Community Occupational TherapyNCT00295152
Effects of Community Occupational Therapy in Older Patients With Dementia and Their Caregivers.
A study testing community occupational therapy in dementia in people with Community Occupational Therapy and Dementia Patients, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine the effects of community occupational therapy in older patients with mild ot moderate dementia and their primary caregivers. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Community Occupational Therapy, Dementia Patients, Primary Caregivers of Dementia Patients
- What is being tested?
- community occupational therapy in dementia
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 135 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2001to Feb 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- aged 65 years or older
- mild to moderate dementia (MMSE 10-24)
- living in the community at maximum of 50 kilometers from the Memory Clinic
- having an informal primary caregiver who was involved in the care for the patient at least once a week
Who cannot join
- depression: score > 12 on the Geriatric Depression Scale
- severe behavioral or psychological symptoms in dementia (BPSD) judged by a geriatrician
- severe illnesses, judged by a geriatrician
- no OT goals, determined by the researcher or research assistant
- caregivers having severe illnesses
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Memory Clinic and Geriatic Department Radboud University Nijmegen Medical Centre
Nijmegen, PO Box 9101, 6500 HB
About this study
Official title: Effects of Community Occupational Therapy on the Daily Performance of Older Patients With Mild to Moderate Dementia and on the Sense of Competence of Their Primary Caregivers.
The purpose of this study is to determine the effects of community occupational therapy in older patients with mild ot moderate dementia and their primary caregivers.
Read the detailed description
- Objective To determine the effects of community occupational therapy on the daily performance of older patients with mild to moderate dementia and the sense of competence of their primary caregivers.
- Methods
- design: a randomized controlled single-blind design is used with 3 measurement moments. We measure at baseline (before start of OT intervention), after 6 weeks (the effect measurement)and after 3 months after baseline (follow-up measurement).
- patients: 135 patients and their primary caregivers are needed to determine effects on the primary outcome measures of this intervention, with a power of 80% and alpha = 0.05/3. This power calculation is based on the outcomes of a pilot study (Graff, et al., 2003).
- intervention: 5 weeks client-centered community occupational therapy directed at both patients and primary caregivers using an OT guideline.The control group receives no OT intervention, but usual care.
- main outcome measures are: Assessment of Motor and Process Skills, Interview in Deterioration of Daily Activities in Dementia (IDDD)and Sense of Competence Questionnaire (SCQ)
- Analysis: analyses of covariance on intention-to-treat basis (Last Observation Carried Forward (LCOF))will be used to determine the effects of community OT on the daily performance of older patients with dementia and the sense of competence of their primary caregivers. Also secondary patients'and caregivers' health outcomes will be analyzed by analyses of covariance on intention-to-treat basis.
- Cost-effectiveness: the costs of this OT intervention will also be determined and a cost-effectiveness analysis will be carried out. 3)Results: Results at baseline, at 6 weeks and at 3 months follow-up on primary outcome measures and on patients' and caregivers' secondary health outcomes and also the cost effectiveness of this intervention, will be analyzed and described in international publications.
- Conditions
- Community Occupational Therapy, Dementia Patients, Primary Caregivers of Dementia Patients
- Being tested
- community occupational therapy in dementia
- Keywords
- elderly/aged, occupational therapy, daily activities, caregivers, sense of competence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
community occupational therapy in dementiaBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
1.process skills scores of the patients on the Assessment of Motor and Process Skills (AMPS);
2. performance scores in daily activities of the patients on the Interview of Deterioration in Daily Activities in Dementia (IDDD);
3. Sense of competence scores of the primary caregivers on the Sense of Competence Questionnaire (SCQ).
Secondary outcomes (14)
Patients:
1. motor skills scores on the AMPS
2. initiative in performing daily activities on the IDDD
3. general health scores on the General Health Questionnaire (GHQ-12)
4.Quality of life scored on the Dementia Quality of Life Instrument (DQOL)
5. Self-perception scores in occupational performance and satisfaction scores with this performance, scored on the Canadian Occupational Performance Measurement (COPM)
6. Mood/depression scored on the Cornell Depression Scale (CDS)
Caregiver:
1. mastery skills scored on the Mastery Scale
2. general health scores on the GHQ-12
3. quality of life scores on the DQOL
4. self-perception scores in occupational performance and satisfaction scores on the COPM
5. mood/depression scores on the Center for Epidemiologic Studies Depression Scales (Ces-D)
6. Copings skills scores on the JCS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2006 (estimated)
- Study startApr 2001
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Community Occupational TherapyStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 135 participants
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association, VCVGZ Fund;, Dutch Occupational Therapy Association
- Investigators
- Marcel GM Olde-Rikkert, PhD, MD, Principal investigator, Department of Geriatrics Radboud University Nijmegen Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295152
- Sponsor's protocol ID
- EDO project
- Other IDs
- Grant V-1999-023.
- Status last verified
- Feb 2006
- First submitted
- 21 Feb 2006
- Last updated
- 17 Nov 2011
- Results posted
- No
Publications
Gitlin LN, Winter L, Corcoran M, Dennis MP, Schinfeld S, Hauck WW. Effects of the home environmental skill-building program on the caregiver-care recipient dyad: 6-month outcomes from the Philadelphia REACH Initiative. Gerontologist. 2003 Aug;43(4):532-46. doi: 10.1093/geront/43.4.532.
PubMed 12937332Steultjens EM, Dekker J, Bouter LM, Jellema S, Bakker EB, van den Ende CH. Occupational therapy for community dwelling elderly people: a systematic review. Age Ageing. 2004 Sep;33(5):453-60. doi: 10.1093/ageing/afh174.
PubMed 15315918Vernooij-Dassen MJ, Felling AJ, Brummelkamp E, Dauzenberg MG, van den Bos GA, Grol R. Assessment of caregiver's competence in dealing with the burden of caregiving for a dementia patient: a Short Sense of Competence Questionnaire (SSCQ) suitable for clinical practice. J Am Geriatr Soc. 1999 Feb;47(2):256-7. doi: 10.1111/j.1532-5415.1999.tb04588.x. No abstract available.
PubMed 9988301Vernooij-Dassen M, Lamers C, Bor J, Felling A, Grol R. Prognostic factors of effectiveness of a support program for caregivers of dementia patients. Int J Aging Hum Dev. 2000;51(4):259-74. doi: 10.2190/P8L1-N8QD-VTJ4-EURT.
PubMed 11246648Teunisse S, Derix MM. The interview for deterioration in daily living activities in dementia: agreement between primary and secondary caregivers. Int Psychogeriatr. 1997;9 Suppl 1:155-62. doi: 10.1017/s1041610297004845.
PubMed 9447438Graff MJL, et al.Occupational therapy at home for older individuals with mild to moderate cognitive impairments and their primary caregivers: a pilot study. Occupational Therapy Journal of Research 23, 155-163, 2003.
Graff MJL, Melick van MBM. The development, testing and implementation of an occupational therapy guideline. The guideline for the OT diagnosis and treatment of older persons with cognitive impairments. Ducth Occupational Therapy Journal 28, 169-174, 2000.
Melick van MBM, Graff MJL. Occupational therapy for geriatric patients. The guideline for occupational therapy in geriatric patients with mild to moderate cognitive impairments. Dutch Journal of Occupational Therapy 28, 176-181, 2000
Graff MJL, et al. How can occupational therapy improve the daily performance and communication of an older patient with dementia and his primary caregiver: a case study. Dementia: the journal of social research and practice. 2006. In press.
Graff MJ, Vernooij-Dassen MJ, Thijssen M, Dekker J, Hoefnagels WH, Rikkert MG. Community based occupational therapy for patients with dementia and their care givers: randomised controlled trial. BMJ. 2006 Dec 9;333(7580):1196. doi: 10.1136/bmj.39001.688843.BE. Epub 2006 Nov 17.
PubMed 17114212
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Community Occupational Therapy on the Daily Performance of Older Patients With Mild to Moderate Dementia and on the Sense of Competence of Their Primary Caregivers.
- ClinicalTrials.gov ID
- NCT00295152
- Acronym / sponsor ID
- EDO project
- Conditions
- Community Occupational Therapy, Dementia Patients, Primary Caregivers of Dementia Patients
- Keywords
- elderly/aged, occupational therapy, daily activities, caregivers, sense of competence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Alzheimer's Association, VCVGZ Fund;, Dutch Occupational Therapy Association
- Study start
- Apr 2001
- Study completion
- Feb 2005
- First posted
- 22 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of community occupational therapy in older patients with mild ot moderate dementia and their primary caregivers.
Detailed description
- Objective To determine the effects of community occupational therapy on the daily performance of older patients with mild to moderate dementia and the sense of competence of their primary caregivers.
- Methods
- design: a randomized controlled single-blind design is used with 3 measurement moments. We measure at baseline (before start of OT intervention), after 6 weeks (the effect measurement)and after 3 months after baseline (follow-up measurement).
- patients: 135 patients and their primary caregivers are needed to determine effects on the primary outcome measures of this intervention, with a power of 80% and alpha = 0.05/3. This power calculation is based on the outcomes of a pilot study (Graff, et al., 2003).
- intervention: 5 weeks client-centered community occupational therapy directed at both patients and primary caregivers using an OT guideline.The control group receives no OT intervention, but usual care.
- main outcome measures are: Assessment of Motor and Process Skills, Interview in Deterioration of Daily Activities in Dementia (IDDD)and Sense of Competence Questionnaire (SCQ)
- Analysis: analyses of covariance on intention-to-treat basis (Last Observation Carried Forward (LCOF))will be used to determine the effects of community OT on the daily performance of older patients with dementia and the sense of competence of their primary caregivers. Also secondary patients'and caregivers' health outcomes will be analyzed by analyses of covariance on intention-to-treat basis.
- Cost-effectiveness: the costs of this OT intervention will also be determined and a cost-effectiveness analysis will be carried out. 3)Results: Results at baseline, at 6 weeks and at 3 months follow-up on primary outcome measures and on patients' and caregivers' secondary health outcomes and also the cost effectiveness of this intervention, will be analyzed and described in international publications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- aged 65 years or older
- mild to moderate dementia (MMSE 10-24)
- living in the community at maximum of 50 kilometers from the Memory Clinic
- having an informal primary caregiver who was involved in the care for the patient at least once a week
Key exclusion criteria (5 listed)
- depression: score > 12 on the Geriatric Depression Scale
- severe behavioral or psychological symptoms in dementia (BPSD) judged by a geriatrician
- severe illnesses, judged by a geriatrician
- no OT goals, determined by the researcher or research assistant
- caregivers having severe illnesses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| community occupational therapy in dementia | Behavioural | – |
Primary outcome
1.process skills scores of the patients on the Assessment of Motor and Process Skills (AMPS);
2. performance scores in daily activities of the patients on the Interview of Deterioration in Daily Activities in Dementia (IDDD);
3. Sense of competence scores of the primary caregivers on the Sense of Competence Questionnaire (SCQ).
14 secondary outcomes
Patients:
1. motor skills scores on the AMPS
2. initiative in performing daily activities on the IDDD
3. general health scores on the General Health Questionnaire (GHQ-12)
4.Quality of life scored on the Dementia Quality of Life Instrument (DQOL)
5. Self-perception scores in occupational performance and satisfaction scores with this performance, scored on the Canadian Occupational Performance Measurement (COPM)
6. Mood/depression scored on the Cornell Depression Scale (CDS)
Caregiver:
1. mastery skills scored on the Mastery Scale
2. general health scores on the GHQ-12
3. quality of life scores on the DQOL
4. self-perception scores in occupational performance and satisfaction scores on the COPM
5. mood/depression scores on the Center for Epidemiologic Studies Depression Scales (Ces-D)
6. Copings skills scores on the JCS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2011.
- Background: PubMed 12937332Gitlin LN, Winter L, Corcoran M, Dennis MP, Schinfeld S, Hauck WW. Effects of the home environmental skill-building program on the caregiver-care recipient dyad: 6-month outcomes from the Philadelphia REACH Initiative. Gerontologist. 2003 Aug;43(4):532-46. doi: 10.1093/geront/43.4.532.
- Background: PubMed 15315918Steultjens EM, Dekker J, Bouter LM, Jellema S, Bakker EB, van den Ende CH. Occupational therapy for community dwelling elderly people: a systematic review. Age Ageing. 2004 Sep;33(5):453-60. doi: 10.1093/ageing/afh174.
- Background: PubMed 9988301Vernooij-Dassen MJ, Felling AJ, Brummelkamp E, Dauzenberg MG, van den Bos GA, Grol R. Assessment of caregiver's competence in dealing with the burden of caregiving for a dementia patient: a Short Sense of Competence Questionnaire (SSCQ) suitable for clinical practice. J Am Geriatr Soc. 1999 Feb;47(2):256-7. doi: 10.1111/j.1532-5415.1999.tb04588.x. No abstract available.
- Background: PubMed 11246648Vernooij-Dassen M, Lamers C, Bor J, Felling A, Grol R. Prognostic factors of effectiveness of a support program for caregivers of dementia patients. Int J Aging Hum Dev. 2000;51(4):259-74. doi: 10.2190/P8L1-N8QD-VTJ4-EURT.
- Background: PubMed 9447438Teunisse S, Derix MM. The interview for deterioration in daily living activities in dementia: agreement between primary and secondary caregivers. Int Psychogeriatr. 1997;9 Suppl 1:155-62. doi: 10.1017/s1041610297004845.
- Results publicationGraff MJL, et al.Occupational therapy at home for older individuals with mild to moderate cognitive impairments and their primary caregivers: a pilot study. Occupational Therapy Journal of Research 23, 155-163, 2003.
- Results publicationGraff MJL, Melick van MBM. The development, testing and implementation of an occupational therapy guideline. The guideline for the OT diagnosis and treatment of older persons with cognitive impairments. Ducth Occupational Therapy Journal 28, 169-174, 2000.
- Results publicationMelick van MBM, Graff MJL. Occupational therapy for geriatric patients. The guideline for occupational therapy in geriatric patients with mild to moderate cognitive impairments. Dutch Journal of Occupational Therapy 28, 176-181, 2000
- Results publicationGraff MJL, et al. How can occupational therapy improve the daily performance and communication of an older patient with dementia and his primary caregiver: a case study. Dementia: the journal of social research and practice. 2006. In press.
- Derived from this study: PubMed 17114212Graff MJ, Vernooij-Dassen MJ, Thijssen M, Dekker J, Hoefnagels WH, Rikkert MG. Community based occupational therapy for patients with dementia and their care givers: randomised controlled trial. BMJ. 2006 Dec 9;333(7580):1196. doi: 10.1136/bmj.39001.688843.BE. Epub 2006 Nov 17.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcel GM Olde-Rikkert, PhD, MD principal investigator
Department of Geriatrics Radboud University Nijmegen Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing community occupational therapy in dementia in people with Community Occupational Therapy and Dementia Patients, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.process skills scores of the patients on the Assessment of Motor and Process Skills (AMPS);. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00295152, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2011; AzTrials last refreshed its copy on 7 Nov 2026.