Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT01183351
Status:
COMPLETED
Last Update Posted:
2014-12-12
First Post:
2010-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multidisciplinary Intervention for Challenging Behaviour (Agitation) in Patients With Dementia
Sponsor:
Sykehuset Innlandet HF
Organization:
Study Overview
Official Title:
Pilot Study of a Multidisciplinary Intervention for Challenging Behaviour (Agitation) in Patients With Dementia
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TID
Brief Summary:
The increasing prevalence of dementia is a major challenge to the health authorities in most countries. Nearly all the persons suffering from dementia experience behavioural and psychological symptoms (BPSD). The prevalence of BPSD is particularly high in nursing homes. BPSD are often treated with psychotropic drugs even though the evidence for effect is minimal and the risk of serious adverse events is considerable. All the major treatment recommendations advise that non-pharmacological measures should be applied first when treating BPSD even though the evidence for such treatment is limited. The investigators will conduct a pilot study of a non-pharmacological treatment for BPSD. The method has been developed in Norway and has already been implemented in a number of nursing homes in the county of Nordland.
Detailed Description:
Intervention description:
Initially the intervention group will receive education about dementia, BPSD, quality of care and use of psychotropic drugs Subsequently, staff in the nursing home will receive training in the intervention method: MID. Two or three nurses from each nursing home will receive more intensive training in the method to ensure effective implementation of the method in daily practice. After this initial period that will last for four weeks, trained research nurses will visit each nursing home every fortnight ensuring that the intervention is properly implemented and thereby assure adherence to the treatment protocol.
Description of the intervention Multidisciplinary Intervention model for challenging behaviour in Dementia, MID, consists of three stages: a registration-observation stage, a staff guiding stage, and an evaluation stage.
1. Registration-observation stage:
The nurses use a daily registration sheet for the actual types of behaviour that are challenging. This ensures that the behaviour is properly observed on a daily basis.
The next step in the registration-observation stage is:
* Collection of the medical history by the nursing home nurses
* Standard physical examination by the nursing home physician
* Critical review of medication by the nursing home physician
* Pain assessment (clinical), by the nursing home physician
* Assessment of the type and degree of dementia by the nursing home physician
* Assembly of the patients personal history by the nursing homes nurses After completion of the registration-observation stage (lasting 1 day up to 4 weeks) the staff guiding stage starts.
2. Staff guiding stage - guiding meeting The trained nurses from the nursing home set a meeting for 1-1,5 hours for the nursing home health workers. The meeting is lead by the nursing home nurses and the nursing home physician.
The meeting follows a structured agenda and is conducted following the principles of problem solving in cognitive behavioural therapy taking into account one type of challenging behaviour at a time. Results from the registration-observation stage are presented at the beginning of the meeting. (A 5-column sheet, based on classical cognitive change thoughts records, is used to structure problem solving during the meeting: 1.facts, 2.interpretations (thoughts), 3.feelings, 4. solutions/actions and 5. evaluation)
3. Evaluation stage This stage starts just after the guiding meeting and is conducted by the nursing home nurses. The nurses continue the same registration of the behaviour on a daily basis as in the registration-observation stage for the next 4 weeks.
Initially the intervention group will receive education about dementia, BPSD, quality of care and use of psychotropic drugs Subsequently, staff in the nursing home will receive training in the intervention method: MID. Two or three nurses from each nursing home will receive more intensive training in the method to ensure effective implementation of the method in daily practice. After this initial period that will last for four weeks, trained research nurses will visit each nursing home every fortnight ensuring that the intervention is properly implemented and thereby assure adherence to the treatment protocol.
Description of the intervention Multidisciplinary Intervention model for challenging behaviour in Dementia, MID, consists of three stages: a registration-observation stage, a staff guiding stage, and an evaluation stage.
1. Registration-observation stage:
The nurses use a daily registration sheet for the actual types of behaviour that are challenging. This ensures that the behaviour is properly observed on a daily basis.
The next step in the registration-observation stage is:
* Collection of the medical history by the nursing home nurses
* Standard physical examination by the nursing home physician
* Critical review of medication by the nursing home physician
* Pain assessment (clinical), by the nursing home physician
* Assessment of the type and degree of dementia by the nursing home physician
* Assembly of the patients personal history by the nursing homes nurses After completion of the registration-observation stage (lasting 1 day up to 4 weeks) the staff guiding stage starts.
2. Staff guiding stage - guiding meeting The trained nurses from the nursing home set a meeting for 1-1,5 hours for the nursing home health workers. The meeting is lead by the nursing home nurses and the nursing home physician.
The meeting follows a structured agenda and is conducted following the principles of problem solving in cognitive behavioural therapy taking into account one type of challenging behaviour at a time. Results from the registration-observation stage are presented at the beginning of the meeting. (A 5-column sheet, based on classical cognitive change thoughts records, is used to structure problem solving during the meeting: 1.facts, 2.interpretations (thoughts), 3.feelings, 4. solutions/actions and 5. evaluation)
3. Evaluation stage This stage starts just after the guiding meeting and is conducted by the nursing home nurses. The nurses continue the same registration of the behaviour on a daily basis as in the registration-observation stage for the next 4 weeks.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: