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

Improving outcomes in patients with coexisting multi-morbid conditions – the development and evaluation of the combined diabetes and renal control feasibility trial (C-DIRECT)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10546597

Enrollment

Registered

2016-09-14

Start date

2016-05-01

Completion date

Unknown

Last updated

2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 adjustment

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Singapore

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026