Skip to content

The Development, Feasibility, and Acceptability of an Individual and Family Self-Management Intervention to Prevent Dementia among Older Adults with Type 2 Diabetes in the Community: A Co-Design Approach

The Development, Feasibility, and Acceptability of an Individual and Family Self-Management Intervention to Prevent Dementia among Older Adults with Type 2 Diabetes in the Community: Stakeholder Perspectives, Co-Design Approach, and Implementation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250921003
Enrollment
166
Registered
2025-09-21
Start date
2025-09-13
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Older adult with Type 2 Diabetes dementia preventive behaviors diabetes Co design IFSMT older adults Double diamond

Interventions

The Discover phase using a cross sectional study and qualitative study aims to understand the problem or issue regarding dementia self management preventive behaviors and the Individual and Family Sel
Individual and Family Self Management to Prevent Dementia Program,Usual Care

Sponsors

Faculty of Nursing, Chiang Mai University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 69 Years

Inclusion criteria

Inclusion criteria: Cross sectional study in Phase 1 Discover The inclusion criteria for older adults with type 2 diabetes mellitus are Receiving treatment with oral hypoglycemic medication or insulin. Living with family members such as a spouse, children, or relatives. Having a baseline Activities of Daily Living Scale score above 12, indicating independent self care. Having a baseline MSET10 score above 8, indicating no significant cognitive impairment. Able to read, write, and communicate in Thai. Having no visual impairment or severe hearing impairment that would interfere with participation. Able to understand the study procedures and provide written informed consent. Qualitative study in Phases 1 to 3 Discover Define and Develop The inclusion criteria for older adults with type 2 diabetes mellitus are Receiving treatment with oral hypoglycemic medication or insulin. Living with family members such as a spouse, children, or relatives. Having a baseline Activities of Daily Living Scale score above 12, indicating independent self care. Having a baseline MSET10 score above 8, indicating no significant cognitive impairment. Able to read, write, and communicate in Thai. Having no visual impairment or severe hearing impairment that would interfere with participation. Able to understand the study procedures and provide written informed consent. The inclusion criteria for family members are Having experience caring for an older adult with type 2 diabetes mellitus for at least six months. Living in the same household as the older adult with type 2 diabetes mellitus. Able to read, write, and communicate in Thai. Having no visual impairment or severe hearing impairment that would interfere with participation. Able to understand the study procedures and provide written informed consent. The inclusion criteria for healthcare providers are Having at least six months of experience providing care for older adults with type 2 diabetes mellitus. Able to read, write, and communicate in Thai. Having no visual impairment or severe hearing impairment that would interfere with participation. Able to understand the study procedures and provide written informed consent. Deliver phase Intervention refinement and feasibility assessment The inclusion criteria for older adults with type 2 diabetes mellitus are Having participated in the previous co design phases of the study. Able to read, write, and communicate in Thai. Having no visual impairment or severe hearing impairment that would interfere with participation. Able to understand the study procedures and provide written informed consent. The inclusion criteria for family members are Having participated in the previous co design phases of the study. Able to read, write, and communicate in Thai. Having no visual impairment or severe hearing impairment that would interfere with participation. Able to understand the study procedures and provide written informed consent. The inclusion criteria for healthcare providers are Having participated in the previous co design phases of the study. Able to read, write, and communicate in Thai. Having no visual impairment or severe hearing impairment that would interfere with participation. Able to understand the study procedures and provide written informed consent. Pilot two arm randomized controlled trial The inclusion criteria for older adults with type 2 diabetes mellitus are Diagnosed with type 2 diabetes m

Exclusion criteria

Exclusion criteria: 1. A cross-sectional study in Phase 1 (Discover) The exclusion criteria of older adults with T2DM will be 1) diagnosis of depression, stroke, or Parkinson's disease 2) history (or family history) of dementia, brain infection, brain injury, or psychiatric illness 2. A qualitative study in Phase 1 3 (Discover, Define, and Develop) The exclusion criteria of older adults with T2DM will be 1) diagnosis of depression, stroke, or Parkinson's disease 2) history (or family history) of dementia, brain infection, brain injury, or psychiatric illness 3. A pilot two-arm randomized controlled trial (RCT) study in Phase 4 (Deliver) The exclusion criteria of older adults with T2DM will be 1) diagnosis of depression, stroke, or Parkinson s disease 2) history (or family history) of dementia, brain infection, brain injury, or psychiatric illness The discontinuation criteria of older adults with T2DM will be 1) unable to participate in at least 80% of the scheduled program activities The discontinuation criteria of family members of older adults with T2DM will be 1) unable to participate in at least 80% of the scheduled program activities

Design outcomes

Primary

MeasureTime frame
Feasibility at 12 weeks after end of the intervention the proportion of participants that complete baseline measures, complete treatment (attending for a minimum of 80%), and complete follow-up measures (immediately post intervention).,Acceptability at 12 weeks after end of the intervention using the Satisfaction with Intervention Questionnaire

Secondary

MeasureTime frame
Preliminary efficacy of Individual and Family Self-Management intervention at 12 weeks after end of the intervention HbA1C, MoCA, Individual and Family Self-Management Process, and dementia prevention behavior.

Countries

Thailand

Contacts

Public ContactNoppamas Sripetchwandee

Faculty of Nursing, Chiang Mai University

noppamas.p@cmu.ac.th0910688879

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026