AgingPhase 2/3ACTIVENCT00298558
ACTIVE: Advanced Cognitive Training for Independent and Vital Elderly
A Phase 2/3 study testing Cognitive Training in people with Aging and Healthy, run by Carelon Research at 7 sites in United States.
Trial summary
The purpose of the ACTIVE study was to test if cognitive training interventions could maintain functional independence in elders by improving basic mental abilities, with follow-up assessments through five years. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- What is being tested?
- Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,832 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 1998to Dec 2010
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65 or older
- Mini-Mental State Examination (MMSE) score 23 or greater
- Vision scored greater than 20/50
- Minimal dependence in hygiene, bathing, and dressing
Who cannot join
- Significant decline in cognitive skills, physical abilities, or functional independence
- Inability to complete study activities as evidenced by MMSE and vision scores lower than Inclusion Criteria requirement
- Diagnosis of Alzheimer's disease
- Stroke in previous 12 months
- Cancer with limited life expectance
- Current chemotherapy or radiation treatment
Show all 10Show fewer
- Communication problems
- Planned move from study area
- Scheduling conflicts that would preclude participation in study activities
- Prior involvement in similar cognitive training studies
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Johns Hopkins University
Baltimore, Maryland, 21205
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Hebrew Rehabilitation Center for the Aged
Boston, Massachusetts, 02131
Johns Hopkins University
Cumberland, Maryland, 21205
Wayne State University
Detroit, Michigan, 48202
Indiana University
Indianapolis, Indiana, 46202
Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
Official title: Trial of a Cognitive Intervention for Older Adults
The purpose of the ACTIVE study was to test if cognitive training interventions could maintain functional independence in elders by improving basic mental abilities, with follow-up assessments through five years.
Read the detailed description
ACTIVE was a 4-arm, single-blind, randomized controlled trial. The primary objective of ACTIVE was to test the effectiveness and durability of three distinct cognitive interventions in improving elders' performance on basic measures of cognition and measures of cognitively demanding daily activities (e.g., food preparation, driving, medication use, financial management). These interventions previously had been found successful in improving cognitive abilities under laboratory or small-scale field conditions.
The three interventions shared common design features: 1) equivalent intensity and duration; 2) small group settings in ten 60-75 minute sessions; 3) focus on strategies for solving problems, remembering, or responding quickly to information; 4) modeling and demonstration of strategy usage; 5) practice on exemplar problems; 6) individual and group exercises; 7) feedback on performance; 8) fostering of self-efficacy regarding performance; 9) applying strategies to real-world tasks; 10) individualized training experiences, and 11) social interaction activities. In all three interventions, Sessions 1-5 focused on strategy instruction and exercises to practice the strategy. Sessions 6-10 provided additional practice exercises, but no new strategies were introduced. Content for each of the 10 sessions was scripted in a trainer's manual.
Interventions:
- Reasoning training focused on inductive reasoning, the ability to solve problems that follow a serial pattern and manifest in executive functioning. Participants were taught strategies to identify the pattern or sequence required to solve a problem. Training exercises involved identifying patterns in both laboratory-type reasoning tasks and in everyday activities, e.g., understanding the pattern in a bus schedule.
- Memory training focused on verbal episodic memory, which deals with acquisition and retrieval of information acquired in a particular place at a particular time. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information. Training exercises involved recalling laboratory-like episodic memory tasks as well as tasks related to everyday activities such as recalling a shopping list.
- Speed training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format, with and without distractors. Participants practiced speeded tasks on a computer, and were allowed to proceed to more complex tasks, and faster and faster presentation speeds at their own pace.
- A control group received no training.
In addition, booster training was provided to help participants maintain gains made from initial training and to further improve cognitive skills. Booster training was provided to a random sample of approximately 50% of training participants at 11 and 35-36 months after primary training.
Participant involvement included assessments conducted at baseline, immediately post-intervention, and at 12, 24, 36 and 60 months. Assessments were conducted in individual and group sessions. For participants randomized to intervention groups, the interventions were conducted in small group settings in ten 60-75 minute sessions over a 5-6 week period. These were behavioral interventions with no pharmacologic component. Eleven months after the initial training was provided, booster training was offered, in all three intervention arms, to a randomly selected 60% of initially trained subjects. Booster training was delivered in four 75-minute sessions over a 2-3 week period.
The primary study hypotheses were:
- Each training group will perform better than the other training and control groups on their respective primary and proximal outcomes
- Those groups that received booster training will perform better than those that did not receive booster training on their respective primary and proximal outcomes.
- Being tested
- Cognitive Training
- Keywords
- cognition disorder, cognitive behavior therapy, functional ability
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TrainingBehavioural
Memory, Reasoning, or Speed of Processing cognitive training interventions
| Study group | Role | What they receive |
|---|---|---|
| Memory Training | Active comparator | Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information. Receives: Behavioral: Cognitive Training |
| Reasoning Training | Active comparator | Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem. Receives: Behavioral: Cognitive Training |
| Speed of Processing Training | Active comparator | Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer. Receives: Behavioral: Cognitive Training |
| Control | Placebo comparator | This group did not complete any cognitive training interventions Receives: Behavioral: Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Cognitive Abilities of Memory From Baseline to Year 10
Memory outcome was computed as the summation of Rey Auditory-Verbal Learning Test (AVLT), the Hopkins Verbal Learning Test (HVLT), and the Rivermead Behavioral Paragraph Recall test immediate recall. The possible range of the memory outcome is 0 to 132. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.
Measured: Up to 10 years
Changes in Cognitive Abilities of Reasoning From Baseline to Year 10
Reasoning outcome was computed as the summation of total correct for Letter Series, Letter Sets, and Word Series. The possible range of the reasoning outcome is 0 to 75. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.
Measured: Up to 10 years
Changes in Cognitive Abilities of Speed of Processing From Baseline to Year 10
Speed of processing outcome was computed as the summation of three Useful Field of View tasks requiring identification and localization of information, with 75% accuracy, under varying levels of cognitive demand. For the analysis, the reversed score was used and the possible range of the reversed speed of processing outcome is 0 to 1500. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.
Measured: Up to 10 years
Changes in Instrumental Activities of Daily Living (IADL) Difficulty From Baseline to Year 10
The self-reported measure of everyday IADL function was the summation of the IADL difficulty sub-scores from the Minimum Dataset - Home Care (MDS-HC) which assesses performance in the past 7 days on 19 daily tasks spanning meal preparation, housework, finances, health care, telephone, shopping, travel, and need for assistance in dressing, personal hygiene, and bathing. For the analysis, the reversed score was used and the possible range of the reversed everyday IADL function outcome is 0 to 38. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.
Measured: Up to 10 years
Changes in Everyday Problem Solving From Baseline to Year 10
Everyday Problem Solving was computed as the summation of the Everyday Problems Test (EPT) and Observed Tasks of Daily Living (OTDL). The possible range of the everyday problem solving outcome is 0 to 56. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.
Measured: Up to 10 years
Changes in Everyday Speed of Processing From Baseline to Year 10
Everyday Speed of processing was computed as the summation of Complex Reaction Time (CRT) and Timed IADL (TIADL). For the analysis, the reversed score was used and the possible range of the reversed everyday speed of processing outcome is -3 to 100. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.
Measured: Up to 10 years
Secondary outcomes (3)
Changes in Health-related Quality of Life (HRQol), Driving Function, Health Service Use
To determine if the cognitive interventions have beneficial effects on the distal outcomes of driving safety, personal care activities of daily living, health service utilization, and mortality.
Measured: 10th Year
Examine Health, Genetic and Cognitive Moderators
To examine heath, genetic, and cognitive moderators (including cardiovascular disease,diabetes, depression, Apolipoprotein E (APOE) genotype, and low cognition and engagement) in individual response to training.
Measured: 10th Year
Estimate the Effects of ACTIVE Training to General Population
To estimate and project the effects of ACTIVE training to the general population of older adults by linking the measures and outcomes of ACTIVE to the Health and Retirement Study(and its subsidiary studies), a population-based, nationally-representative cohort.
Measured: 10th Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2006 (estimated)
- Study startMar 1998
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (56)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,832 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carelon Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Karlene Ball, PhD, Principal investigator, University of Alabama at BirminghamFrederick Unverzagt, PhD, Principal investigator, Indiana UniversityGeorge Rebok, PhD, Principal investigator, Johns Hopkins UniversityJohn Morris, PhD, Principal investigator, Hebrew Senior LifeSharon L. Tennstedt, PhD, Principal investigator, Carelon ResearchMichael Marsiske, PhD, Principal investigator, Wayne State UniversitySherry Willis, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298558
- Sponsor's protocol ID
- IA0091
- Other IDs
- U01NR004507, U01NR004508, U01AG014260, U01AG014282, U01AG014263, U01AG014289, U01AG014276
- Acronym
- ACTIVE
- Status last verified
- Jan 2014
- First submitted
- 28 Feb 2006
- Last updated
- 16 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Jobe JB, Smith DM, Ball K, Tennstedt SL, Marsiske M, Willis SL, Rebok GW, Morris JN, Helmers KF, Leveck MD, Kleinman K. ACTIVE: a cognitive intervention trial to promote independence in older adults. Control Clin Trials. 2001 Aug;22(4):453-79. doi: 10.1016/s0197-2456(01)00139-8.
PubMed 11514044Jones RN, Rosenberg AL, Morris JN, Allaire JC, McCoy KJ, Marsiske M, Kleinman KP, Rebok GW, Malloy PF. A growth curve model of learning acquisition among cognitively normal older adults. Exp Aging Res. 2005 Jul-Sep;31(3):291-312. doi: 10.1080/03610730590948195.
PubMed 16036723Kuo HK, Jones RN, Milberg WP, Tennstedt S, Talbot L, Morris JN, Lipsitz LA. Cognitive function in normal-weight, overweight, and obese older adults: an analysis of the Advanced Cognitive Training for Independent and Vital Elderly cohort. J Am Geriatr Soc. 2006 Jan;54(1):97-103. doi: 10.1111/j.1532-5415.2005.00522.x.
PubMed 16420204Diehl M, Marsiske M, Horgas AL, Rosenberg A, Saczynski JS, Willis SL. The Revised Observed Tasks of Daily Living: A Performance-Based Assessment of Everyday Problem Solving in Older Adults. J Appl Gerontol. 2005;24(3):211-230. doi: 10.1177/0733464804273772.
PubMed 18160968Wadley VG, Crowe M, Marsiske M, Cook SE, Unverzagt FW, Rosenberg AL, Rexroth D. Changes in everyday function in individuals with psychometrically defined mild cognitive impairment in the Advanced Cognitive Training for Independent and Vital Elderly Study. J Am Geriatr Soc. 2007 Aug;55(8):1192-8. doi: 10.1111/j.1532-5415.2007.01245.x.
PubMed 17661957Cook SE, Marsiske M, Thomas KR, Unverzagt FW, Wadley VG, Langbaum JB, Crowe M. Identification of mild cognitive impairment in ACTIVE: algorithmic classification and stability. J Int Neuropsychol Soc. 2013 Jan;19(1):73-87. doi: 10.1017/S1355617712000938. Epub 2012 Oct 25.
PubMed 23095218Owsley C, Sloane M, McGwin G Jr, Ball K. Timed instrumental activities of daily living tasks: relationship to cognitive function and everyday performance assessments in older adults. Gerontology. 2002 Jul-Aug;48(4):254-65. doi: 10.1159/000058360.
PubMed 12053117Gallo JJ, Rebok GW, Tennsted S, Wadley VG, Horgas A; Advanced Cognitive Training for Independent and Vital Elderly (Active) Study Investigators. Linking depressive symptoms and functional disability in late life. Aging Ment Health. 2003 Nov;7(6):469-80. doi: 10.1080/13607860310001594736.
PubMed 14578009Caskie GI, Willis SL. Congruence of self-reported medications with pharmacy prescription records in low-income older adults. Gerontologist. 2004 Apr;44(2):176-85. doi: 10.1093/geront/44.2.176.
PubMed 15075414Edwards JD, Ross LA, Wadley VG, Clay OJ, Crowe M, Roenker DL, Ball KK. The useful field of view test: normative data for older adults. Arch Clin Neuropsychol. 2006 May;21(4):275-86. doi: 10.1016/j.acn.2006.03.001. Epub 2006 May 15.
PubMed 16704918Wolinsky FD, Unverzagt FW, Smith DM, Jones R, Wright E, Tennstedt SL. The effects of the ACTIVE cognitive training trial on clinically relevant declines in health-related quality of life. J Gerontol B Psychol Sci Soc Sci. 2006 Sep;61(5):S281-7. doi: 10.1093/geronb/61.5.s281.
PubMed 16960242Crowe M, Andel R, Wadley V, Cook S, Unverzagt F, Marsiske M, Ball K. Subjective cognitive function and decline among older adults with psychometrically defined amnestic MCI. Int J Geriatr Psychiatry. 2006 Dec;21(12):1187-92. doi: 10.1002/gps.1639.
PubMed 16955448Kuo HK, Jones RN, Milberg WP, Tennstedt S, Talbot L, Morris JN, Lipsitz LA. Effect of blood pressure and diabetes mellitus on cognitive and physical functions in older adults: a longitudinal analysis of the advanced cognitive training for independent and vital elderly cohort. J Am Geriatr Soc. 2005 Jul;53(7):1154-61. doi: 10.1111/j.1532-5415.2005.53368.x.
PubMed 16108933Wolinsky FD, Unverzagt FW, Smith DM, Jones R, Stoddard A, Tennstedt SL. The ACTIVE cognitive training trial and health-related quality of life: protection that lasts for 5 years. J Gerontol A Biol Sci Med Sci. 2006 Dec;61(12):1324-9. doi: 10.1093/gerona/61.12.1324.
PubMed 17234829Ball K, Edwards JD, Ross LA. The impact of speed of processing training on cognitive and everyday functions. J Gerontol B Psychol Sci Soc Sci. 2007 Jun;62 Spec No 1:19-31. doi: 10.1093/geronb/62.special_issue_1.19.
PubMed 17565162
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of a Cognitive Intervention for Older Adults
- ClinicalTrials.gov ID
- NCT00298558
- Acronym / sponsor ID
- ACTIVE / IA0091
- Keywords
- cognition disorder, cognitive behavior therapy, functional ability
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,832 participants (actual)
- Lead sponsor
- Carelon ResearchUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institute of Nursing Research (NINR)
- Study start
- Mar 1998
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 2 Mar 2006 (estimated)
- Results
- Posted 24 Feb 2014
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 the ACTIVE study was to test if cognitive training interventions could maintain functional independence in elders by improving basic mental abilities, with follow-up assessments through five years.
Detailed description
ACTIVE was a 4-arm, single-blind, randomized controlled trial. The primary objective of ACTIVE was to test the effectiveness and durability of three distinct cognitive interventions in improving elders' performance on basic measures of cognition and measures of cognitively demanding daily activities (e.g., food preparation, driving, medication use, financial management). These interventions previously had been found successful in improving cognitive abilities under laboratory or small-scale field conditions.
The three interventions shared common design features: 1) equivalent intensity and duration; 2) small group settings in ten 60-75 minute sessions; 3) focus on strategies for solving problems, remembering, or responding quickly to information; 4) modeling and demonstration of strategy usage; 5) practice on exemplar problems; 6) individual and group exercises; 7) feedback on performance; 8) fostering of self-efficacy regarding performance; 9) applying strategies to real-world tasks; 10) individualized training experiences, and 11) social interaction activities. In all three interventions, Sessions 1-5 focused on strategy instruction and exercises to practice the strategy. Sessions 6-10 provided additional practice exercises, but no new strategies were introduced. Content for each of the 10 sessions was scripted in a trainer's manual.
Interventions:
- Reasoning training focused on inductive reasoning, the ability to solve problems that follow a serial pattern and manifest in executive functioning. Participants were taught strategies to identify the pattern or sequence required to solve a problem. Training exercises involved identifying patterns in both laboratory-type reasoning tasks and in everyday activities, e.g., understanding the pattern in a bus schedule.
- Memory training focused on verbal episodic memory, which deals with acquisition and retrieval of information acquired in a particular place at a particular time. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information. Training exercises involved recalling laboratory-like episodic memory tasks as well as tasks related to everyday activities such as recalling a shopping list.
- Speed training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format, with and without distractors. Participants practiced speeded tasks on a computer, and were allowed to proceed to more complex tasks, and faster and faster presentation speeds at their own pace.
- A control group received no training.
In addition, booster training was provided to help participants maintain gains made from initial training and to further improve cognitive skills. Booster training was provided to a random sample of approximately 50% of training participants at 11 and 35-36 months after primary training.
Participant involvement included assessments conducted at baseline, immediately post-intervention, and at 12, 24, 36 and 60 months. Assessments were conducted in individual and group sessions. For participants randomized to intervention groups, the interventions were conducted in small group settings in ten 60-75 minute sessions over a 5-6 week period. These were behavioral interventions with no pharmacologic component. Eleven months after the initial training was provided, booster training was offered, in all three intervention arms, to a randomly selected 60% of initially trained subjects. Booster training was delivered in four 75-minute sessions over a 2-3 week period.
The primary study hypotheses were:
- Each training group will perform better than the other training and control groups on their respective primary and proximal outcomes
- Those groups that received booster training will perform better than those that did not receive booster training on their respective primary and proximal outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Memory Training | Active comparator | Behavioral: Cognitive TrainingMemory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information. |
| Reasoning Training | Active comparator | Behavioral: Cognitive TrainingReasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem. |
| Speed of Processing Training | Active comparator | Behavioral: Cognitive TrainingSpeed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer. |
| Control | Placebo comparator | Behavioral: Cognitive TrainingThis group did not complete any cognitive training interventions |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age 65 or older
- Mini-Mental State Examination (MMSE) score 23 or greater
- Vision scored greater than 20/50
- Minimal dependence in hygiene, bathing, and dressing
Key exclusion criteria (10 listed)
- Significant decline in cognitive skills, physical abilities, or functional independence
- Inability to complete study activities as evidenced by MMSE and vision scores lower than Inclusion Criteria requirement
- Diagnosis of Alzheimer's disease
- Stroke in previous 12 months
- Cancer with limited life expectance
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 |
|---|---|---|
| Cognitive TrainingMemory, Reasoning, or Speed of Processing cognitive training interventions | Behavioural | Control, Memory Training, Reasoning Training, Speed of Processing Training |
Primary outcome
Changes in Cognitive Abilities of Memory From Baseline to Year 10
Time frame: Up to 10 years
Memory outcome was computed as the summation of Rey Auditory-Verbal Learning Test (AVLT), the Hopkins Verbal Learning Test (HVLT), and the Rivermead Behavioral Paragraph Recall test immediate recall. The possible range of the memory outcome is 0 to 132. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.
Changes in Cognitive Abilities of Reasoning From Baseline to Year 10
Time frame: Up to 10 years
Reasoning outcome was computed as the summation of total correct for Letter Series, Letter Sets, and Word Series. The possible range of the reasoning outcome is 0 to 75. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.
Changes in Cognitive Abilities of Speed of Processing From Baseline to Year 10
Time frame: Up to 10 years
Speed of processing outcome was computed as the summation of three Useful Field of View tasks requiring identification and localization of information, with 75% accuracy, under varying levels of cognitive demand. For the analysis, the reversed score was used and the possible range of the reversed speed of processing outcome is 0 to 1500. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.
Changes in Instrumental Activities of Daily Living (IADL) Difficulty From Baseline to Year 10
Time frame: Up to 10 years
The self-reported measure of everyday IADL function was the summation of the IADL difficulty sub-scores from the Minimum Dataset - Home Care (MDS-HC) which assesses performance in the past 7 days on 19 daily tasks spanning meal preparation, housework, finances, health care, telephone, shopping, travel, and need for assistance in dressing, personal hygiene, and bathing. For the analysis, the reversed score was used and the possible range of the reversed everyday IADL function outcome is 0 to 38. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.
Changes in Everyday Problem Solving From Baseline to Year 10
Time frame: Up to 10 years
Everyday Problem Solving was computed as the summation of the Everyday Problems Test (EPT) and Observed Tasks of Daily Living (OTDL). The possible range of the everyday problem solving outcome is 0 to 56. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.
Changes in Everyday Speed of Processing From Baseline to Year 10
Time frame: Up to 10 years
Everyday Speed of processing was computed as the summation of Complex Reaction Time (CRT) and Timed IADL (TIADL). For the analysis, the reversed score was used and the possible range of the reversed everyday speed of processing outcome is -3 to 100. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.
3 secondary outcomes
Changes in Health-related Quality of Life (HRQol), Driving Function, Health Service Use
Time frame: 10th Year
Examine Health, Genetic and Cognitive Moderators
Time frame: 10th Year
Estimate the Effects of ACTIVE Training to General Population
Time frame: 10th Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11514044Jobe JB, Smith DM, Ball K, Tennstedt SL, Marsiske M, Willis SL, Rebok GW, Morris JN, Helmers KF, Leveck MD, Kleinman K. ACTIVE: a cognitive intervention trial to promote independence in older adults. Control Clin Trials. 2001 Aug;22(4):453-79. doi: 10.1016/s0197-2456(01)00139-8.
- Background: PubMed 16036723Jones RN, Rosenberg AL, Morris JN, Allaire JC, McCoy KJ, Marsiske M, Kleinman KP, Rebok GW, Malloy PF. A growth curve model of learning acquisition among cognitively normal older adults. Exp Aging Res. 2005 Jul-Sep;31(3):291-312. doi: 10.1080/03610730590948195.
- Background: PubMed 16420204Kuo HK, Jones RN, Milberg WP, Tennstedt S, Talbot L, Morris JN, Lipsitz LA. Cognitive function in normal-weight, overweight, and obese older adults: an analysis of the Advanced Cognitive Training for Independent and Vital Elderly cohort. J Am Geriatr Soc. 2006 Jan;54(1):97-103. doi: 10.1111/j.1532-5415.2005.00522.x.
- Background: PubMed 18160968Diehl M, Marsiske M, Horgas AL, Rosenberg A, Saczynski JS, Willis SL. The Revised Observed Tasks of Daily Living: A Performance-Based Assessment of Everyday Problem Solving in Older Adults. J Appl Gerontol. 2005;24(3):211-230. doi: 10.1177/0733464804273772.
- Background: PubMed 17661957Wadley VG, Crowe M, Marsiske M, Cook SE, Unverzagt FW, Rosenberg AL, Rexroth D. Changes in everyday function in individuals with psychometrically defined mild cognitive impairment in the Advanced Cognitive Training for Independent and Vital Elderly Study. J Am Geriatr Soc. 2007 Aug;55(8):1192-8. doi: 10.1111/j.1532-5415.2007.01245.x.
- Background: PubMed 23095218Cook SE, Marsiske M, Thomas KR, Unverzagt FW, Wadley VG, Langbaum JB, Crowe M. Identification of mild cognitive impairment in ACTIVE: algorithmic classification and stability. J Int Neuropsychol Soc. 2013 Jan;19(1):73-87. doi: 10.1017/S1355617712000938. Epub 2012 Oct 25.
- Background: PubMed 12053117Owsley C, Sloane M, McGwin G Jr, Ball K. Timed instrumental activities of daily living tasks: relationship to cognitive function and everyday performance assessments in older adults. Gerontology. 2002 Jul-Aug;48(4):254-65. doi: 10.1159/000058360.
- Background: PubMed 14578009Gallo JJ, Rebok GW, Tennsted S, Wadley VG, Horgas A; Advanced Cognitive Training for Independent and Vital Elderly (Active) Study Investigators. Linking depressive symptoms and functional disability in late life. Aging Ment Health. 2003 Nov;7(6):469-80. doi: 10.1080/13607860310001594736.
- Background: PubMed 15075414Caskie GI, Willis SL. Congruence of self-reported medications with pharmacy prescription records in low-income older adults. Gerontologist. 2004 Apr;44(2):176-85. doi: 10.1093/geront/44.2.176.
- Background: PubMed 16704918Edwards JD, Ross LA, Wadley VG, Clay OJ, Crowe M, Roenker DL, Ball KK. The useful field of view test: normative data for older adults. Arch Clin Neuropsychol. 2006 May;21(4):275-86. doi: 10.1016/j.acn.2006.03.001. Epub 2006 May 15.
- Background: PubMed 16960242Wolinsky FD, Unverzagt FW, Smith DM, Jones R, Wright E, Tennstedt SL. The effects of the ACTIVE cognitive training trial on clinically relevant declines in health-related quality of life. J Gerontol B Psychol Sci Soc Sci. 2006 Sep;61(5):S281-7. doi: 10.1093/geronb/61.5.s281.
- Background: PubMed 16955448Crowe M, Andel R, Wadley V, Cook S, Unverzagt F, Marsiske M, Ball K. Subjective cognitive function and decline among older adults with psychometrically defined amnestic MCI. Int J Geriatr Psychiatry. 2006 Dec;21(12):1187-92. doi: 10.1002/gps.1639.
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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.
Karlene Ball, PhD principal investigator
University of Alabama at Birmingham
Frederick Unverzagt, PhD principal investigator
Indiana University
George Rebok, PhD principal investigator
Johns Hopkins University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cognitive Training in people with Aging and Healthy, run by Carelon Research at 7 sites in United States.
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 10 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: finished, as of the sponsor's last update on 16 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Cognitive Abilities of Memory From Baseline to Year 10 (time frame: Up to 10 years). The study lists 6 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 NCT00298558, which also lists 56 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 16 Apr 2014.