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Self-Care for Older People With Diabetes Mellitus (SCOPE-DM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890991
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : September 9, 2020
Sponsor:
Collaborator:
Tsao Foundation Singapore
Information provided by (Responsible Party):
Raymond Boon Tar Lim, National University, Singapore

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: SCOPE-DM Behavioral: SCOPE-DM with 3 months' supply of glucometer Behavioral: SCOPE-DM with 6 months' supply of glucometer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Self-Care for Older People With Diabetes Mellitus (SCOPE-DM): Live Well With Diabetes Programme
Actual Study Start Date : February 26, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: SCOPE-DM only
Participation in SCOPE-DM programme without supply of glucometers and accessories
Behavioral: SCOPE-DM
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

Active Comparator: SCOPE-DM with 3 months' supply of glucometer
Participation in SCOPE-DM programme with 3 months' supply of glucometers and accessories
Behavioral: SCOPE-DM with 3 months' supply of glucometer
Participants in this arm will participate in the SCOPE-DM programme and use the glucometer for 3 months.

Active Comparator: SCOPE-DM with 6 months' supply of glucometer
Participation in SCOPE-DM programme with 6 months' supply of glucometers and accessories.
Behavioral: SCOPE-DM with 6 months' supply of glucometer
Participants in this arm will participate the in SCOPE-DM programme and use the glucometer for 6 months.

No Intervention: Control
Usual care by healthcare provider/ clinics of Tsao Foundation without participation in SCOPE-DM programme



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Diabetes-specific quality of life measured using the Audit of Diabetes-Dependent Quality of Life [ Time Frame: 6 months ]
    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.

  2. Participants' level of knowledge of Diabetes assessed using the Revised Michigan Diabetes Knowledge Questionnaire [ Time Frame: 6 months ]
    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.

  3. Participants' level of medication adherence assessed using Medication Adherence Report Scale [ Time Frame: 6 months ]
    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.

  4. Proportion of participants with optimal Glycated haemoglobin Level (HbA1c Level) of 7% or lower [ Time Frame: 6 months ]
    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.

  5. Proportion of participants with optimal Systolic and Diastolic Blood Pressure [ Time Frame: 6 months ]
    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.

  6. Proportion of participants with optimal levels of Total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglyceride [ Time Frame: 6 months ]
    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.

  7. Proportion of participants with optimal Body Mass Index between 18.5 and 22.9 [ Time Frame: 6 months ]
    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).

  8. Proportion of participants who adhere to yearly eye and foot screening [ Time Frame: 6 months ]
    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.



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Ages Eligible for Study:   55 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890991


Contacts
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Contact: Raymond Boon Tar Lim, PhD (65) 6601 5425 ephlbtr@nus.edu.sg

Locations
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Singapore
Whampoa Community Club Recruiting
Singapore, Singapore
Contact: Raymond Boon Tar Lim, PhD         
Sponsors and Collaborators
National University, Singapore
Tsao Foundation Singapore
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Responsible Party: Raymond Boon Tar Lim, Lecturer, National University, Singapore
ClinicalTrials.gov Identifier: NCT03890991    
Other Study ID Numbers: H-18-074
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Raymond Boon Tar Lim, National University, Singapore:
Intervention
Self-efficacy
Diabetes Self-care Activities
Self-Monitoring of Blood Glucose
Diabetes
Community
Older people with diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases