NCT06448338

Brief Summary

The UK MyREMEDY study investigates whether MyDiaMate, an online self-help program, can effectively improve the mental health of adults with type 1 diabetes compared to those receiving care as usual.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2024

Completed
24 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 10, 2024

Status Verified

June 1, 2024

Enrollment Period

1.4 years

First QC Date

June 3, 2024

Last Update Submit

June 7, 2024

Conditions

Type 1 DiabetesDiabetes Distress

Outcome Measures

Primary Outcomes (1)

  • Diabetes Distress

    Diabetes Distress will be assessed through the 20-item Problem Areas In Diabetes questionnaire (PAID-20). The PAID questionnaire measures diabetes distress on a 5-point Likert scale ranging from 1 (not a problem) to 5 (serious problem). A higher score represents higher diabetes distress.

    Diabetes Distress will be assessed at 0 months (baseline), 3 months (intervention effects), and after 6 months (follow-up).

Secondary Outcomes (8)

  • Emotional well-being

    Emotional well-being will be assessed at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up).

  • Psychological self-efficacy in relation to diabetes

    Psychological self-efficacy in relation to diabetes will be assessed at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up).

  • Social engagement

    Social engagement will be measured at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up).

  • Fatigue

    Fatigue will be measured at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up).

  • HbA1c

    HbA1c will be self-reported at 0 months (baseline), 3 months (intervention effect), and 6 months (follow-up).

  • +3 more secondary outcomes

Study Arms (2)

MyDiaMate

EXPERIMENTAL

2/3 of participants will be randomized into this arm. They will receive access to MyDiaMate for 6 months.

Behavioral: MyDiaMate

Care as Usual

NO INTERVENTION

1/3 of participants will be randomized into this arm. They will continue their care as usual for 3 months. After 3 months, they receive access to MyDiaMate if desired.

Interventions

MyDiaMateBEHAVIORAL

MyDiaMate program

MyDiaMate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years old at signing the informed consent form
  • Type 1 diabetes diagnosis at least 6 months ago
  • Having access to the internet and a smartphone/tablet/laptop/computer for the entirety of study participation
  • Experiencing diabetes distress (checked during a phone call between research assistant and participant. The condition is met if the participant has an average score of ≥2 on the 2-item Diabetes Distress Scale \[DDS-2\], representing clinically meaningful diabetes distress)

You may not qualify if:

  • Having been diagnosed with a psychiatric disorder in the past 6 months for which the person is under psychological/psychiatric treatment
  • Suicidality
  • Having started a treatment with psychotropic medication in the past 3 months
  • Cannot read and speak English
  • Experience of cognitive problems that hamper using MyDiaMate or vision/auditory problems that are hindering in daily life

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Kirsty Winkley, PhD

CONTACT

+447879625607MyREMEDY@kcl.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2024

First Posted

June 7, 2024

Study Start

July 1, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

June 10, 2024

Record last verified: 2024-06

Locations

GB(1)