NCT03741543

Brief Summary

The overall aim of this study is to investigate how home dwelling people with early-stage dementia cope with their disease, explored through their participation in a 12-week health promotion course, through 3 sub-studies; 1) The users' experience in gaining information about dementia and meeting others in the same situation, 2) observation of the group interactions and support processes, and 3) investigate the effect of the 12-week health promotion course for people with early stage dementia on their cognitive function, psychosocial function and health behaviour.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2014

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 15, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

5 years

First QC Date

November 6, 2018

Last Update Submit

May 13, 2025

Conditions

Keywords

health promotionearly-stage dementiapsychosocial

Outcome Measures

Primary Outcomes (1)

  • The users experiences from an educative intervention in early-stage dementia

    Qualitative data will be collected through semi-structured individual interviews with both participants and their caregiver (proxy), and through moderate participant observations following the participants over the duration of the 12-week course. The interview guide and observational protocol consist of pre-selected topics, including (1) communication, (2) participant engagement, (3) social interaction within the group, (4) peer support (5) change in perception of living with dementia and (6) educational outcome. The qualitative data will be explored using content analysis.

    Baseline, 3 months

Secondary Outcomes (7)

  • Change in cognitive function

    Baseline, 3 months

  • Change in depressive symptoms

    Baseline, 3 months

  • Change in self-rated health

    Baseline, 3 months

  • Change in managing personal activities of daily life

    Baseline, 3 months

  • Change in managing instrumental activities of daily life

    Baseline, 3 months

  • +2 more secondary outcomes

Study Arms (1)

A 12-week health promotion course

OTHER

The Health Promotion intervention consists of 12 weekly 2-hour sessions with a group of up to six participants and two course facilitators. Teaching methods includes lecture, questions- and answer periods, and interactive hands-on learning. During the class sessions, the facilitators encourages the participants to ask questions and make comments about the lecture at any time. During the first class session, each participant receives a booklet with the course material

Other: A 12-week health promotion course

Interventions

The Health Promotion intervention consists of 12 weekly 2-hour sessions with a group of up to six participants and two course facilitators. Teaching methods includes lecture, questions- and answer periods, and interactive hands-on learning. During the class sessions, the facilitators encourages the participants to ask questions and make comments about the lecture at any time. During the first class session, each participant receives a booklet with the course material.

Also known as: Psychosocial intervention, group based
A 12-week health promotion course

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • years of age or older
  • A diagnosis of early or moderate stage dementia
  • Capable of reading and writing
  • Hearing and vision which are sufficiently good to work in a group setting
  • Proficient in the language in which the course is provided

You may not qualify if:

  • A diagnosis of alcohol abuse
  • A limited life expectancy due to any terminal disease or other serious illness
  • Chemotherapy or radiation treatment ongoing at enrolment
  • Head injuries
  • Epilepsy
  • Parkinson's disease
  • A history of psychiatric illness
  • A history of a diagnosis of subnormal intelligence
  • Prior participation in health promotion or cognitive training programs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Buettner LL, Fitzsimmons S. Promoting health in early-stage dementia: evaluation of a 12-week course. J Gerontol Nurs. 2009 Mar;35(3):39-49. doi: 10.3928/00989134-20090301-02.

    PMID: 19326828BACKGROUND
  • Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Cornell Scale for Depression in Dementia. Biol Psychiatry. 1988 Feb 1;23(3):271-84. doi: 10.1016/0006-3223(88)90038-8.

    PMID: 3337862BACKGROUND
  • Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.

    PMID: 5349366BACKGROUND
  • EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

    PMID: 10109801BACKGROUND
  • Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.

    PMID: 7991117BACKGROUND
  • Testad I, Kajander M, Gjestsen MT, Dalen I. Health promotion intervention for people with early-stage dementia: A quasi-experimental study. Brain Behav. 2020 Dec;10(12):e01888. doi: 10.1002/brb3.1888. Epub 2020 Oct 16.

  • Kajander, M., Gjestsen, M. T., Vagle, V., Meling, M., Henriksen, A. T., & Testad, I. (2022). Health promotion in early-stage dementia-user experiences from an educative intervention. Educational Gerontology, 48(9), 391-403.

    RESULT
  • Kajander M, Gjestsen MT, Ballard C, Naess H, Testad I. Health Promotion in Early-Stage Dementia: A Focused Ethnographic Study of a 12-Week Group-Based Educational Intervention. SAGE Open Nurs. 2024 Jul 25;10:23779608241266686. doi: 10.1177/23779608241266686. eCollection 2024 Jan-Dec.

  • Kajander M, Gjestsen M T, Ballard C, Naess H, Tovar-Rios D A, Fossey J, Testad I. Health promotion in early-stage dementia: Exploring associations between sociodemographic characteristics and outcomes of a 12-week group-based educational intervention. Educational Gerontology. 2024; 1-14. doi: https://doi.org/10.1080/03601277.2024.2358620

    RESULT

MeSH Terms

Conditions

DementiaAlzheimer DiseaseDementia, Vascular

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative DiseasesCerebrovascular DisordersIntracranial ArteriosclerosisIntracranial Arterial DiseasesLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ingelin Testad, PhD

    Helse Stavanger

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: a 12-week health promotion course
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2018

First Posted

November 15, 2018

Study Start

March 3, 2014

Primary Completion

February 28, 2019

Study Completion

December 31, 2024

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share