Improving outcomes in patients with diabetes and on dialysis – A brief intervention to support self-care and adjustment

• Register: ISRCTN
• Last refreshed on: 3 March 2020
• Main ID: ISRCTN10546597
• Date of registration: 14/09/2016
• Prospective Registration: No
• Primary sponsor: National University of Singapore
• Public title: Improving outcomes in patients with diabetes and on dialysis – A brief intervention to support self-care and adjustment
• Scientific title: Improving outcomes in patients with coexisting multi-morbid conditions – the development and evaluation of the combined diabetes and renal control feasibility trial (C-DIRECT)
• Date of first enrolment: 01/05/2016
• Target sample size: 44
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN10546597
• Study type: Interventional
• Study design: Feasibility parallel arm blinded randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Singapore

Contacts

• Name: Konstadina Griva

Key inclusion & exclusion criteria

Inclusion criteria:
1. Aged 21 years or over
2. Diagnosed with type 1 or type 2 diabetes and End Stage Renal Disease
3. Receive hospital haemodialysis three times for a minimum of 3 months
4. Hb1Ac = >8%.

Exclusion criteria:
1. Suffering from severe mental illness e.g. psychosis
2. Insufficient communication skills in the English, Malay or Chinese language to participate in the intervention
3. Any other severe communication difficulties that would prevent them following study procedures


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Coexisting Diabetes Mellitus and End Stage Renal Disease
Nutritional, Metabolic, Endocrine
Coexisting Diabetes Mellitus and End Stage Renal Disease

Intervention(s)

Participants are randomised to one of two groups in a 1:1 allocation ratio.

Intervention group: Participants will take part in a brief nurse led program designed to support adjustments to the lifestyle changes required by diabetes patients on hemodialysis. This will involve 3 visits by the NKF diabetes link nurses during one of their regular dialysis sessions at the dialysis center. During these sessions, the nurses will support patients in setting goals and will provide education around diet, medication, exercise, foot care or blood sugar monitoring, if they so require (based on Elicit-Provide-Elicit framework in Motivational Interviewing). The contents of the sessions will be tailored to their needs and preferences for support. Participants will decide the direction and content of these empowering conversations. A self-management record sheet will be used as part of the consultation. DM Link renal nurses and patients work together to complete the sheet in each session. Focus of each session, goal setting and confidence will be recorded. These visits will take approximately 30 minutes and will be scheduled over 3 consecutive weeks.

Control group: Participants will receive standard care for the duration of the study.

Assessment procedures are identical for control and intervention participants . These include a baseline assessment (self report questionnaires listed) and follow up assessment (12 weeks post baseline) - this is approximately 2-4 weeks post completion of the C-DIRECT intervention. Follow up assessments include same set of questionnaires (C-DRECT participants will also be invited to participate in a brief interview on their experience of the program).

Primary Outcome(s)

1. HbA1c and home glucose monitoring records
2. Biochemical markers (phosphate & potassium levels)
3. Protein catabolic rate, albumin, hemoglobin
4. Interdialytic weight gains v) blood pressure readings

Secondary Outcome(s)

1. Generic and diabetes specific distress is measured using the Hospital Anxiety and Depression Scale and Problem Areas in Diabetes Scale at baseline and 4 weeks post intervention
2. Health related Quality of Life is measured using the Kidney Disease Quality of Life Short Form at baseline and 2/4 weeks post intervention
3. Self-reported adherence/self-care is measured using the Dialysis Diet and Fluid Non-Adherence Questionnaire, Summary of 2/4. Diabetes Self-Care Activities and self-report adherence items developed for study at baseline and 2-4 weeks post intervention
4. Self-Management Skills are measured using the Self Efficacy Scale and Health Education Impact Questionnaire at baseline and 2/4 weeks post intervention
5. Experiences of the intervention are measured through qualitative interviews with intervention participants 4 weeks post intervention

Secondary ID(s)

N/A

Source(s) of Monetary Support

National Kidney Foundation Singapore

Ethics review

Status:
Approval date:
Contact:

National University of Singapore Institutional Review Board, 01/04/2016, ref: 13-394

Results

• Results available: Yes
• Date Completed: 31/12/2016