Self-Care for Older People With Diabetes Mellitus (SCOPE-DM)
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|ClinicalTrials.gov Identifier: NCT03890991|
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : September 9, 2020
|First Submitted Date ICMJE||March 14, 2019|
|First Posted Date ICMJE||March 26, 2019|
|Last Update Posted Date||September 9, 2020|
|Actual Study Start Date ICMJE||February 26, 2019|
|Estimated Primary Completion Date||December 31, 2022 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Self-Care for Older People With Diabetes Mellitus|
|Official Title ICMJE||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.
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:
i. 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.
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.
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.
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 Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
|Condition ICMJE||Diabetes Mellitus, Type 2|
|Study Arms ICMJE||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Estimated Study Completion Date ICMJE||December 31, 2022|
|Estimated Primary Completion Date||December 31, 2022 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages ICMJE||55 Years to 99 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Listed Location Countries ICMJE||Singapore|
|Removed Location Countries|
|NCT Number ICMJE||NCT03890991|
|Other Study ID Numbers ICMJE||H-18-074|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||
|IPD Sharing Statement ICMJE||
|Responsible Party||Raymond Boon Tar Lim, National University, Singapore|
|Study Sponsor ICMJE||National University, Singapore|
|Collaborators ICMJE||Tsao Foundation Singapore|
|Investigators ICMJE||Not Provided|
|PRS Account||National University, Singapore|
|Verification Date||September 2020|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP