Psychosocial support to adults with newly diagnosed type 1 diabetes

A feasibility study and process evaluation in Denmark of an integrated support programme for adults following a diagnosis of type 1 diabetes - the Living with and ADapting to DiabetEs Programme (LADDER)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12962681

Enrollment

Registered

2024-12-27

Start date

2021-01-29

Completion date

Unknown

Last updated

2025-01-06

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

Conditions

Type 1 diabetes Nutritional, Metabolic, Endocrine

Interventions

The purpose of the study is to test the feasibility of one component of the LADDER programme, the research design, and the study outcomes. The study is a non-randomised multicentre trial testing compo

person-centered counselling

and self-determination theory. The intervention consists of the use of three visual dialogue tools developed specifically for and by adults with new-onset T1D to address the psychological and social

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosed with type 1 diabetes within the last 3 months

Exclusion criteria

Exclusion criteria: 1. Severe physical or mental illness 2. Unable to engage in conversation with the dialogue tools 3. Unable to speak or understand Danish

Design outcomes

Primary

Measure	Time frame
The researchers have not identified an individual primary outcome for the feasibility study because the intervention has been modelled to affect multiple outcomes. They will use the following outcome measures: 1. General health is measured by SF-36 at baseline, 6 and 9 months 2. Acceptance is measured by the Illness Identity Questionnaire at 3, 6 and 9 months 3. Illness perception is measured by the Brief Illness Perception Questionnaire at baseline, 3, 6 and 9 months 4. Well-being/depression is measured by WHO-5 at baseline, 6 and 9 months 5. Diabetes distress is measured by Problem Areas in Diabetes Scale at 3,6, and 9 months 6. Diabetes resilience is measured by the Diabetes Empowerment Scale-short form at 3, 6, and 9 months 7. Interactions with health care professionals measured by health care climate questionnaire at baseline 8. Impact of diabetes on everyday life measured by DAWN questionnaire at baseline, 3 and 6 months and by SF-36 role function (physical and emotional) at baseline and 3 months 9. Social support is measured by experience in close relationships at baseline and by the DAWN questionnaire at baseline, 3 and 6 months 10. Perceived stress is measured by the perceived stress scale at baseline, 3 and 6 months 11.Engagement with diabetes care is measured by attendance at screening and diabetes appointments at the end of the study 12.Hypoglycaemia (blood glucose <3.5 mmol/L) and severe hypoglycaemic events (where third-party assistance is required) measured using data collected from patient medical records at the end of the study 13.Glycaemic control is measured by HbA1c at baseline, 3, 6 and 9 months	—

Measure

Time frame

The researchers have not identified an individual primary outcome for the feasibility study because the intervention has been modelled to affect multiple outcomes. They will use the following outcome measures: 1. General health is measured by SF-36 at baseline, 6 and 9 months 2. Acceptance is measured by the Illness Identity Questionnaire at 3, 6 and 9 months 3. Illness perception is measured by the Brief Illness Perception Questionnaire at baseline, 3, 6 and 9 months 4. Well-being/depression is measured by WHO-5 at baseline, 6 and 9 months 5. Diabetes distress is measured by Problem Areas in Diabetes Scale at 3,6, and 9 months 6. Diabetes resilience is measured by the Diabetes Empowerment Scale-short form at 3, 6, and 9 months 7. Interactions with health care professionals measured by health care climate questionnaire at baseline 8. Impact of diabetes on everyday life measured by DAWN questionnaire at baseline, 3 and 6 months and by SF-36 role function (physical and emotional) at baseline and 3 months 9. Social support is measured by experience in close relationships at baseline and by the DAWN questionnaire at baseline, 3 and 6 months 10. Perceived stress is measured by the perceived stress scale at baseline, 3 and 6 months 11.Engagement with diabetes care is measured by attendance at screening and diabetes appointments at the end of the study 12.Hypoglycaemia (blood glucose <3.5 mmol/L) and severe hypoglycaemic events (where third-party assistance is required) measured using data collected from patient medical records at the end of the study 13.Glycaemic control is measured by HbA1c at baseline, 3, 6 and 9 months

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Denmark

Contacts

Public ContactMette Due-Christensen

mdue0015@regionh.dk+45 (0)53575741

Outcome results

None listed

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