 80.
16/08/2023: The following changes have been made and the plain English summary updated accordingly:
1. The overall study start date has been changed from 01/02/2022 to 01/08/2021.
2. The primary outcome measures were changed.
3. The secondary outcome measures were changed.
4. The participant inclusion criteria were changed.
5. The recruitment start date was changed from 01/02/2023 to 20/01/2023.
18/01/2023: The following changes have been made:
1. The recruitment start date has been changed from 03/03/2023 to 01/02/2023.
2. The recruitment end date has been changed from 25/04/2023 to 31/05/2023.
3. The public title has been changed from "Evaluation of a mobile application intervention for elderly stroke survivors in Chenzhou, China" to "Effectiveness of a mobile application intervention on medication adherence in older adults stroke survivors".
19/12/2022: Trial's existence confirmed by Ethical committees of the Affiliated Hospital of Xiangnan University.
