Trial · NCT01021696
Pain in Patients With Dementia and Behavioural Disturbances
NCT01021696, Phase 2, Phase 3, Completed, University of Bergen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pain in Patients With Dementia and Behavioural Disturbances. Trials, record NCT01021696. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01021696
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pain in Patients With Dementia and Behavioural Disturbances
- NCT number
- NCT01021696
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 352 participants, actual
- Lead sponsor
- University of Bergen
- Conditions
- Dementia, Pain, Agitation
- Interventions
- Paracetamol, Morphine, Buprenorphine plaster, Pregabalin
- First posted
- 2009-11-30
- Last updated
- 2011-08-10
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cohen-Mansfield Agitation Inventory - long form (CMAI) | CMAI will be used during the screening/inclusion process, at week 2, 4, 8, and 12. | CMAI has 29-item (max. score 203) to assess agitated behaviours in NH-patients. A six-point rating scale assesses the frequency with which patients manifest BPSD evaluating 29 agitated behaviours, ranging from never, less than once a week, but still occurring, once or twice a week, several times a week, once or twice a day, several times a day or several times an hour. Items are presented in four factors: I Aggressive behaviour; II Physical non-aggressive behaviour; III Verbally agitated behavior, IV hiding and hoarding. Ratings are based on face-to-face interviews with caregivers. |
| Secondary | Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) | NPI will be used during the inclusion process, at week 2, 4, 8, and 12. | NPI is a caregiver based interview (10 min.), assessing 10 BPSD and 2 neurovegetative areas with total score and subscales for: delusion, hallucination, agitation, depression, anxiety, disinhibition apathy, irritability, aberrant motor activity, sleep, appetite. Frequency, severity, and caregiver's distress are measured. The NH-version will be used, recently validated in Norwegian (AGS Panel 1998). A higher score reflects increased frequency and severity of the disturbances. |
| Secondary | Activity of Daily Living function (ADL) | ADL assessment will be used during clinical investigation related to the inclusion prosess and at week 8 | ADL assess physical function. Rating includes activities like feeding, moving, personal toilet, and dressing higher values indicating higher levels of activities of daily functioning and independency (Sheikh 1979). The scale includes 10 items (0-20 score). The ADL score is derived from caregiver interview. Administration of the ADL takes approximately 5 minutes. |
| Secondary | Mini Mental State Examination | Screening/clinical investigation and week 8 | The MMSE is a 30-point mental status examination scale that enables cut-off differentiation for levels of severity of cognitive impairment (Folstein 1975). Cut point for moderate dementia: \<20. The question consist of several orientation question (10 points), registration and recall task (6), attention task (5), three stage command (3), two naming task (2), repetition task (1), reading comprehension task (1), written sentence (1), and a visual construction (1). The test takes 15 minutes to administer and the patient is asked the questions directly by the examiner. |
| Secondary | Mobilisation-Observation-Behavior-Intensity-Dementia-2 (MOBID-2) Pain Scale | Screening/clinical investigation, week 2,4,8,12 | MOBID-2 Pain Scale is a staff-administered behavioural instrument for assessment pain in older persons with dementia (Husebo 2008a). MOBID-2 is based on patient's pain behaviour in connection with standardised, guided movements of different body part, and pain behaviour related to internal organs, head and skin. Additionally, pain will be registered by pain diagnoses, -etiology, and -duration. The MOBID-2 score is derived from caregiver in a clinical bedside situation during morning care. Administration of the MOBID-2 takes approximately 5 minutes. |
| Secondary | Functional Assessment Staging (FAST) | Screening and week 8 | FAST describes a continuum of seven stages and sub stages from normality to most severe dementia (Hughes 1982). Moderate to severe dementia is consistent with Fast stage of 5 or 6 or 7. Stage 5 is defined as moderately severe cognitive decline, with deficient performance in activities of daily living such as choosing proper clothing and maintaining hygiene. Stage 6 is defined as severe cognitive decline with incontinence and decreased ability to clothe, bathe, toilet oneself, severely limited speech, vocabulary, emotional expression. FAST score is derived from caregiver interview (5 min). |
| Secondary | Adverse events (AE) and serious adverse event (SAE) | week 2,4,8 | Safety and tolerability assessments will consist of monitoring and recording all adverse events (AE) and serious adverse events (SAE) and the regular monitoring of vital signs (BP, puls); AE and SAE registration and report is related to each patient, each medication each centre with reportation to the Norwegian Medicines Agency (study code EUDRACTNR. 2008-007490-20). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01021696
GET https://conductscience.org/api/trials/v1/NCT01021696/registered