Diabetes Mellitus, Type 2SCOPE-DMNCT03890991
Self-Care for Older People With Diabetes Mellitus
A study testing SCOPE-DM, SCOPE-DM with 3 months' supply of glucometer and SCOPE-DM with 6 months' supply of glucometer in people with Diabetes Mellitus, Type 2, run by National University of Singapore at 1 site in Singapore.
Trial summary
In Singapore, the prevalence of diabetes was approximately 12.8% in 2014 and was projected to rise to 22.7% in 2035. In 2015, the International Diabetes Federation (IDF) reported that Singapore has the second highest proportion of diabetic patients among developed nations. Read more about this study
- Who is it for?
- Ages 55 to 99 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- SCOPE-DM, SCOPE-DM with 3 months' supply of glucometer and SCOPE-DM with 6 months' supply of glucometer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteSingapore
- Study dates
- 26 Feb 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with type 2 diabetes mellitus
- Aged 55 to 99 years old (both inclusive)
- Community-dwelling
Who cannot join
- Individuals with Type 1 diabetes mellitus
- Unable to communicate independently in English or Mandarin
- Mentally incapacitated individuals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-Care for Older People With Diabetes Mellitus (SCOPE-DM): Live Well With Diabetes Programme
In Singapore, the prevalence of diabetes was approximately 12.8% in 2014 and was projected to rise to 22.7% in 2035. In 2015, the International Diabetes Federation (IDF) reported that Singapore has the second highest proportion of diabetic patients among developed nations. The impact of poorly controlled diabetes on the individual, family and health system is well known. Previous studies have shown that older persons, specifically those with chronic conditions such as diabetes, often lack sufficient knowledge about their condition and thus frequently have poor self-management skills, which is essential for good health outcome.
Health education among older persons, particularly those with chronic illnesses, has long been promoted as a priority. Chodosh and colleagues (2005) determined that there were benefits and significant improvement in blood glucose and blood pressure for chronic disease self-management programs for older adults with diabetes and high blood pressure respectively in a meta-analysis study. This project [Self-Care for Older People with Diabetes Mellitus (SCOPE-DM)] was therefore developed to help community-dwelling older patients with type 2 diabetes to effectively manage their disease by reducing diabetes-related risk factors and complications, leading to an improvement in their psychological well-being and health-related quality of life, as well as a reduction in future healthcare requirements from family and society. This study aims to investigate the effectiveness of the SCOPE-DM programme in improving the self-efficacy, motivation, medication adherence, health-related quality of life and diabetes knowledge among community-dwelling older adults with type 2 diabetes in Singapore.
This proposed study is a prospective, four-group cluster randomized controlled trial. The participants will be followed up for 6 months at the community sites and Hua Mei Clinics of the Tsao Foundation. A set of questionnaires will be used to assess participants' self-efficacy, diabetic self-care activities, health-related quality of life (HRQoL), diabetes knowledge and medication adherence. Process evaluation will also be conducted to assess the acceptability, strengths and weaknesses of the 'SCOPE-DM: Live Well with Diabetes' programme based on the participants' perspectives through the conduct of qualitative interviews.
Read the detailed description
Overview
This study is a prospective, four-group cluster randomized controlled trial. The participants will be followed up for 6 months at the community sites or Hua Mei Clinics of the Tsao Foundation.
The 4 groups are:
- Control group receiving routine care from their healthcare provider/ clinics of Tsao Foundation ii. Intervention group 1 receiving the SCOPE-DM programme without supply of glucometers and accessories iii. Intervention group 2 receiving the SCOPE-DM programme as well as 3 months' supply of glucometers and accessories iv. Intervention group 3 receiving the SCOPE-DM programme as well as 6 months' supply of glucometers and accessories
A staff of Tsao Foundation will recruit community-dwelling adults with diabetes from the 68 community sites around Singapore. After which, the research associate (RA) or Fellow appointed to represent the Site Principal Investigator will screen the individuals participating for eligibility to join this research study. Alternatively, potential participants will be referred to the RA or Fellow to be screened for eligibility. Eligible individuals will be invited to participate in the research study, of which interested individuals will be explained with the study procedure and informed consent will be taken by the RA.
Inclusion Criteria:
- Individuals with type 2 diabetes mellitus
- Aged 55 to 99 years old (both inclusive)
- Community-dwelling
Exclusion Criteria:
- Individuals with Type 1 diabetes mellitus
- Unable to communicate independently in English or Mandarin
- Mentally incapacitated individuals
The 68 sites will form the cluster sites for the study and will be assigned to any one of the 4 groups via a randomisation process (control, intervention group 1, 2 and 3). The randomisation process will be generated by the research team before recruitment begins using a computerised programme. Each group will thus consist of 17 sites. All the participants belonging to each group of 17 sites will be invited to participate in the study if they meet the inclusion criteria until we have reached the target number of 80 for each group.
Questionnaire administration
Questionnaires to elucidate the humanistic outcomes will be administered at baseline, 3 and 6 months from baseline respectively for all 4 groups. Each questionnaire administration will last for around 45 minutes.
The questionnaire will be used to assess participants' self-efficacy, diabetic self-care activities, health-related quality of life (HRQoL), diabetes knowledge and medication adherence. Participant demographics, anthropometric parameters, past medical history, and current medication use will be collected. A staff from Tsao Foundation will provide the clinical data and laboratory test results (HbA1c, blood pressure, TChol, LDL-C, HDL-C, TG, BMI and adherence to yearly eye and foot screenings) to the RA or Fellow of the project. Consent will be obtained from the participants before Tsao Foundation releases the clinical data and laboratory test results to the research team. The data and test results will be printed out by the staff of Tsao Foundation and handed over to the RA or Fellow in an opaque sealed envelope. Only the RA or Fellow, Co-Investigators and Principal Investigators of the study are authorised to open the sealed envelope and retrieve data. A representative of Tsao Foundation may call the subject for care- and administrative-related matters if needed such as reminding the participants to attend the SCOPE-DM programme or to follow up on the questionnaire administration.
Process Evaluation
The purpose of the process evaluation is to assess the acceptability, strengths and weaknesses of the 'SCOPE-DM: Live Well with Diabetes' programme based on the participants' perspectives. A qualitative approach using individual face-to-face audio-recorded interviews will be adopted. The RA will conduct these interviews after the completion of the study intervention and upon the participant's consent. A purposive sample of 30 participants will be recruited from intervention groups to participate in the interviews to share their experiences while in the programme as well as obtain their opinions and suggestions to improve the programme.
All interviews will be audio-recorded. An interview guide will be developed based on the overall aim of the SCOPE-DM program. The participants will be reminded not to reveal any information that may identify themselves before the interview commences as interviews will be audio-recorded. The qualitative interview will last for about 1 hour.
The administration of the questionnaires and conduct of the interviews will be done at a room with privacy and confidentiality maintained at the Hua Mei Clinics or any of the community sites. The venue to administer the questionnaires and interviews are appropriately equipped with tables, chairs and rooms to ensure the privacy and confidentiality of participants.
Details of SCOPE-DM intervention programme
Tsao Foundation's trained diabetes nurse educators will commence the SCOPE-DM intervention programme once 8 to 10 participants agreed to participate. Tsao Foundation will be responsible for training 20 diabetes nurse educators to deliver the programme. The SCOPE-DM programme will be conducted at Hua Mei Clinics or any of the community sites. Each session will last around 2 hours.
The programme aims to support motivation and enable capability for managing diabetes. To this end, the session will integrate the knowledge and practical skills components offered in traditional diabetes education with psychological techniques and principles for behavioural change: problem solving, goal-setting and monitoring. The programme offers the potential for older people to learn about their condition and treatment in a psychologically-motivating and confidence-enhancing structure - as such the emphasis is on empowering individuals to make choices and lifestyle changes in line with treatment recommendations through the use of problem solving, goal setting and feedback, and not just on knowledge transfer which has not been shown to be successful in behavioural change. The content and delivery format will largely be informed by motivational interviewing (MI).
Motivational interviewing is a well-recognized person-centered counselling approach aiming at eliciting and strengthening motivation to change. It is designed to guide towards a specific goal by eliciting and exploring the person's own reasons for change, goals and values within an atmosphere of acceptance and empathy.There is now a wealth of evidence from randomized trials for the effectiveness of MI in health behavioural change.To facilitate engagement and rapport with the participants, MI will be blended with guided autobiography as means to share life experiences and meaning and hence allowing for better alignment of health behavioural changes with participants' personal goals and values.
The 2-hour weekly sessions will apply the strategies of group-based activities, problem solving, motivational building and goal setting, vicarious experience, enactive attainment and physiological feedback. Themes will include dealing with the medical management of the disease (medical management); maintaining, changing, and creating new meaningful behaviours or life roles (role management), and dealing with the emotional consequences of having a chronic condition (emotional management).
These topics are taught by means of skills mastery through goal setting and feedback on progress, modelling of self-management behaviours and problem-solving strategies, and social persuasion through group support and guidance for individual self-management efforts.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- SCOPE-DM, SCOPE-DM with 3 months' supply of glucometer, SCOPE-DM with 6 months' supply of glucometer
- Keywords
- Intervention, Self-efficacy, Diabetes Self-care Activities, Self-Monitoring of Blood Glucose, Diabetes, Community, Older people with diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCOPE-DMBehavioural
The 12-week programme aims to support motivation and enable capability for managing diabetes. To this end, the sessions will integrate the knowledge and practical skills components offered in traditional diabetes education with psychological techniques and principles for behavioural change: problem solving, goal-setting and monitoring. The programme offers the potential for older people to learn about their condition and treatment in a psychologically-motivating and confidence-enhancing structure - as such the emphasis is on empowering individuals to make choices and lifestyle changes in line with treatment recommendations through the use of problem solving, goal setting and feedback, and not just on knowledge transfer which has not been shown to be successful in behavioural change. The content and delivery format will largely be informed by motivational interviewing
SCOPE-DM with 3 months' supply of glucometerBehavioural
Participants in this arm will participate in the SCOPE-DM programme and use the glucometer for 3 months.
SCOPE-DM with 6 months' supply of glucometerBehavioural
Participants in this arm will participate the in SCOPE-DM programme and use the glucometer for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| SCOPE-DM only | Experimental | Participation in SCOPE-DM programme without supply of glucometers and accessories Receives: Behavioral: SCOPE-DM |
| SCOPE-DM with 3 months' supply of glucometer | Active comparator | Participation in SCOPE-DM programme with 3 months' supply of glucometers and accessories Receives: Behavioral: SCOPE-DM with 3 months' supply of glucometer |
| SCOPE-DM with 6 months' supply of glucometer | Active comparator | Participation in SCOPE-DM programme with 6 months' supply of glucometers and accessories. Receives: Behavioral: SCOPE-DM with 6 months' supply of glucometer |
| Control | No intervention | Usual care by healthcare provider/ clinics of Tsao Foundation without participation in SCOPE-DM programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy assessed using the General Self-efficacy Scale
Participants' level of self-efficacy is assessed using the ten-item General Self-efficacy Scale. Participants indicate their responses on a Likert scale of 1 ("Not at all true") to 4 ("Exactly true"). Scores for the ten items are then summed, with higher summed scores indicating higher levels of self-efficacy. The minimum possible summed score is 10 and the maximum possible summed score is 40. Participants in the three intervention conditions are hypothesized to have statistically significantly higher summed scores post-intervention, compared to control condition participants.
Measured: 6 months
Diabetes self-care activities measured using the Revised Summary of Diabetes Self-care Activities
Diabetes self-care activities are assessed using a 13-item scale. Participants indicate their responses to items 1 to 12 on a scale of 0 to 7 corresponding to the number of days within the past seven days that they have performed the activities indicated. For item 13, participants indicate whether they have smoked within the past seven days, and if so, how many cigarettes on an average day. For each regimen area of general diet, exercise, blood sugar testing, footcare, and medications, the responses of the corresponding items are averaged to indicate the mean number of days, with a higher value indicating a higher level of self-care activity for the regimen area. A score of 0 is assigned to non-smoking and a score of 1 assigned to smoking, with higher scores indicating lower self-care. Participants in the three intervention conditions are hypothesized to have a statistically significantly higher level of self-care activities post-intervention, compared to control participants.
Measured: 6 months
Secondary outcomes (8)
Diabetes-specific quality of life measured using the Audit of Diabetes-Dependent Quality of Life
The first two items ask participants about current quality of life (rated on a 7-point Likert Scale ranging from -3 to +3) and diabetes-dependent quality of life (rated on a 5-point Likert scale ranging from -3 to +1. Lower scores indicate a lower quality of life. The subsequent 19 items assess the impact of diabetes on 19 life domains. For each life domain, participants indicate the level of impact on a 5-point Likert scale ranging from -3 ("greatest") to +1 ("least"), and the importance of the domain to them on a 4-point Likert scale ranging from 3 ("very important") to 0 ("Not at all important"). The two ratings for each item are then multiplied before the products are averaged across all applicable domains for an average weighted impact score ranging from -9 to 3. Scores equal to or above the lower quartile score indicate a higher quality of life. The outcome measure will be the proportion of participants in each condition with scores equal or above the lower quartile score.
Measured: 6 months
Participants' level of knowledge of Diabetes assessed using the Revised Michigan Diabetes Knowledge Questionnaire
Participants' level of knowledge of Diabetes is assessed using the 20-item Revised Michigan Diabetes Knowledge Questionnaire (Diabetes Knowledge Test). Participants indicate their responses from the options of "True", "False" or "Don't know". A higher proportion of correct responses on this scale is indicative of a higher level of knowledge regarding Diabetes. Participants in the three intervention conditions are hypothesized to have statistically significantly higher levels of knowledge regarding Diabetes post-intervention, compared to control condition participants.
Measured: 6 months
Participants' level of medication adherence assessed using Medication Adherence Report Scale
Level of medication adherence is assessed using the five-item Medication Adherence Report Scale. Participants indicate their responses on a five-point Likert scale ranging from 1 ("Always") to 5 ("Never"). Higher scores are indicative of higher levels of medication adherence, with a minimum possible summed score of 5 and a maximum possible summed score of 25. The target score is 25 indicating perfect adherence to medication, and the outcome measure would be the proportion of participants in each study condition with a summed score of 25.
Measured: 6 months
Proportion of participants with optimal Glycated haemoglobin Level (HbA1c Level) of 7% or lower
Glycated haemoglobin level is an indication of an individual's average blood glucose level over the past three months. For individuals with type 2 diabetes, in general, the optimal HbA1c level should be 7% or lower. Thus, the outcome measured would be the proportion of participants from each study condition with Glycated haemoglobin level of 7% or lower.
Measured: 6 months
Proportion of participants with optimal Systolic and Diastolic Blood Pressure
The optimal Systolic and Diastolic Blood Pressure would be below 140 over 80mmHg. Thus, the outcome measured would be the proportion of participants from each study condition with Systolic and Diastolic Blood Pressure below 140 over 80mmHg.
Measured: 6 months
Proportion of participants with optimal levels of Total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglyceride
The outcome measured would be the proportion of participants from each study condition with the optimal levels of Total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglyceride. Optimal level for total cholesterol should be less than 5.2mmol/L, optimal high-density lipoprotein cholesterol level should be more than 1.5mmol/L, optimal low-density lipoprotein cholesterol level should be less than 2.6 mmol/L and optimal triglyceride level should be less than 1.7mmol/L.
Measured: 6 months
Proportion of participants with optimal Body Mass Index between 18.5 and 22.9
The outcome measured would be the proportion of participants from each study condition with optimal Body Mass Index between 18.5 and 22.9 (both inclusive).
Measured: 6 months
Proportion of participants who adhere to yearly eye and foot screening
The outcome measured would be the proportion of participants from each study condition with self-reported adherence to yearly eye screening and foot screening. Yearly eye screening and foot screening are assessed through two of the items in the questionnaire asking participants if they have gone for yearly eye screening and foot screening respectively. For both items, response options are "Yes" or "No". Participants who answer "Yes" to both questions would be regarded as having adhered to yearly eye and foot screening.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start26 Feb 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Tsao Foundation Singapore
- Responsible party
- Principal investigator, Raymond Boon Tar Lim, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890991
- Sponsor's protocol ID
- H-18-074
- Acronym
- SCOPE-DM
- Status last verified
- Sep 2022
- First submitted
- 14 Mar 2019
- Last updated
- 28 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Care for Older People With Diabetes Mellitus (SCOPE-DM): Live Well With Diabetes Programme
- ClinicalTrials.gov ID
- NCT03890991
- Acronym / sponsor ID
- SCOPE-DM / H-18-074
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Intervention, Self-efficacy, Diabetes Self-care Activities, Self-Monitoring of Blood Glucose, Diabetes, Community, Older people with diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Tsao Foundation Singapore
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In Singapore, the prevalence of diabetes was approximately 12.8% in 2014 and was projected to rise to 22.7% in 2035. In 2015, the International Diabetes Federation (IDF) reported that Singapore has the second highest proportion of diabetic patients among developed nations. The impact of poorly controlled diabetes on the individual, family and health system is well known. Previous studies have shown that older persons, specifically those with chronic conditions such as diabetes, often lack sufficient knowledge about their condition and thus frequently have poor self-management skills, which is essential for good health outcome.
Health education among older persons, particularly those with chronic illnesses, has long been promoted as a priority. Chodosh and colleagues (2005) determined that there were benefits and significant improvement in blood glucose and blood pressure for chronic disease self-management programs for older adults with diabetes and high blood pressure respectively in a meta-analysis study. This project [Self-Care for Older People with Diabetes Mellitus (SCOPE-DM)] was therefore developed to help community-dwelling older patients with type 2 diabetes to effectively manage their disease by reducing diabetes-related risk factors and complications, leading to an improvement in their psychological well-being and health-related quality of life, as well as a reduction in future healthcare requirements from family and society. This study aims to investigate the effectiveness of the SCOPE-DM programme in improving the self-efficacy, motivation, medication adherence, health-related quality of life and diabetes knowledge among community-dwelling older adults with type 2 diabetes in Singapore.
This proposed study is a prospective, four-group cluster randomized controlled trial. The participants will be followed up for 6 months at the community sites and Hua Mei Clinics of the Tsao Foundation. A set of questionnaires will be used to assess participants' self-efficacy, diabetic self-care activities, health-related quality of life (HRQoL), diabetes knowledge and medication adherence. Process evaluation will also be conducted to assess the acceptability, strengths and weaknesses of the 'SCOPE-DM: Live Well with Diabetes' programme based on the participants' perspectives through the conduct of qualitative interviews.
Detailed description
Overview
This study is a prospective, four-group cluster randomized controlled trial. The participants will be followed up for 6 months at the community sites or Hua Mei Clinics of the Tsao Foundation.
The 4 groups are:
- Control group receiving routine care from their healthcare provider/ clinics of Tsao Foundation ii. Intervention group 1 receiving the SCOPE-DM programme without supply of glucometers and accessories iii. Intervention group 2 receiving the SCOPE-DM programme as well as 3 months' supply of glucometers and accessories iv. Intervention group 3 receiving the SCOPE-DM programme as well as 6 months' supply of glucometers and accessories
A staff of Tsao Foundation will recruit community-dwelling adults with diabetes from the 68 community sites around Singapore. After which, the research associate (RA) or Fellow appointed to represent the Site Principal Investigator will screen the individuals participating for eligibility to join this research study. Alternatively, potential participants will be referred to the RA or Fellow to be screened for eligibility. Eligible individuals will be invited to participate in the research study, of which interested individuals will be explained with the study procedure and informed consent will be taken by the RA.
Inclusion Criteria:
- Individuals with type 2 diabetes mellitus
- Aged 55 to 99 years old (both inclusive)
- Community-dwelling
Exclusion Criteria:
- Individuals with Type 1 diabetes mellitus
- Unable to communicate independently in English or Mandarin
- Mentally incapacitated individuals
The 68 sites will form the cluster sites for the study and will be assigned to any one of the 4 groups via a randomisation process (control, intervention group 1, 2 and 3). The randomisation process will be generated by the research team before recruitment begins using a computerised programme. Each group will thus consist of 17 sites. All the participants belonging to each group of 17 sites will be invited to participate in the study if they meet the inclusion criteria until we have reached the target number of 80 for each group.
Questionnaire administration
Questionnaires to elucidate the humanistic outcomes will be administered at baseline, 3 and 6 months from baseline respectively for all 4 groups. Each questionnaire administration will last for around 45 minutes.
The questionnaire will be used to assess participants' self-efficacy, diabetic self-care activities, health-related quality of life (HRQoL), diabetes knowledge and medication adherence. Participant demographics, anthropometric parameters, past medical history, and current medication use will be collected. A staff from Tsao Foundation will provide the clinical data and laboratory test results (HbA1c, blood pressure, TChol, LDL-C, HDL-C, TG, BMI and adherence to yearly eye and foot screenings) to the RA or Fellow of the project. Consent will be obtained from the participants before Tsao Foundation releases the clinical data and laboratory test results to the research team. The data and test results will be printed out by the staff of Tsao Foundation and handed over to the RA or Fellow in an opaque sealed envelope. Only the RA or Fellow, Co-Investigators and Principal Investigators of the study are authorised to open the sealed envelope and retrieve data. A representative of Tsao Foundation may call the subject for care- and administrative-related matters if needed such as reminding the participants to attend the SCOPE-DM programme or to follow up on the questionnaire administration.
Process Evaluation
The purpose of the process evaluation is to assess the acceptability, strengths and weaknesses of the 'SCOPE-DM: Live Well with Diabetes' programme based on the participants' perspectives. A qualitative approach using individual face-to-face audio-recorded interviews will be adopted. The RA will conduct these interviews after the completion of the study intervention and upon the participant's consent. A purposive sample of 30 participants will be recruited from intervention groups to participate in the interviews to share their experiences while in the programme as well as obtain their opinions and suggestions to improve the programme.
All interviews will be audio-recorded. An interview guide will be developed based on the overall aim of the SCOPE-DM program. The participants will be reminded not to reveal any information that may identify themselves before the interview commences as interviews will be audio-recorded. The qualitative interview will last for about 1 hour.
The administration of the questionnaires and conduct of the interviews will be done at a room with privacy and confidentiality maintained at the Hua Mei Clinics or any of the community sites. The venue to administer the questionnaires and interviews are appropriately equipped with tables, chairs and rooms to ensure the privacy and confidentiality of participants.
Details of SCOPE-DM intervention programme
Tsao Foundation's trained diabetes nurse educators will commence the SCOPE-DM intervention programme once 8 to 10 participants agreed to participate. Tsao Foundation will be responsible for training 20 diabetes nurse educators to deliver the programme. The SCOPE-DM programme will be conducted at Hua Mei Clinics or any of the community sites. Each session will last around 2 hours.
The programme aims to support motivation and enable capability for managing diabetes. To this end, the session will integrate the knowledge and practical skills components offered in traditional diabetes education with psychological techniques and principles for behavioural change: problem solving, goal-setting and monitoring. The programme offers the potential for older people to learn about their condition and treatment in a psychologically-motivating and confidence-enhancing structure - as such the emphasis is on empowering individuals to make choices and lifestyle changes in line with treatment recommendations through the use of problem solving, goal setting and feedback, and not just on knowledge transfer which has not been shown to be successful in behavioural change. The content and delivery format will largely be informed by motivational interviewing (MI).
Motivational interviewing is a well-recognized person-centered counselling approach aiming at eliciting and strengthening motivation to change. It is designed to guide towards a specific goal by eliciting and exploring the person's own reasons for change, goals and values within an atmosphere of acceptance and empathy.There is now a wealth of evidence from randomized trials for the effectiveness of MI in health behavioural change.To facilitate engagement and rapport with the participants, MI will be blended with guided autobiography as means to share life experiences and meaning and hence allowing for better alignment of health behavioural changes with participants' personal goals and values.
The 2-hour weekly sessions will apply the strategies of group-based activities, problem solving, motivational building and goal setting, vicarious experience, enactive attainment and physiological feedback. Themes will include dealing with the medical management of the disease (medical management); maintaining, changing, and creating new meaningful behaviours or life roles (role management), and dealing with the emotional consequences of having a chronic condition (emotional management).
These topics are taught by means of skills mastery through goal setting and feedback on progress, modelling of self-management behaviours and problem-solving strategies, and social persuasion through group support and guidance for individual self-management efforts.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SCOPE-DM only | Experimental | Behavioral: SCOPE-DMParticipation in SCOPE-DM programme without supply of glucometers and accessories |
| SCOPE-DM with 3 months' supply of glucometer | Active comparator | Behavioral: SCOPE-DM with 3 months' supply of glucometerParticipation in SCOPE-DM programme with 3 months' supply of glucometers and accessories |
| SCOPE-DM with 6 months' supply of glucometer | Active comparator | Behavioral: SCOPE-DM with 6 months' supply of glucometerParticipation in SCOPE-DM programme with 6 months' supply of glucometers and accessories. |
| Control | No intervention | –Usual care by healthcare provider/ clinics of Tsao Foundation without participation in SCOPE-DM programme |
Who may qualify
- Ages
- 55 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals with type 2 diabetes mellitus
- Aged 55 to 99 years old (both inclusive)
- Community-dwelling
Key exclusion criteria (3 listed)
- Individuals with Type 1 diabetes mellitus
- Unable to communicate independently in English or Mandarin
- Mentally incapacitated individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCOPE-DMThe 12-week programme aims to support motivation and enable capability for managing diabetes. To this end, the sessions will integrate the knowledge and practical skills components offered in traditional diabetes education with psychological techniques and principles for behavioural change: problem solving, goal-setting and monitoring. The programme offers the potential for older people to learn about their condition and treatment in a psychologically-motivating and confidence-enhancing structure - as such the emphasis is on empowering individuals to make choices and lifestyle changes in line with treatment recommendations through the use of problem solving, goal setting and feedback, and not just on knowledge transfer which has not been shown to be successful in behavioural change. The content and delivery format will largely be informed by motivational interviewing | Behavioural | SCOPE-DM only |
| SCOPE-DM with 3 months' supply of glucometerParticipants in this arm will participate in the SCOPE-DM programme and use the glucometer for 3 months. | Behavioural | SCOPE-DM with 3 months' supply of glucometer |
| SCOPE-DM with 6 months' supply of glucometerParticipants in this arm will participate the in SCOPE-DM programme and use the glucometer for 6 months. | Behavioural | SCOPE-DM with 6 months' supply of glucometer |
Primary outcome
Self-efficacy assessed using the General Self-efficacy Scale
Time frame: 6 months
Participants' level of self-efficacy is assessed using the ten-item General Self-efficacy Scale. Participants indicate their responses on a Likert scale of 1 ("Not at all true") to 4 ("Exactly true"). Scores for the ten items are then summed, with higher summed scores indicating higher levels of self-efficacy. The minimum possible summed score is 10 and the maximum possible summed score is 40. Participants in the three intervention conditions are hypothesized to have statistically significantly higher summed scores post-intervention, compared to control condition participants.
Diabetes self-care activities measured using the Revised Summary of Diabetes Self-care Activities
Time frame: 6 months
Diabetes self-care activities are assessed using a 13-item scale. Participants indicate their responses to items 1 to 12 on a scale of 0 to 7 corresponding to the number of days within the past seven days that they have performed the activities indicated. For item 13, participants indicate whether they have smoked within the past seven days, and if so, how many cigarettes on an average day. For each regimen area of general diet, exercise, blood sugar testing, footcare, and medications, the responses of the corresponding items are averaged to indicate the mean number of days, with a higher value indicating a higher level of self-care activity for the regimen area. A score of 0 is assigned to non-smoking and a score of 1 assigned to smoking, with higher scores indicating lower self-care. Participants in the three intervention conditions are hypothesized to have a statistically significantly higher level of self-care activities post-intervention, compared to control participants.
8 secondary outcomes
Diabetes-specific quality of life measured using the Audit of Diabetes-Dependent Quality of Life
Time frame: 6 months
Participants' level of knowledge of Diabetes assessed using the Revised Michigan Diabetes Knowledge Questionnaire
Time frame: 6 months
Participants' level of medication adherence assessed using Medication Adherence Report Scale
Time frame: 6 months
Proportion of participants with optimal Glycated haemoglobin Level (HbA1c Level) of 7% or lower
Time frame: 6 months
Proportion of participants with optimal Systolic and Diastolic Blood Pressure
Time frame: 6 months
Proportion of participants with optimal levels of Total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglyceride
Time frame: 6 months
Proportion of participants with optimal Body Mass Index between 18.5 and 22.9
Time frame: 6 months
Proportion of participants who adhere to yearly eye and foot screening
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCOPE-DM, SCOPE-DM with 3 months' supply of glucometer and SCOPE-DM with 6 months' supply of glucometer in people with Diabetes Mellitus, Type 2, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-efficacy assessed using the General Self-efficacy Scale (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.