Self-Care for Older People With Diabetes Mellitus

NCT03890991 | Unknown

• 1 other identifier: H-18-074
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Intervention; Self-efficacy; Diabetes Self-care Activities; Self-Monitoring of Blood Glucose; Diabetes; Community; Older people with diabetes

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months

Secondary Outcomes (8)

• Diabetes-specific quality of life measured using the Audit of Diabetes-Dependent Quality of Life

  6 months

• Participants' level of knowledge of Diabetes assessed using the Revised Michigan Diabetes Knowledge Questionnaire

  6 months

• Participants' level of medication adherence assessed using Medication Adherence Report Scale

  6 months

• Proportion of participants with optimal Glycated haemoglobin Level (HbA1c Level) of 7% or lower

  6 months

• Proportion of participants with optimal Systolic and Diastolic Blood Pressure

  6 months

Study Arms (4)

SCOPE-DM only

EXPERIMENTAL

Participation in SCOPE-DM programme without supply of glucometers and accessories

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

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.

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

Interventions

SCOPE-DM BEHAVIORAL

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 only

SCOPE-DM with 3 months' supply of glucometer BEHAVIORAL

Participants in this arm will participate in the SCOPE-DM programme and use the glucometer for 3 months.

SCOPE-DM with 3 months' supply of glucometer

SCOPE-DM with 6 months' supply of glucometer BEHAVIORAL

Participants in this arm will participate the in SCOPE-DM programme and use the glucometer for 6 months.

SCOPE-DM with 6 months' supply of glucometer

Eligibility Criteria

• Age: 55 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with type 2 diabetes mellitus
• Aged 55 to 99 years old (both inclusive)
• Community-dwelling

You may not qualify if:

• Individuals with Type 1 diabetes mellitus
• Unable to communicate independently in English or Mandarin
• Mentally incapacitated individuals

Sponsors & Collaborators

• National University of Singapore: lead
• Tsao Foundation Singapore: collaborator

Study Sites (1)

Whampoa Community Club

Singapore, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 26, 2019
• Study Start: February 26, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)