Educational interventions to improve self-care and reduce self-neglect in Iranian elderly people with diabetes
| ISRCTN | ISRCTN77260130 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77260130 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 19030 |
| Sponsor | Shiraz University of Medical Sciences |
| Funder | Shiraz University of Medical Sciences |
- Submission date
- 24/09/2021
- Registration date
- 28/09/2021
- Last edited
- 17/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Due to the increase in life expectancy, management of diabetes is very important and older diabetics should be able to take care of themselves to prevent or delay the complications of diabetes. The self-care deficit in elderly people with diabetes is due to an irreversible decrease in physical and cognitive function, and elderly people with diabetes have more cognitive problems than healthy individuals due to defects in memory and executive function. Mindfulness interventions can help change erroneous thoughts and behaviour patterns and a self-regulatory approach can empower the elderly in a step-by-step manner. The impact of mindfulness interventions or self-regulatory interventions has been examined separately but the effect of a combination of mindful self-care and self-regulation interventions has not been examined until now. The aim of this study is to compare the effect of self-regulatory intervention programs only with a combination of mindful self-care and self-regulation interventions on self-care, self-regulation, mindful self-care, and self-neglect in elderly people with diabetes.
Who can participate?
Community-dwelling elderly people aged 60-80 years with diabetes
What does the study involve?
First, participants are selected from three centers that are randomly selected by simple random sampling. Each center is assigned to one intervention group and the number of participants in each center is 45. Seniors fill out five questionnaires, and then the daily training starts via WhatsApp and lasts for 2 months. After 4 weeks testing is performed and after 16 weeks a follow-up is performed.
What are the possible benefits and risks of participating?
Interventions improve self-care in the elderly and are not harmful.
Where is the study run from?
Shiraz University of Medical Sciences (Iran)
When is the study starting and how long is it expected to run for?
February 2020 to July 2021
Who is funding the study?
Shiraz University of Medical Sciences (Iran)
Who is the main contact?
1. Dr Mohammad Hossein Kaveh, mhkaveh255@gmail.com
2. Mohadeseh Motamed-Jahromi, mohadesehmotamed@gmail.com
Contact information
Scientific
School of Health, Department of Health Promotion
Shiraz
7153675541
Iran
 ORCID ID |
0000-0002-9141-3243 |
|---|---|
| Phone | +98 (0)7137256007 |
| Kaveh@sums.ac.ir |
Scientific
School of Health, Department of Health Promotion
Shiraz
7153675541
Iran
| ORCID ID |
0000-0001-6025-4879 |
|---|---|
| Phone | +98 (0)7137256007 |
| mohadesehmotamed@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Three-arm cluster randomized controlled trial |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | Designing and evaluating educational interventions based on mindfulness and/or self-regulation in improving self-neglect and self-care in elderly people with diabetes in Shiraz |
| Study objectives | Do educational interventions based on mindfulness or self-regulation affect the improvement of self-neglect and self-care of the elderly with diabetes in Shiraz, Iran? |
| Ethics approval(s) | Approved 26/02/2020, Shiraz University of Medical Sciences Research Ethics Committee (Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran; +98 (0)21 81455618; ethics@behdasht.gov.ir), ref: IR.SUMS.REC.1398.1365 |
| Health condition(s) or problem(s) studied | Community-dwelling elderly people with diabetes |
| Intervention | This study was conducted over 24 weeks at three Urban Health Centers in Shiraz, Iran. Among the urban health centers with the most people with diabetes, three centers were randomly selected and then the centers were randomly assigned to the intervention and control groups. The elderly who were eligible were identified and 45 people in each center were selected using a list of random numbers. Due to the prevalence of COVID-19, the training was done through WhatsApp software. Three WhatsApp groups were formed to provide training to the participants. In all three groups, training content was sent daily to participants for the first 2 months, and for the next 4 months training continued only on Mondays. Messages were sent in the form of text, images, media, audio, images, emoticons, and links. Data were collected between December 2020 and May 2021. In the first arm, a self-care training program focused on behavior change based on self-regulatory theory was sent. In the second arm, a combined intervention was presented that included mindful self-care training and a self-care training program based on self-regulatory theory. In the control arm (CO), COVID-19 prevention training was sent to the participants. Five questionnaires including demographic information, summary of diabetes self-care activities (SDSCA), the mindful self-care questionnaire (MSCS), Elder Self-Neglect Scale (ESNS), and Short form Self-Regulation Questionnaire (SSRQ) were used. Information from telephone interviews was collected at baseline, week 4, and week 16 after the intervention programs. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Measured at baseline, week 4, and week 16 after intervention programs: |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 30/07/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 135 |
| Key inclusion criteria | 1. Age 60-80 years old 2. Type 2 diabetes (duration ≥6 months) 3. Sufficient ability to read and write 4. Sufficient activity daily living 5. Sufficient WhatsApp and Internet literacy 6. Smartphone and Internet access |
| Key exclusion criteria | 1. Persistent serious psychological problem 2. Does not answer phone calls and messages more than three times 3. Reluctant to participate in the intervention |
| Date of first enrolment | 15/11/2020 |
| Date of final enrolment | 15/07/2021 |
Locations
Countries of recruitment
- Iran
Study participating centres
Shiraz
71 9100 2030
Iran
Shiraz
71 3824 5884
Iran
Shiraz
71 3821 9638
Iran
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | SPSS datasets without participants' names will send to academic readers after publishing the relevant articles if requested from Mohadeseh Motamed-Jahromi (mohadesehmotamed@gmail.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 15/06/2024 | 17/06/2024 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/06/2024: Publication reference added.
24/09/2021: Trial's existence confirmed by Shiraz University of Medical Sciences Research Ethics Committee.
